DR.Mojibian 1390 The Ob-Gyn Clerkship: Your Guide to Success Tools for the Clerkship, contained in this document: 1. 2. 3. 4. 5. 6. 7. 8. Sample obstetrics admission note Sample delivery note Sample operative note Sample postpartum note a. Vaginal delivery b. Cesarean section orders/note Sample gynecologic history & physical (H&P) Admission orders Commonly-used abbreviations Spanish lesson 1 DR.Mojibian 1. 1390 Sample Admission to Labor and Delivery Note Date & time Identification (includes age, gravidity, parity, estimated gestational age, and reason for admission): 26yo G3P1A1 @ 38W5D EGA presents with painful contractions since noon. Pt reports good fetal movement, and denies rupture of membranes or vaginal bleeding. LMP: Estimated date of confinement (EDC): Chief complaint: History of present illness (includes Prenatal Care (PNC): Labs, including HIV, GBS, GDM/HTN, # PNC visits, wt gain, s=d, etc. Past history: Obstetrics: List each pregnancy (NSVD, wt 4000 grams, complicated by gestational diabetes and shoulder dystocia) Gynecology: PMH and PSH: Medications: PNV, FeSO4 Allergies: No Known Drug Allergies (NKDA) Social history: Ask about Tobacco/EtOH/Drugs Physical exam (focused): General and Vital signs Lungs CV – (Many pregnant women have a grade 1-2/6 systolic ejection murmur Abd – Gravid, fundus non-tender (NT), fundal height (FH) 38cm, Leopold maneuvers: Fetus is vertex (VTX), estimated fetal weight (EFW) 3300 gm Sterile speculum examination if indicated to rule out spontaneous rupture of membranes (SROM) Sterile vaginal exam (SVE) = 4cm/80%/VTX/ –1 as per Dr. Smith/time Ext – No Cyanosis, clubbing or edema (C/C/E), NT Pertinent Labs: Ultrasound: Date: 10 wks by crown-rump length (CRL) Date: 20 wks, no anomalies Assessment: 26yo G3P1 at term, in labor fetal heart rate tracing (FHRT) reassuring Intrauterine pregnancy (IUP) at 39 weeks gestation FHRT – Baseline 140’s, accelerations present, no decelerations Contractions – q 4-5 min Any pertinent past medical or surgical history Plan: Admit to L&D NPO except ice chips IV – D5LR at 125 cc/hr Continuous electronic fetal monitoring CBC, T&S, RPR Anticipate NSVD 2 DR.Mojibian 2. 1390 Sample Delivery Note Date and time: Summary: NSVD of a live male, 3000 gm and Apgars 9/9. Delivered LOA, no nuchal cord, light meconium. Nose and mouth bulb suctioned at perineum; body delivered without difficulty. Cord clamped and cut. Baby handed to nurse. Placenta delivered spontaneously, intact. Fundus firm, minimal bleeding. Placenta appears intact with 3 vessel cord. Perineum and vagina inspected – small 2nd degree perineal laceration repaired under local anesthesia with 2-0 and 3-0 chromic suture in the usual fashion. EBL 350cc. Hemostasis. Pt tolerated procedure well, recovering in LDR. Infant to WBN. 3. Sample Operation Note Date and Time: Pre-op Diagnosis: Symptomatic uterine fibroids or Pregnancy at term, failure to progress` Postop Diagnosis: Same Procedure: TAH/BSO or Cesarean Section Surgeon (Attending): Residents: Anesthesia: GET (general endotracheal, others include spinal, LMA, IV sedation) Complications: None EBL: 300 cc Urine Output: 200 cc, clear at the end of procedure Fluids: 2,500 cc crystalloid (include blood or blood products here) Findings: Exam under anesthesia (EUA) and operative Spécimen: Cervix/uterus Drains: If placed Disposition: Recovery room, Surgical ICU, etc 4a. Sample Postpartum Notes (Soap format) Date and Time: Subjective: Ask every patient about: • Breastfeeding – are they breastfeeding/planning to? How is it going? Baby able to latch on? • Contraceptive plan with relevant sexual history • Lochia (vaginal bleeding) – Clots? How many pads? • Pain – cramps/perineal pain/leg pain? Relief with medication? Do they need more pain meds? Objective: • Vital signs and note tachycardia, elevated or low BP, maximum and current temperature • Focused physical exam including o Heart o Lungs o Breasts: engorged? Nipples – skin intact? o Abd: Soft? Location of the uterine fundus – below umbilicus? Firm? Tender? o Perineum: Assess lochia (blood on pad, how old is pad?) Visually inspect perineum – Hematoma? Edema? Sutures intact? o Extremities: Edema? Cords? Tender? • Postpartum labs: Hemoglobin or hematocrit 3 DR.Mojibian 1390 Assessment/Plan: PPD#_ S/P NSVD or Vacuum or Forceps (with 4th-degree laceration, with pre-eclampsia s/p Magnesium Sulfate) • General assessment – Afebrile, doing well, tolerating diet • Contraception plans (must discuss before patient goes home) • Vaccines – does pt need rubella vaccine prior to discharge? • Breastfeeding? Problems? Encourage. • Rhogam, if Rh-negative • Discharge and follow-up plan • Patients usually go home if uncomplicated 24-48 hours postpartum • Follow-up appointment scheduled in 2-6 weeks postpartum 4b. Sample Postoperative Cesarean Section Orders/Note Sample C/S Orders Admit to Recovery Room, then postpartum floor Diagnosis: Status post (s/p) C/S for failure to progress (FTP) Condition: Stable Vitals: Routine, q shift Allergies: None Activity: Ambulate with assistance this PM, then up ad lib Nursing: Strict input and output (I&O), Foley to catheter drainage, call MD for Temp > 38.4, pulse > 110, BP < 90/60 or > 140/90, encourage breastfeeding, pad count, dressing checks, and Ted’s leg stockings until ambulating Diet: Regular as tolerated; some hospitals only allow ice chips or clear liquids IV: Lactated ringers (LR) or D5LR at 125 cc/hr, with 20 units of Pitocin x 1-2 Liters Labs: CBC in AM Medications: • Morphine sulfate PCA (patient controlled analgesia) per protocol (1 mg per dose with 10 minute lockout, not to exceed 20 mg/4 hours) • Percocet 1-2 tabs PO q 4-6 hours prn pain, when tolerating PO well • Vistaril 25 mg IM or PO q 6 hours prn nausea • Ibuprofen 800 mg PO q 8 hours prn pain, when tolerating PO well • Prophylactic antibiotics if indicated • Thromboprohylaxis for high-risk patients • Rhogam, if Rh-negative Sample C/S Note Date and Time: Day #1 (Post-op day POD#1) Subjective: Ask patient about: • Pain – relieved with medication? • Nausea/vomiting • Passing flatus (rare this early post-op) Objective: • Vital signs and note tachycardia, elevated or low BP, maximum and current temperature • Input and output 4 DR.Mojibian 1390 • Focused physical exam including o Heart o Lungs o Breasts: engorged? Nipples – Is skin intact? o Incision: Clean and dry, intact? o Abd: Soft? Location of the uterine fundus – below umbilicus? Firm? Tender? o Perineum: Assess lochia (blood on pad, how old is pad?) Visually inspect perineum – Hematoma? Edema? Sutures intact? o Extremities: Edema? Cords? Tender? • Postpartum labs: Hemoglobin or hematocrit Assessment/Plan: POD#1 status post (S/P) C/S or repeat C/S (indication for the C/S) • Afebrile, tolerating pain with medication, oral intake, adequate urine output (>30cc/hr) • Routine post-op care o Discharge Foley o Discharge PCA or IV pain medications and PO pain Meds when tolerating PO o Out of bed (OOB) o Advance diet as tolerated o Discharge IV when tolerating PO • Check hematocrit or CBC 5. Sample Gynecologic History and Physical Introduction: Name, age, gravidity, parity and presenting problem HPI: Past Medical History/Past Surgical History: Past Gynecologic History: • Menses – menarche, cycle duration, length, heaviness, intermenstrual bleeding, dysmenorrhea, and menopause (if relevant). • Abnormal Pap smears, including time of last Pap • Sexually transmitted infections • Sexual history • Postmenopausal women. Ask about hypoestrogenic symptoms, such as hot flashes or night sweats, vaginal dryness, and about current and past use of hormone/estrogen replacement therapy. • Mammogram Past OB History: Date of delivery, gestational age, type of delivery, sex, birthweight and any complications Family History: Allergies: Medication s: Social History: Physical Exam: Complete Review of Systems: Plan: 1. Pap smear 2. Endometrial biopsy obtained 3. Medications, etc. Two Sample Gyn Clinic SOAP Notes 5 DR.Mojibian 1390 S. 22 y/o G2P2 here for annual exam. Regular menses q 28 days with no intermenstrual bleeding. IUD for contraception since birth of last child 2 years ago. No problems with method. Minimal dysmenorrhea. Mutually monogamous relationship x 6 years. No hx of abnormal Paps. + BSE, jogs twice a week, no smoking, no abuse, + seat belts. O. Breasts: No masses, adenopathy, skin changes Abd: No masses, soft, NT Pelvic: Ext genitalia: Normal Vagina: pink, moist, well rugated Cervix: multiparous, no lesions Bimanual: uterus small, anteverted, NT, no adnexal masses or tenderness A. Normal exam P. Pap, RTC 1 year * * * * S. 33 y/o G3P1 with LMP 1 week ago here for follow up of chronic left sided pelvic pain. Patient first seen 6 months ago with complaints of pain x 2 years. She describes pain as dull and aching, intermittent, with no relationship to eating but increased before and during menses. Pain has gotten worse over the last 6 months and requires her to miss work 2-3 days per month. No relief with NSAIDs. Patient has history of chlamydia 5 years ago for which she was treated. No history of PID. Three partners within the past year: no condom use No GI symptoms: regular BMs, no constipation, diarrhea, nausea or vomiting. Past history of ectopic x 2 with removal of part of the left and right tubes. Also had ruptured appendectomy at age 20. On birth control pills for contraception. O. Abdomen: 1+ LLQ tenderness, no peritoneal signs Pelvic: Ext genitalia: Normal Vagina: no discharge Cervix: no lesions Biman: uterus small, retroverted, NT, 3+ left adnexal tenderness, no right adnexal tenderness, no masses palpated A. Pelvic pain unresponsive to medical management; rule out endometriosis vs adhesive disease vs chronic PID vs other P. Schedule diagnostic laparoscopy 6 DR.Mojibian 6. 1390 Admission Orders These vary a little from case to case, but the following are fairly general (format is ADC VAN DISMAL): Admit: To the specific service or team Diagnosis: List the diagnosis and the names of any associated surgeries or procedures Condition: Such as Stable vs Fair vs Guarded Vitals: Frequency Activity: Ambulation, showering Nursing: Foley catheter management parameters Prophylaxis for deep venous thrombosis Incentive spirometry protocols Call orders Vital sign parameters for notifying the team Urine output parameters Diet: Oral intake management IVF: Rates are typically set at 125 cc per hour Special: Drain management Oxygen management Meds: Pain medications Prophylactic orders, such as for sleep or nausea The patients' regular medications Allergies: Labs: Typically includes hemoglobin/hematocrit 7 DR.Mojibian 1390 Department of Obstetrics and Gynecology Massive Transfusion Protocol for Obstetrical Hemorrhage I. PRINCIPLE The Massive Transfusion Protocol (MTP) for Obstetrical Hemorrhage is intended for antepartum; intrapartum or postpartum patients deemed candidates based on requirement for massive blood volume replacement. Currently at The University Hospital, University of Cincinnati, an MTP is in place. This protocol has been modified to meet the special needs of the obstetrical hemorrhage patient. II. CLASSIFICATION OF OBSTETRICAL HEMORRHAGE A. LOW RISK: Minimal bleeding with reassuring maternal/fetal status. Vaginal bleeding, which will be expectantly managed. B. MODERATE RISK: Vaginal bleeding which requires active management. Transfusion of blood products as well as fetal/maternal intervention may be necessary. C. HIGH RISK: Vaginal bleeding which requires active management. Transfusion of blood products as well as fetal/maternal intervention will be necessary. A subset of these patients will require the implementation of the Massive Transfusion Protocol. 1. Antepartum presentation to ER or OB Triage with abruption, previa or accrete and DIC from any source. 2. Intrapartum hemorrhage immediately following 3rd stage of labor. 3. Postpartum hemorrhage occurring during recovery period or on postpartum unit. III. IMPLEMENTATION OF MTP (HAVE A LOW THRESHOLD FOR INITIATION) A. Criteria for implementation of MTP (any of below) 1. EBL > 2000 cc with ongoing blood loss of >150 cc/min. Obstetricians under estimate blood loss. (Refer to Box 1: Guidelines for Estimation of Blood Loss) 2. Hypotension decrease of BP by 20% in the setting of acute hemorrhage 3. Tachycardia HR >110 in the setting of acute hemorrhage 4. Mental status changes in the setting of acute hemorrhage 5. Chest pain/EKG changes in the setting of acute hemorrhage 8 6. O2 Saturation <95% with O2 treatment in the setting of acute hemorrhage or significant change in O2 saturation 7. Prior to the onset of hemorrhage in special cases. (See Section IV: INITIATION OF THE MTP PRIOR TO THE ONSET OF VISIBLE HEMORRHAGE) 8. Absence/Decrease in urine output. 9. INR > 1.5 10. Temp < 96.5 11. Base Deficit > -6.0 B. Acceptable scenarios 1. Known accreta 2. Known previa with greater than 2 prior cesarean sections. 3. Strong suspicion of large concealed abruption. 4. Active bleeding disorder at the time of operative delivery 5. In other cases, where there is a very high likelihood for massive obstetrical hemorrhage, the MTP can be implemented prior to a scheduled delivery. Box 1. Guidelines for Estimation of Blood Loss Suction Canister As measured (Side pockets must be suctioned during C/S for accurate measurement) Saturated Laparotomy Pad # Laps x 100 cc Unsaturated Laparotomy Pad # Laps x 50 cc Estimation of Amniotic Fluid Amount subtracted as estimated by surgeon C. Notification of personnel – OB charge nurse (513-584-5422) 1. The following personnel will be notified at the time criteria has been met for implementation of the MTP a. OB Attending (513-325-0304) b. Anesthesia Attending and Team (513-314-2969) c. Notify blood bank of situation (513-584-7888) d. OB Tech (to set up OB OR if necessary)(513-5845740/5741) 2. Call for backup (OB Attending, Gyn Onc [Dr. Richards 513432-2614 Cell], MFM [513-504-6099], Trauma Surgeons [513994-0911]) D. Decision for implementation 1. The decision to implement the MTP must be a joint decision by the OB and Anesthesia attending E. Laboratory Evaluation: (Label, “OR-Obstetrical Crash”) 1. At the implementation of the MTP the following laboratory studies will be sent. a. Type and Match (if not current) (pink tube) b. CBC with Platelets (purple tube) c. PT/PTT/INR (blue tube) d. Fibrinogen (blue tube) e. D-Dimer (blue tube) e. Renal panel, Ionized Calcium, Magnesium (serum separator or red top), Phosphorous f. ABG (blood gas kit) g. VBG (blood gas kit) h. Lactic Acid (grey on ice) 2. This series of laboratory studies will be known as the MTP Lab Panel. 3. The MTP Lab Panel will be sent at the initiation of the MTP and Q 2 hours thereafter until the MTP has been terminated. F. Patient Preparation 1. The patient must have at least 2 - 18G peripheral IV’s 2. The patient must be relocated to a room with capability for central monitoring. Preferably, if the patient is in a labor room she should be transferred to Obstetrical OR Room 4, if possible. 3. Foley catheter will be placed. 4. Continuous pulse oximetry and EKG monitoring. 5. Bair Hugger to maintain Normothermia 6. All intravenous fluids must be warmed through fluid warmers. 7. OR suite must be warmed to 27° Celsius (-80˚F). IV. PROCEDURE FOR IMPLEMENTATION OF MASSIVE TRANSFUSION PROTOCOL A. Notification of Transfusion Services (Obstetrical MTP) 1. The Blood Bank/Crossmatch Lab will be notified of the implementation of the MTP by ONLY one of the following responsible individuals: Attending OB, Attending Anesthesiologist, Chief Resident/Charge-circulating nurse 2. The Blood Bank/Crossmatch Lab will be notified via telephone at 513-584-7888. 3. The patient name, MR #, and patient location must be communicated to the Compatibility/Crossmatch Lab. 4. It is best to say, “I would like to implement the Massive Transfusion Protocol for Obstetrical Hemorrhage…” 5. It is the responsibility of the contacting individual to ensure the appropriate blood specimen has been collected and sent to the Transfusion Service. Of note, most obstetrical patients will have a current Type and Screen and this specimen may not be necessary. Verify that type and screen is current. 6. In acute situations where there is no current Type and Screen, uncross matched O negative trauma blood may be used (location: blood bank 6th floor or main OR refrigerator). This must be authorized by signature on arrival of the blood products by the OB or Anesthesia Attending. B. Acceptable Blood Specimen (Label “OR-Obstetrical Crash”) 1. EDTA (purple or pink) tube appropriately labeled and initialed for blood bank. (PREFERRED) 2. SST, plain red top tube. (ACCEPTABLE) 3. CORVAC tube, hemolyzed specimen, improperly labeled specimen is UNACCEPTIBLE. 4. Specimen may have been stored at 2-8° C for </= 3 days. 5. Nurse needs to label with patient sticker and dated, timed and signed with initials C. Transfusion Service Personnel Duties 1. Perform ABO, Rh typing on specimen. 2. Prepare products per protocol. See Box 2. 3. Continue preparation of new products until protocol is terminated (See Section V. H. : Termination of MTP) 4. Notify the charge nurse area that the products are available. 5. Products will be stored in a cooler for storage and transport. Box 2. Cycle # RBC Plasma Platelets Cryo Massive Transfusion Protocol for Obstetrical Hemorrhage Cooler #1 contents Cooler #2 contents Cooler #3 Contents 6 units P RBC 6 units P RBC 6 units P RBC 4 units FFP 4 units FFP 4 units FFP 5 units pooled or 1 5 units pooled or 1 5 units pooled or 1 aphaeresis product aphaeresis product aphaeresis product 10 Pooled Cryo 10 Pooled Cryo Consider recombinant fader VIIa from Pharmacy IV room 513-584-8847 D. Obtaining Products 1. The OB tech or charge nurse designee will act as the runner to collect the products from the Blood Bank: Room 6158 of University Hospital, 6th floor. E. Transfusion of Products 1. All transfusion, except platelets, will be performed using the Level 1 Fluid Warmer/Infuser 2. Transfusion will proceed in the following order: a. 2 units PRBC b. 2 units FFP c. 5 units pooled platelets d. 2-3 units PRBC e. 2 units FFP f. Repeat Steps a -e g. 10 pooled cryoprecipitate h. Repeat steps f & g as frequently as deemed necessary based on patient’s status and active blood loss F. Documentation 1. Documentation will be maintained during the execution of the MTP including the following items: a. Vital signs Q 10 minutes (Temp, BP, HR, RR) b. Pulse oximetry c. Urine output d. Products administered e. Time of administration of products f. Medications administered g. Time of medication administration h. Laboratory studies 2. It will be the responsibility of the anesthesia team to maintain the above documentation in the OR (as noted in the anesthesia record) and by the charge nurse if patient is in the PACU or preoperative area. 3. All blood transfusion slips will be filed and attached to the chart of the patient by the RN/Anesthesia. G. Termination of MTP 1. The termination of the MTP will only be determined by one of the following responsible individuals: Attending Ob or Attending Anesthesiologist. 2. The Blood Bank/Crossmatch Lab will be notified of the termination of the MTP by ONLY one of the following responsible individuals: Attending OB, and Attending Anesthesiologist, charge nurse. 3. All patients who go to the SICU will be transferred to the Trauma Service. Once on that service, they determine when to stop the protocol. 4. The Blood Bank/Crossmatch Lab will be notified via telephone at 513-584-7888. 5. Call for SICU bed 584-4433. perinatology.com OBPharmacopoeia Home > Reference > OBPharmacopoeia TOC-Public> Pospartum hemorrhage algorithm Postpartum Hemorrhage Algorithm The following algorithm is based the California Maternal Quality Care Collaborative OB Hemorrhage Protocol. Stage 0 Blood Loss less than 500ml with Vaginal delivery; less than 1000 ml with cesarean section. Stable vital signs All women receive active management of 3rd stage Oxytocin IV infusion or 10 Units IM Vigorous fundal massage for 15 seconds minimum Stage 1 Blood Loss > 500ml Vaginal delivery; > 1000 ml cesarean section 15% Vital Sign change -or-HR equal to or greater than 110, BP equal to or less than 85/45 O2 Sat less than 95%, pallor, delayed capillary refill, or decreased urine output. can indicate Decreased urine output, decreased BP and tachycardia may be late signs of compromise Call for help. Provide adequate ventilation Assist airway protection Establish large-bore intravenous access Supplemental O2 5-7 L/min by tight face mask Prepare 2 units of packed red cells. Evaluate for atony, lacerations, hematoma, inverted uterus , retained tissue, accreta, coagulopathy. o Medication for uterine atony Oxytocin 10-40 units in 1 liter NS or LR IV rapid infusion o Methylergonovine (Methergine) 0.2 milligrams intramuscular q 2-4 hrs up to 5 doses Stage 2 1000-1500 ml estimated blood loss with continued bleeding. o Move to operating room Transfuse 2 Units PRBCs per clinical signs Consider thawing 2 Units FFP Order CBC, PT/INR/PTT, Fibrinogen Warm blood products and infusions to prevent hypothermia, coagulopathy and arrhythmias Medication for uterine atony o Prostaglandin F2 Alpha (Hemabate) 250 micrograms intramuscular, intramyometrial, repeat q 15-90 minutes, maximum 8 doses o Prostaglandin E2 suppositories (Dinoprostone, Prostin E2) 20 milligrams per rectum q 2 hrs o Misoprostol (Cytotec) 1000 micrograms per rectum Surgical intervention Vaginal Birth: Atony Bimanual Fundal Massage Retained POC: Dilation and Curettage Lower segment/Implantation site/Atony: Intrauterine Balloon Laceration/Hematoma: Packing, Repair as Required Cesarean Birth: Continued Atony: B-Lynch Suture/Intrauterine Balloon Continued Hemorrhage: Uterine Artery Ligation Hypogastric Ligation (experienced surgeon only) o o o o o o o o Stage 3 Estimated blood loss gretaer than 1500 ml with continued blood loss. o Activate massive transfusion protocol (MTP), MTP "Pack", to be sent from the Blood Bank is: 4 units PRBC 2 OR 4 units FFP 1 apheresis pack of platelets o Obtain CBC , PT/INR/PTT, and fibrinogen every 4 hours after the standard MTP "Pack" is given. Laboratory studies should be monitored for at least 24 hours after discontinuing the protocol. Note: 10 units cryoprecipitate should be given for fibrinogen <100mg/dl o If bleeding continues after 2 MTP packs have been administered, or women is refusing transfusions (e.g. Jehovah Witnesses) , consider recombinant activated factor VII (rFVIIa, NovoSeven®) 60 mcg/kg. May repeat in 30 minutes Surgical intervention o B-Lynch Suture/Intrauterine Balloon o o o Uterine Artery Ligation Hypogastric Ligation (experienced surgeon only) Hysterectomy REFERENCES: 1.http://www.cmqcc.org/resources/ob_hemorrhage/ob_hemorrhage_protocol_tools_release_1_2 2. Burtelow M, Riley E, Druzin M, Fontaine M, Viele M, Goodnough LT. How we treat: management of life-threatening primary postpartum hemorrhage with a standardized massive transfusion protocol. Transfusion. 2007 Sep;47(9):1564-72. PMID: 17725718 3. Malone , MD , LTC USAF, SGRS, D.L., Hess , MD , MPH, J. R., & Fingerhut, MD, A., (2006). Massive Transfusion Practices Around the Globe and a Suggestion for Common Massive Transfusion Protocol. J Trauma , 60, S91-S96. 4. Sobieszczyk S, Breborowicz GH. The use of recombinant factor VIIa in A Textbook of PostPartum Hemorrhage (ed C. B-Lynch et al.). Sapiens Publishing 2006; p 250 5. Franchini M, Franchi M, Bergamini V, Salvagno GL, Montagnana M, Lippi G. A Critical Review on the Use of Recombinant Factor VIIa in Life-Threatening Obstetric Postpartum Hemorrhage. Semin Thromb Hemost 2008; 34: 104-12. 6. O'Connell KA, Wood JJ, Wise RP, Lozier JN, Braun MM. Thromboembolic adverse events after use of recombinant human coagulation factor VIIa. JAMA 2006; 295: 293-8. 7. Hemabate (carboprost tromethamine) package insert. Pharmacia & Upjohn Co., Division of Pfizer Inc, NY, NY 10017. FDA rev date: march 2006 8. . O'Brien P, et al. Rectally administered misoprostol for the treatment of postpartum hemorrhage unresponsive to oxytocin and ergometrine: a descriptive study.Obstet Gynecol. 1998 Aug;92(2):212-4. PMID: 9699753 9. Methergine package insert. Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. FDA Rev date: 4/26/2007 THE INFORMATION IN THE OBPHARMACOPOEIATM IS INTENDED SOLELY FOR USE BY THE MEDICAL PROFESSION. IT IS NOT INTENDED FOR LAY PERSONS. FOCUS INFORMATION TECHNOLOGY, INC. DOES NOT ASSUME ANY RESPONSIBILITY FOR ANY ASPECT OF HEALTHCARE ADMINISTERED WITH THE AID OF THIS CONTENT. THE PRESCRIBING PHYSICIAN MUST BE FAMILIAR WITH THE FULL PRODUCT LABELING AS PROVIDED BY THE MANUFACTURER AND RELEVANT MEDICAL LITERATURE PRIOR TO USING THE OBPHARMACOPOEIATM . Home | About | Disclaimer | Privacy | Contact Copyright © 2009 by Focus Information Technology. All rights reserved perinatology.com OBPharmacopoeia Home > Reference > OBPharmacopoeia TOC-Public> Pospartum hemorrhage algorithm Postpartum Hemorrhage Algorithm The following algorithm is based the California Maternal Quality Care Collaborative OB Hemorrhage Protocol. Stage 0 Blood Loss less than 500ml with Vaginal delivery; less than 1000 ml with cesarean section. Stable vital signs All women receive active management of 3rd stage Oxytocin IV infusion or 10 Units IM Vigorous fundal massage for 15 seconds minimum Stage 1 Blood Loss > 500ml Vaginal delivery; > 1000 ml cesarean section 15% Vital Sign change -or-HR equal to or greater than 110, BP equal to or less than 85/45 O2 Sat less than 95%, pallor, delayed capillary refill, or decreased urine output. can indicate Decreased urine output, decreased BP and tachycardia may be late signs of compromise Call for help. Provide adequate ventilation Assist airway protection Establish large-bore intravenous access Supplemental O2 5-7 L/min by tight face mask Prepare 2 units of packed red cells. Evaluate for atony, lacerations, hematoma, inverted uterus , retained tissue, accreta, coagulopathy. o Medication for uterine atony Oxytocin 10-40 units in 1 liter NS or LR IV rapid infusion o Methylergonovine (Methergine) 0.2 milligrams intramuscular q 2-4 hrs up to 5 doses Stage 2 1000-1500 ml estimated blood loss with continued bleeding. o Move to operating room Transfuse 2 Units PRBCs per clinical signs Consider thawing 2 Units FFP Order CBC, PT/INR/PTT, Fibrinogen Warm blood products and infusions to prevent hypothermia, coagulopathy and arrhythmias Medication for uterine atony o Prostaglandin F2 Alpha (Hemabate) 250 micrograms intramuscular, intramyometrial, repeat q 15-90 minutes, maximum 8 doses o Prostaglandin E2 suppositories (Dinoprostone, Prostin E2) 20 milligrams per rectum q 2 hrs o o o o o o o o o Misoprostol (Cytotec) 1000 micrograms per rectum Surgical intervention Vaginal Birth: Atony Bimanual Fundal Massage Retained POC: Dilation and Curettage Lower segment/Implantation site/Atony: Intrauterine Balloon Laceration/Hematoma: Packing, Repair as Required Cesarean Birth: Continued Atony: B-Lynch Suture/Intrauterine Balloon Continued Hemorrhage: Uterine Artery Ligation Hypogastric Ligation (experienced surgeon only) Stage 3 Estimated blood loss gretaer than 1500 ml with continued blood loss. o Activate massive transfusion protocol (MTP), MTP "Pack", to be sent from the Blood Bank is: 4 units PRBC 2 OR 4 units FFP 1 apheresis pack of platelets o Obtain CBC , PT/INR/PTT, and fibrinogen every 4 hours after the standard MTP "Pack" is given. Laboratory studies should be monitored for at least 24 hours after discontinuing the protocol. Note: 10 units cryoprecipitate should be given for fibrinogen <100mg/dl o If bleeding continues after 2 MTP packs have been administered, or women is refusing transfusions (e.g. Jehovah Witnesses) , consider recombinant activated factor VII (rFVIIa, NovoSeven®) 60 mcg/kg. May repeat in 30 minutes Surgical intervention o B-Lynch Suture/Intrauterine Balloon o Uterine Artery Ligation o Hypogastric Ligation (experienced surgeon only) o Hysterectomy REFERENCES: 1.http://www.cmqcc.org/resources/ob_hemorrhage/ob_hemorrhage_protocol_tools_release_1_2 2. Burtelow M, Riley E, Druzin M, Fontaine M, Viele M, Goodnough LT. How we treat: management of life-threatening primary postpartum hemorrhage with a standardized massive transfusion protocol. Transfusion. 2007 Sep;47(9):1564-72. PMID: 17725718 3. Malone , MD , LTC USAF, SGRS, D.L., Hess , MD , MPH, J. R., & Fingerhut, MD, A., (2006). Massive Transfusion Practices Around the Globe and a Suggestion for Common Massive Transfusion Protocol. J Trauma , 60, S91-S96. 4. Sobieszczyk S, Breborowicz GH. The use of recombinant factor VIIa in A Textbook of PostPartum Hemorrhage (ed C. B-Lynch et al.). Sapiens Publishing 2006; p 250 5. Franchini M, Franchi M, Bergamini V, Salvagno GL, Montagnana M, Lippi G. A Critical Review on the Use of Recombinant Factor VIIa in Life-Threatening Obstetric Postpartum Hemorrhage. Semin Thromb Hemost 2008; 34: 104-12. 6. O'Connell KA, Wood JJ, Wise RP, Lozier JN, Braun MM. Thromboembolic adverse events after use of recombinant human coagulation factor VIIa. JAMA 2006; 295: 293-8. 7. Hemabate (carboprost tromethamine) package insert. Pharmacia & Upjohn Co., Division of Pfizer Inc, NY, NY 10017. FDA rev date: march 2006 8. . O'Brien P, et al. Rectally administered misoprostol for the treatment of postpartum hemorrhage unresponsive to oxytocin and ergometrine: a descriptive study.Obstet Gynecol. 1998 Aug;92(2):212-4. PMID: 9699753 9. Methergine package insert. Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. FDA Rev date: 4/26/2007 THE INFORMATION IN THE OBPHARMACOPOEIATM IS INTENDED SOLELY FOR USE BY THE MEDICAL PROFESSION. IT IS NOT INTENDED FOR LAY PERSONS. FOCUS INFORMATION TECHNOLOGY, INC. DOES NOT ASSUME ANY RESPONSIBILITY FOR ANY ASPECT OF HEALTHCARE ADMINISTERED WITH THE AID OF THIS CONTENT. THE PRESCRIBING PHYSICIAN MUST BE FAMILIAR WITH THE FULL PRODUCT LABELING AS PROVIDED BY THE MANUFACTURER AND RELEVANT MEDICAL LITERATURE PRIOR TO USING THE OBPHARMACOPOEIATM . Home | About | Disclaimer | Privacy | Contact Copyright © 2009 by Focus Information Technology. All rights reserved WHO guidelines for the management of postpartum haemorrhage and retained placenta WHO guidelines for the management of postpartum haemorrhage and retained placenta summarized in the GRADE tables. However, they were mentioned in the evidence summary and taken into account in the recommendation. GRADE tables were not prepared for case series or reports. The draft GRADE tables were reviewed by the WHO Secretariat together with CREP staff. Recommendations relating to the questions and outcomes proposed were then drafted ahead of the Technical Consultation. A draft of the methodology, results, and recommendations was sent for review to a subgroup of the experts participating in the Technical Consultation before the meeting. Decision-making during the technical consultation For each question, the participants in the Technical Consultation discussed the draft text prepared by the Secretariat, with the aim of reaching a consensus. Consensus was defined as agreement by the majority of participants, provided that those who disagreed did not feel strongly about their position. Any strong disagreements were recorded as such. During the meeting, in addition to the documentation prepared by the Secretariat, preliminary results from four unpublished trials were made available. While the presentation of the most recent data from large trials was welcomed and used to inform the recommendations, some participants expressed a need for more time to review these results before making recommendations. The GRADE tables in this document include evidence from the search as well as the data presented and discussed during the Technical Consultation. The system used to establish the strength and ranking of the recommendations involved assessing each intervention on the basis of: (i) desirable and undesirable effects; (ii) quality of available evidence; (iii) values and preferences related to interventions in different settings; and (iv) cost of options available to health care workers in different settings. Scope of the guidelines The draft questions and list of outcomes related to the treatment of PPH and management of retained placenta were sent to 144 experts from all parts of the world. Responses were received from 60 of these experts: 46 physicians, 7 midwives, and 7 non-clinicians (policy-makers, researchers and consumers), representing all 6 WHO regions. There were 39 questions in 6 domains: ▪ ▪ ▪ assessment of blood loss (1 question); drugs for atonic PPH (13 questions); non-drug interventions for atonic PPH: – – – mechanical (6 questions); radiological (1 question); surgical (8 questions); ▪ ▪ ▪ retained placenta (4 questions); organizational and educational interventions (5 questions); crystalloid versus colloid fluids for resuscitation (1 question). This question was included following a suggestion from the respondents during the survey. The average scores for questions and outcomes are shown in Annex 1. It should be noted that not all outcomes are applicable to all questions. As mentioned above, questions that scored less than 7 are also included in the guidelines. Evidence and recommendations A. Diagnosis of PPH 1. Should blood loss be routinely quantified during management of the third stage of labour for the purpose of diagnosing PPH? Several related studies that looked at measurement of blood loss following childbirth, with the objective of ensuring timely diagnosis of PPH and improving health outcomes, were assessed. No study was found that directly addressed the question. Summary of evidence Visual versus quantitative methods for estimating blood loss after vaginal delivery One RCT (3) compared visual estimation of blood loss with measurement of blood collected in a plastic drape. Six observational studies (4–9), with a total of 594 participants, compared visual estimation with known values in the delivery room or in simulated scenarios. Three studies (10–12) compared visual or quantified estimations with laboratory measurement in 331 vaginal deliveries. In the RCT (3), visual estimation underestimated blood loss when compared with drape measurement (mean difference 99.71 ml) (page 27, GRADE Table A1). Visual methods underestimated blood loss when compared with known simulated volumes. Training courses on estimating blood loss after vaginal delivery One RCT (13) compared the accuracy of estimation of blood loss by 45 nurses attending a course on blood loss estimation and 45 nurses not attending the course. In this small RCT (13), with seven simulated scenarios, blood loss was accurately estimated by 75.55% of the nurses attending a training course compared with 24.44% without training (relative risk (RR) 3.09; 95% confidence interval (CI) 1.80–5.30) (page 27, GRADE Table A2). In three studies (14–16), a total of 486 staff members of maternity services visually estimated blood loss in simulated scenarios before and after training courses. The three uncontrolled studies (14–16) show results in the same direction as the RCT. Recommendation After childbirth, blood loss and other clinical parameters should be closely monitored. At present, there is insufficient evidence to recommend quantification of blood loss over clinical estimation. (Quality of evidence: low. Strength of recommendation: strong) Remarks The participants identified several priority research topics related to the definition and diagnosis of PPH. ▪ What quantity of blood loss should be the marker for diagnosis of PPH? ▪ Does the act of quantifying blood loss alter (or lead to improved) clinical outcomes for the mother and her baby? ▪ Which clinical consequences of blood loss are of greatest value for the diagnosis and treatment of PPH? B. Management of atonic PPH As a general preventive approach, the use of oxytocin for active management of the third stage of labour is strongly recommended, because it reduces PPH by more than 60% (17). 1. Medical interventions for management of PPH The Consultation was asked to assess the value of injectable uterotonics (oxytocin, ergometrine, fixed dose combination of oxytocin and ergometrine, carbetocin and injectable prostaglandin), misoprostol (tablet form used via oral, sublingual and rectal routes), injectable tranexamic acid and injectable recombinant factor VIIa in the management of PPH thought to be due to uterine atony. For oxytocin, ergometrine and prostaglandin F2α, the Consultation agreed with the doses recommended in the WHO guide, Managing complications in pregnancy and childbirth (18), as given in Table 1 (overleaf). The recommendations below may also be used in cases of PPH due to uterine atony following caesarean section. The Consultation acknowledged that these recommendations were based primarily on data following vaginal birth, and that specific data on PPH due to uterine atony following caesarean section were scarce and not evaluated separately from data on vaginal births. (a) Which uterotonics should be offered in the management of PPH due to uterine atony? Summary of evidence Except for the specific misoprostol trials evaluated in section (b), the evidence has been extrapolated from research on prevention of PPH. Systematic reviews comparing the effects of oxytocin with ergometrine (19), a fixed-dose combination of oxytocin and ergometrine (20), carbetocin (21) and prostaglandins (22) in the prevention of PPH were reviewed. The guidelines on prevention of postpartum haemorrhage published by WHO synthesized and graded the evidence and made recommendations (1). That publication includes the relevant GRADE tables. Separate GRADE tables were not prepared for this question and the evidence is summarized below narratively. One RCT comparing oxytocin to ergometrine in 600 women (23) was published subsequent to the systematic review and publication of the WHO guidelines. Table 1. Drug doses for management of PPH Oxytocin Ergometrine/ Methyl-ergometrine 15-Methyl prostaglandin F2a Dose and route IV: Infuse 20 units in 1 l IM or IV (slowly): 0.2 mg IV fluids at 60 drops per minute IM: 0.25 mg Continuing dose IV: Infuse 20 units in 1 l Repeat 0.2 mg IM after IV fluids at 40 drops per 15 minutes minute If required, give 0.2 mg IM or IV (slowly every 4 hours 0.25 mg every 15 minutes Maximum dose Not more than 3 l of IV fluids containing oxytocin 5 doses (Total 1.0 mg) 8 doses (Total 2 mg) Precautions/ contraindications Do not give as an IV bolus Pre-eclampsia, hypertension, heart disease Asthma Prostaglandin F2a should not be given intravenously. It may be fatal. Managing complications in pregnancy and childbirth. Geneva, World Health Organization, 2000, page S-28, table S–8. IV intravenous IM intramuscular Oxytocin vs ergometrine One trial (24) included in the systematic review reported on the critical outcomes of blood loss of >1000 ml and need for blood transfusion. There was no difference in incidence of blood loss >1000 ml (RR 1.09, 95%CI 0.45–2.66). Blood transfusion was given to 2 of 78 women receiving oxytocin compared with 1 of 146 women receiving ergometrine (RR 3.74, 95%CI 0.34–40.64). No significant difference was observed in the use of additional uterotonics in two trials in the systematic review (24, 25): in 35 of 557 women given oxytocin and 46 of 651 women given ergometrine (RR 1.02, 95% CI 0.67–1.55). In the later Nigerian trial (23), the use of additional uterotonics was reported in 18 of 297 patients receiving oxytocin in the third stage of labour compared with 30 of 303 receiving ergometrine (RR 0.61, 95%CI 0.35–1.07). The incidence of adverse side-effects was significantly lower in women receiving oxytocin than in those given ergometrine; for vomiting, the RR was 0.09 and the 95% CI 0.05–0.16); for elevated blood pressure, RR was 0.01 and 95% CI 0.00–0.15). Oxytocin-ergometrine fixed dose combination vs oxytocin With regard to blood loss >1000 ml, decreased blood loss was observed in the group given the fixed-dose combination of oxytocin (5 IU) and ergometrine (0.5 mg) although the difference was not statistically significant (Peto odds ratio (OR) 0.78, 95%CI 0.58–1.03). In four studies that reported on the use of blood transfusion, there was no significant difference and wide confidence interval compatible with either direction of effect (Peto OR 1.37, 95%CI 0.89–2.10). Three studies reported a slight, but statistically significant, lower use of additional uterotonics in the group receiving fixed dose oxytocin-ergometrine combination (RR 0.83, 95%CI 0.72–0.96). Four studies reported on the incidence of side-effects, notably a higher incidence of elevated diastolic blood pressure in the group given the oxytocin-ergometrine fixed dose combination (RR 2.40, 95%CI 1.58–3.64). Oxytocin-ergometrine fixed dose combination vs ergometrine None of the critical outcomes was addressed in the studies. Carbetocin vs oxytocin No data on blood loss ≥1000 ml, blood transfusion or surgical treatments were available. For the other priority outcomes, the use of additional uterotonics was similar in the two groups (RR 0.93, 95%CI 0.44–1.94), but there was less use of uterine massage in the carbetocin group (RR 0.70, 95% CI 0.51–0.94). Data on side-effects were too limited to allow any judgements to be made (nausea: RR 0.66, 95%CI 0.22–2.00; vomiting: RR 0.07, 95%CI 0.00–1.25; headache: RR 0.51, 95%CI 0.20–1.30). Carbetocin vs Oxytocin-ergometrine fixed dose combination Of 150 women given carbetocin and 150 given oxytocin-ergometrine fixed dose combination, only one woman given the combination experienced blood loss ≥1000 ml (26). Use of additional uterotonics was similar, with wide confidence intervals (RR 1.3, 95%CI 0.56–3.13), but the occurrence of side-effects was lower in the carbetocin group (nausea: RR 0.18, 95%CI 0.04–0.78; hypertension up to 60 minutes postpartum: RR 0.11, 95%CI 0.03–0.47). In a smaller observational study (27), fewer women in the carbetocin group had a blood loss of >1000 ml (1 of 55 given carbetocin and 9 of 62 given the combination (RR 0.12, 95%CI 0.15–0.94)). Intramuscular prostaglandins vs injectable uterotonics) No difference was observed in the risk of blood transfusion between these two treatments (RR 1.05, 95%CI 0.39–2.86). Use of additional uterotonics was not significantly different between the prostaglandin group (4 of 106) and the injectable uterotonic group (2 of 116) (RR 2.05, 95%CI 0.39–10.92). Vomiting was observed in 15 of 103 patients receiving prostaglandin and 1 of 107 patients receiving injectable uterotonics (RR 10.74, 95%CI 2.06–56.02). Sulprostone vs injectable uterotonics Two RCTs conducted in the Netherlands (28, 29) reported on estimated blood loss of ≥1000 ml. There was a nonsignificant reduction in the risk of severe PPH in both low-risk (28) and high-risk women (29) (RR 0.41, 95%CI 0.14–1.20) in women receiving sulprostone. The Van Selm study (29) was terminated early because of concerns regarding myocardial infarctions in women treated with sulprostone and mifepristone. Carboprost vs misoprostol No evidence was found relating to the priority outcomes regarding blood loss. Of 60 patients in the carboprost group, none received a blood transfusion compared with 1 of 60 in the misoprostol group (RR 0.33, 95%CI 0.01–8.02) (30). No patients in the carboprost group reported shivering, compared with 5 in the misoprostol group (RR 0.09, 95%CI 0.01–1.61). Misoprostol vs injectable uterotonics When compared with injectable uterotonics there was an increase in the risk of blood loss of ≥1000 ml in women receiving oral misoprostol (400–800 μg) (RR 1.32, 95%CI 1.16–1.51), but no statistically significant difference in the incidence of severe morbidity, including maternal death (RR 1.00, 95%CI 0.14–7.10). These trials did not report the outcome of invasive or surgical treatments. Recommendations ▪ For management of PPH, oxytocin should be preferred over ergometrine alone, a fixed-dose combination of ergometrine and oxytocin, carbetocin, and prostaglandins. (Quality of evidence: very low to low. Strength of recommendation: strong.) ▪ If oxytocin is not available, or if the bleeding does not respond to oxytocin, ergometrine or oxytocin-ergometrine fixed-dose combination should be offered as second-line treatment. (Quality of evidence: very low to low. Strength of recommendation: strong.) ▪ If the above second-line treatments are not available, or if the bleeding does not respond to the second-line treatment, a prostaglandin should be offered as the third line of treatment. (Quality of evidence: very low to low. Strength of recommendation: strong.) Remarks ▪ The above recommendations are based largely on data from prevention trials or case series. However, data from treatment RCTs were available for misoprostol versus oxytocin. ▪ The pharmacokinetics, bioavailability and mode of action of oxytocin and ergometrine and the uterotonic effects of misoprostol in other obstetric and gynaecological uses were considered by the participants in the Consultation in making the recommendations. ▪ Misoprostol may be considered as a third line of treatment for the management of PPH, because of its ease of administration and low cost compared with injectable prostaglandins (see also section (b)). ▪ The Consultation noted that the cost of carbetocin was high compared with the other options. Moreover, it found no evidence that carbetocin has a significant advantage over oxytocin. (b) Should misoprostol be offered in the management of PPH due to uterine atony? The Consultation made recommendations relating to two separate scenarios: women who received prophylactic oxytocin during the third stage of labour and those who did not. (i) Should misoprostol be offered for the management of PPH in women who have received prophylactic oxytocin during the third stage of labour? Summary of evidence Four trials assessed the use of misoprostol as an adjunct following active management of the third stage of labour with oxytocin (31–34). The three published trials (31–33) were relatively small, with a total of 465 women participating. The unpublished WHO-Gynuity trial (34) included 1400 women in Argentina, Egypt, South Africa, Thailand and Viet Nam. In three trials (31, 33, 34), 600 µg of misoprostol was administered orally or sublingually, while in the fourth trial (32) 1000 µg was administered orally, sublingually or rectally. The results of the WHO-Gynuity trial (34) were presented to the Consultation and are included in the GRADE table (page 28, GRADE Table B1). Taken altogether, when misoprostol as an adjunct was compared with placebo in women receiving other standard treatments, there were no statistical differences in the critical outcomes of additional blood loss ≥500 ml (RR 0.83, 95%CI 0.64–1.07), additional blood loss ≥1000 ml (RR 0.76, 95%CI 0.43–1.34) and blood transfusion (RR 0.96, 95%CI 0.77–1.19). Similarly, in the large WHO-Gynuity trial (34), the critical outcomes of additional blood loss ≥500 ml (RR 1.01, 95%CI 0.78–1.30), additional blood loss ≥1000 ml (RR 0.76, 95%CI 0.43–1.34) and blood transfusion (RR 0.89, 95%CI 0.69– 1.13) were not clinically or statistically significantly different in the two groups. Recommendation There is no added benefit of offering misoprostol as adjunct treatment for PPH in women who have received oxytocin during the third stage of labour. Where oxytocin is available, and is used in the management of the third stage of labour, oxytocin alone should be used in preference to adjunct misoprostol for the management of PPH. (Quality of evidence: moderate to high. Strength of recommendation: strong.) Remark The recommendation is based mainly on data from one large unpublished randomized controlled trial (34). (ii) Should misoprostol be offered as a treatment for PPH in women who did not receive prophylactic oxytocin during the third stage of labour? Summary of evidence The evidence relating to this question came from one large RCT conducted in Ecuador, Egypt and Viet Nam (35), which compared 800 µg of misoprostol given sublingually with 40 IU of oxytocin given intravenously. Unpublished trial results were presented to the Consultation (page 29, GRADE Table B2). Women who received misoprostol had a significantly increased risk of additional blood loss ≥500 ml (RR 2.66, 95%CI 1.62–4.38) and of needing additional therapeutic uterotonics (RR 1.79, 95%CI 1.19–2.69). There were few cases of additional blood loss ≥1000 ml (5 of 488 in the group given misoprostol and 3 of 489 given oxytocin). There was an increased risk of blood transfusion in the misoprostol group, of borderline statistical significance (RR 1.54, 95%CI 0.97–2.44). Regarding side-effects, 66 of 488 women receiving misoprostol had a body temperature above 40 °C, compared with none of 490 given oxytocin. Most of the cases of high temperature occurred in Ecuador, where 36% of the women given misoprostol had a temperature above 40 °C. There were no cases in Egypt. Seven of the women with high temperature had delirium.1 Recommendation In women who have not received oxytocin as a prophylactic during the third stage of labour, oxytocin alone should be offered as the drug of choice for the treatment of PPH. (Quality of evidence: moderate to high. Strength of recommendation: strong.) Remarks ▪ Evidence of the superiority of oxytocin over misoprostol for the treatment of PPH came from one large trial, which showed oxytocin to have higher effectiveness and fewer side-effects. ▪ The Consultation recognized that oxytocin may not be available in all settings. It encouraged health care decision-makers in these settings to strive to make oxytocin and other injectable uterotonics available. However, because the use of a uterotonic is essential for the treatment of PPH due to atony, it considered that misoprostol may be used until oxytocin can be made available. ▪ The Consultation noted that the doses of misoprostol used in the trials on prevention of PPH ranged from 200 µg to 800 µg, administered orally, sublingually or rectally. In the PPH treatment trials, doses from 600 µg to 1000 µg were administered orally, sublingually or rectally. Side-effects, primarily high fever and shivering, were associated with higher doses; few life-threatening events have been reported. Hence, doses of 1000–1200 µg are not recommended. The Consultation noted that the largest trial of misoprostol for treatment of PPH (35) reported use of a dose of 800 µg, given sublingually. The majority of the participants felt that, in the treatment of PPH, where the first- and secondline uterotonics are not available or have failed, as a last resort 800 μg can be used. However, three members strongly disagreed with this conclusion because 1 Final numbers were confirmed after the meeting by Gynuity. of concerns about safety. Because of the disagreement the discussion of dose is included here, rather than as a recommendation. ▪ In view of the uncertainty and disagreement among the participants regarding the safe dose of misoprostol, WHO will commission a further review of misoprostol doses and routes of administration. (c) Should tranexamic acid be offered in the treatment of PPH due to uterine atony? Tranexamic acid is an antifibrinolytic agent that has been on the market for several decades. Antifibrinolytic agents are widely used in surgery to reduce blood loss. A systematic review of randomized controlled trials of antifibrinolytic agents in elective surgery showed that tranexamic acid reduced the risk of blood transfusion by 39% (36). Another Cochrane review showed that tranexamic acid reduced heavy menstrual bleeding without side-effects (37). Summary of evidence There have been no RCTs on the use of tranexamic acid for the treatment of PPH following vaginal delivery that address the priority outcomes. Tranexamic acid has been evaluated as prophylaxis following caesarean section in one RCT (38). The average blood loss in the two hours after the caesarean section was 42.75±40.45 ml in the study group and 73.98±77.09 ml in the control group. One case report was found of a woman given tranexamic acid for treatment of massive postpartum haemorrhage after caesarean section (39). Recommendation Tranexamic acid may be offered as a treatment for PPH if: (i) administration of oxytocin, followed by second-line treatment options and prostaglandins, has failed to stop the bleeding; or (ii) it is thought that the bleeding may be partly due to trauma. (Quality of evidence: very low. Strength of recommendation: weak.) Remarks Evidence for this recommendation was extrapolated from the literature on surgery and trauma, which shows tranexamic acid to be a safe option in trauma-related bleeding. The benefits of use of tranexamic acid in PPH treatment should be investigated in research studies. (d) Should recombinant factor VIIa be offered in the treatment of PPH due to uterine atony? Recently, recombinant factor VIIa (rFVIIa) has generated interest as an option for treatment of PPH, mainly in industrialized countries. The evidence regarding its use in the treatment of PPH is limited to reviews of case reports and case series (40, 41) and two observational studies (42,43) (page 30, GRADE Table B3). Hossain (43) described a retrospective cohort study of 34 patients with more than 1500 ml blood loss in which 18 were treated with rFVIIa. Ahonen (42) compared the outcomes of 26 women who received rFVIIa to those of 22 women treated in the same time period for PPH without rFVIIa. Both studies included women who had had caesarean section as well as women who had had a vaginal birth. The causes of PPH included uterine atony as well as abnormal placentation, retained placenta, and cervical or vaginal lacerations. The women had received conventional treatments, such as uterotonics, uterine massage, arterial ligation and, in some cases, hysterectomy prior to the administration of rFVIIa. The risk of maternal death appeared to be lower in women treated with rFVIIa (OR 0.38, 95%CI 0.09–1.60), and remained lower following adjustment for baseline haemoglobin and activated partial thromboplastin time (aPTT) (OR 0.04, 95%CI 0.002– 0.83) (43). The risk of subsequent need for hysterectomy is difficult to ascertain, as the drug was administered as a ‘last resort’ treatment. The authors note that as confidence in its use increased, rFVIIa began to be offered prior to hysterectomy. In Ahonen’s report (42), 8 women received rFVIIa following hysterectomy, but none of the remaining 18 women treated with rFVIIa subsequently underwent hysterectomy. A high rate of thrombotic events (185 events in 165 treated patients) has been reported in patients receiving rFVIIa for off-label use (44). Ahonen (42) described one report of a pulmonary embolus; the woman was subsequently diagnosed with antithrombin deficiency. The Consultation discussed the evidence from observational studies and heard about ongoing research on rFVIIa. Recommendation The Consultation agreed that there was not enough evidence to make any recommendation regarding the use of recombinant factor VIIa for the treatment of PPH. Recombinant factor VIIa for the treatment of PPH should be limited to women with specific haematological indications. Remark Use of rFVIIa could be life-saving, but it is also associated with life-threatening sideeffects. Moreover, recombinant factor VIIa is expensive to buy and may be difficult to administer. 2. Non-medical interventions for management of PPH A range of mechanical interventions to compress or stretch the uterus have been proposed, either as temporizing measures or as definitive treatment. These interventions are summarized below. (a) Should uterine massage be offered in the treatment of PPH? Uterine massage as a therapeutic measure is defined as rubbing of the uterus manually over the abdomen sustained until bleeding stops or the uterus contracts. Initial rubbing of the uterus and expression of blood clots is not regarded as therapeutic uterine massage. Summary of evidence There have been no RCTs on the use of uterine massage in the treatment of PPH. A case report series (45) and indirect evidence from one systematic review (46) on the use of uterine massage in PPH prevention were found. In one RCT of the prophylactic use of uterine massage involving 200 women, massage was associated with a nonsignificant decrease in incidence of blood loss >500 ml (RR 0.52, 95%CI 0.16–1.67) and a significant reduction in the use of additional uterotonics (RR 0.20, 95%CI 0.08–0.50) (page 31, GRADE Table B4). Recommendation Uterine massage should be started once PPH has been diagnosed. (Quality of evidence: very low. Strength of recommendation: strong.) Remarks ▪ Uterine massage to ensure the uterus is contracted and there is no bleeding is a component of active management of the third stage of labour for the prevention of PPH. ▪ The low cost and safety of uterine massage were taken into account in making this recommendation strong. (b) Should bimanual uterine compression be offered in the treatment of PPH? Summary of evidence No RCTs on the use of bimanual uterine compression in the treatment of PPH were identified. One case report (47) was found. Recommendation Bimanual uterine compression may be offered as a temporizing measure in the treatment of PPH due to uterine atony after vaginal delivery. (Quality of evidence: very low. Strength of recommendation: weak.) Remark The Consultation noted that health care workers would need to be appropriately trained in the application of bimanual uterine compression and that the procedure may be painful. (c) Should uterine packing be offered in the treatment of PPH? Summary of evidence No RCTs on the use of uterine packing in the treatment of PPH were found. Seven case series and one case report (48–55), with a total of 89 women (the largest involved 33 women), and four overviews were identified. Success rates (i.e. no need for hysterectomy or other invasive procedure) ranging from 75% to 100% are reported in these studies. Recommendation Uterine packing is not recommended for the treatment of PPH due to uterine atony after vaginal delivery. (Quality of evidence: very low. Strength of recommendation: weak.) Remark The Consultation noted that there was no evidence of benefit of uterine packing and placed a high value on concerns regarding its potential harm. (d) Should intrauterine balloon or condom tamponade be offered in the treatment of PPH? Summary of evidence There have been no RCTs on the use of uterine tamponade in the treatment of PPH. Nine case series and twelve case reports, evaluating 97 women (56–76), and two reviews were identified (77, 78). The instruments used included SengstakenBlakemore and Foley catheters, Bakri and Rusch balloons, and condoms. Case series have reported success rates (i.e. no need for hysterectomy or other invasive procedure) ranging from 71% to 100%. Recommendation In women who have not responded to treatment with uterotonics, or if uterotonics are not available, intrauterine balloon or condom tamponade may be offered in the treatment of PPH due to uterine atony. (Quality of evidence: low. Strength of recommendation: weak.) Remark The Consultation noted that the application of this intervention requires training and that there are risks associated with the procedure, such as infection. The use of uterine balloon or condom tamponade in the treatment of PPH was considered a research priority. (e) Should external aortic compression be offered in the treatment of PPH? Summary of evidence No trials were found describing the use of external aortic compression in the treatment of PPH. A prospective study was performed in Australia to determine the haemodynamic effects of external aortic compression in nonbleeding postpartum women (79). Successful aortic compression, as documented by absent femoral pulse and unrecordable blood pressure in a lower limb, was achieved in 11 of 20 subjects. The authors concluded that the procedure is safe in healthy subjects and may be of benefit as a temporizing measure in treatment of PPH while resuscitation and management plans are made. Subsequently, one case report from Australia described the use of internal aortic compression as a temporizing measure to control severe PPH due to placenta percreta at the time of caesarean section (80). Recommendation External aortic compression for the treatment of PPH due to uterine atony after vaginal delivery may be offered as a temporizing measure until appropriate care is available. (Quality of evidence: very low. Strength of recommendation: weak.) Remarks ▪ External aortic compression has long been recommended as a potential life-saving technique, and mechanical compression of the aorta, if successful, slows down blood loss. ▪ The Consultation placed a high value on the procedure as a temporizing measure in treatment of PPH. (f) Should nonpneumatic antishock garments be offered in the treatment of PPH? Summary of evidence There have been no RCTs on the use of pneumatic or nonpneumatic antishock garments in the treatment of PPH. Case studies and case series have, however, been published and summarized (81–87). The use of nonpneumatic antishock garments (NASGs) has been reported in a before-and-after study of 634 women with obstetric haemorrhage (43% with uterine atony) in Egypt (88). Women treated with an NASG had a median blood loss 200 ml lower (range 300–100 ml lower) than women who received standard treatment (hydration with intravenous fluids, transfusion, uterotonics, vaginal or abdominal surgery, as needed) in the “before” period (i.e. before the introduction of NASG). The risk of blood transfusion was higher in those treated with NASG (RR 1.23, 95%CI 1.06–1.43); the risk of surgical procedures was not statistically significantly different (RR 1.35, 95%CI 0.90–2.02) (page 31, GRADE Table B5). A cluster RCT (Miller S, personal communication) is under way in Zambia and Zimbabwe to examine whether early application of an NASG by midwives prior to transfer to a referral hospital can decrease morbidity and mortality. No data were available for review. Recommendation The Consultation decided not to make a recommendation on this question. Remark The Consultation noted that research was ongoing to evaluate the potential benefits and harms of this intervention, and decided not to make a recommendation until these research results become available. (g) Should uterine artery embolization be offered in the treatment of PPH? Percutaneous transcatheter arterial embolization of the uterine artery has been reported from institutions that have adequate radiological facilities for this intervention. Summary of evidence There have been no RCTs on the use of arterial embolization in the treatment of PPH. One retrospective cohort study (89) compared 15 women treated with embolization with 14 women receiving other treatments for PPH. The majority of these patients had been transferred from local hospitals. Ten of 13 women were successfully treated for PPH with arterial embolization. Of 11 women originally treated with conservative surgical methods, two subsequently underwent arterial embolization; one of these was successful while the second patient eventually required hysterectomy. Eighteen case series and 15 case reports (90–122) have been published, describing the intervention in 340 women. Studies report success rates (i.e. no need for hysterectomy or other invasive procedures) ranging from 82% to 100% (page 32, GRADE Table B6). Recommendation If other measures have failed and resources are available, uterine artery embolization may be offered as a treatment for PPH due to uterine atony. (Quality of evidence: very low. Strength of recommendation: weak.) Remark Uterine artery embolization requires significant resources, in terms of cost of treatment, facilities and training of health care workers. 3. Surgical interventions in the treatment of PPH A wide range of surgical interventions have been reported to control postpartum haemorrhage that is unresponsive to medical or mechanical interventions. They include various forms of compression sutures, ligation of the uterine, ovarian or internal iliac artery, and subtotal or total hysterectomy. Summary of evidence There have been no RCTs on the use of uterine compressive sutures in the treatment of PPH. Thirteen case series and twelve case reports describing a total of 113 women were identified (123–147). Eight overviews on compression sutures have also been published (77, 78, 148–153). The B-Lynch technique seems to be the most commonly reported procedure. Success rates (i.e. no need for hysterectomy or other invasive procedure) range from 89% to 100%. Similarly, no RCTs on the use of selective artery ligation in treatment of PPH were identified. Twenty-one case series and 13 case reports have been published, describing the intervention in 532 women (123, 154–186). Studies report success rates (i.e. no need for hysterectomy or other invasive procedure) ranging from 62% to 100%. Recommendation If bleeding does not stop in spite of treatment with uterotonics, other conservative interventions (e.g. uterine massage), and external or internal pressure on the uterus, surgical interventions should be initiated. Conservative approaches should be tried first, followed – if these do not work – by more invasive procedures. For example, compression sutures may be attempted first and, if that intervention fails, uterine, utero-ovarian and hypogastric vessel ligation may be tried. If life-threatening bleeding continues even after ligation, subtotal (also called supracervical or total hysterectomy) should be performed. (Quality of evidence: no formal scientific evidence of benefit or harm. Strength of recommendation: strong.) Remark The Consultation acknowledged that the level of skill of the health care providers will play a role in the selection and sequence of the surgical interventions. C. Management of retained placenta 1. Should uterotonics be offered as treatment for retained placenta? Summary of evidence One double-blind RCT was found that compared sulprostone with placebo in 50 women with retained placenta (187). Originally designed to recruit over 100 patients, the trial was stopped prematurely and sulprostone was given to all remaining cases. The authors reported a lower risk of manual removal of the placenta (RR 0.51, 95%CI 0.34–0.86) and a similar risk of blood transfusion in the two groups (RR 0.81, 95%CI 0.33–2.00) (page 33, GRADE Table C1). There is no empirical evidence for or against the use of other uterotonics for treatment of retained placenta. Recommendations ▪ If the placenta is not expelled spontaneously, clinicians may offer 10 IU of oxytocin in combination with controlled cord traction. (No formal scientific evidence of benefit or harm. Strength of recommendation: weak.) ▪ Ergometrine is not recommended, as it may cause tetanic uterine contractions, which may delay expulsion of the placenta. (Quality of evidence: very low. Strength of recommendation: weak.) ▪ The use of prostaglandin E2 (dinoprostone or sulprostone) is not recommended. (Quality of evidence: very low. Strength of recommendation: strong.) Remarks ▪ The Consultation found no empirical evidence to support recommendation of uterotonics for the management of retained placenta in the absence of haemorrhage. The above recommendation was reached by consensus. ▪ The WHO guide, Managing complications in pregnancy and childbirth (18), states that if the placenta is not expelled within 30 minutes after delivery of the baby, the woman should be diagnosed as having retained placenta. Since there is no evidence for or against this definition, the delay used to diagnose this condition is left to the judgement of the clinician. ▪ The same guide also recommends that, in the absence of haemorrhage, the woman should be observed for a further 30 minutes following the initial 30 minutes, before manual removal of the placenta is attempted. The Consultation noted that, in the absence of bleeding, spontaneous expulsion of the placenta can still occur; thus, a conservative approach is advised and the timing of manual removal as the definitive treatment is left to the judgement of the clinician. ▪ The recommendation about prostaglandin E2 is based on the lack of evidence, as well as concerns regarding adverse events, notably cardiac events. 2. Should intra-umbilical vein injection of oxytocin with or without saline be offered as treatment for retained placenta? Summary of evidence One systematic review on umbilical vein injection for the management of retained placenta has been published (188). RCTs comparing the use of intraumbilical vein injection of saline with expectant management (four studies, 413 women), intraumbilical vein injection of saline+oxytocin with expectant management (five studies, 454 women), and intraumbilical vein injection of saline+oxytocin with saline (ten studies, 649 women) were identified. The results of one unpublished study (189) were made available to the Consultation by the investigators. In this multicentre trial, 577 women in Pakistan, Uganda and the United Kingdom were randomized to receive either intraumbilical vein injection of 50 IU of oxytocin in 30 ml of saline (n=292) or matching placebo (n=285). Intraumbilical vein injection of saline versus expectant management There were no significant differences in rates of manual removal of the placenta (RR 0.97, 95%CI 0.83–1.19), blood loss ≥500 ml (RR 1.04, 95%CI 0.55–1.96), blood loss ≥1000 ml (RR 0.73, 95%CI 0.17–3.11), or blood transfusion (RR 0.76, 95%CI 0.41–1.39) (page 34, GRADE Table C2). Intraumbilical vein injection of saline+oxytocin versus expectant management There was a slightly lower rate of manual removal of the placenta in the group given saline+oxytocin, although the difference was not statistically significant (RR 0.86, 95%CI 0.72–1.01). Rates of blood loss ≥500 ml (RR 1.53, 95%CI 0.78–2.67), blood loss ≥1000 ml (RR 1.29, 95%CI 0.38–4.34), and blood transfusion (RR 0.89, 95%CI 0.5–1.58) were similar with wide confidence intervals (page 35, GRADE Table C3). Intraumbilical vein injection of saline+oxytocin versus saline There was a lower risk of manual removal of the placenta in the group given saline+oxytocin (RR 0.79, 95%CI 0.69–0.91). No differences were found in rates of blood loss ≥500 ml (RR 1.43, 95%CI 0.83–2.45), blood loss ≥1000 ml (RR 1.71, 95%CI 0.45–6.56) or blood transfusion (RR 1.17, 95%CI 0.63–2.19) and the confidence intervals were wide because there were few events (page 36, GRADE Table C4). The unpublished RELEASE trial (189) data showed no benefit of intraumbilical vein injection of saline with oxytocin over placebo in terms of manual removal of the placenta (RR 0.98, 95%CI 0.87–1.12), blood loss ≥500 ml (RR 0.98, 95%CI 0.78–1.23), blood loss ≥1000 ml (RR 1.09, 95%CI 0.67–1.76) and blood transfusion (RR 0.77, 95%CI 0.46–1.26) (page 37, GRADE Table C5). Recommendations ▪ Intraumbilical vein injection of oxytocin with saline may be offered for the management of retained placenta. (Quality of evidence: moderate. Strength of recommendation: weak.) ▪ If, in spite of controlled cord traction, administration of uterotonics and intraumbilical vein injection of oxytocin+saline, the placenta is not delivered, manual extraction of the placenta should be offered as the definitive treatment. (No formal assessment of quality of evidence. Strength of recommendation: strong.) Remarks ▪ During the discussion on this topic, a new meta-analysis of the available data was performed, by including data from the recent large unpublished study with the existing published meta-analysis. Sensitivity analyses by quality of data and a fixed-versus-random-effects analysis were also conducted. In all these secondary analyses, the summary estimate reflected a modest effect, with the relative risk of manual removal being 0.89 (95%CI 0.81–0.98) with a fixed-effect model and 0.82 (95%CI 0.68–0.98) with a random-effect model. The Consultation was concerned about the possibility of publication bias in the meta-analysis, and was split between making a weak recommendation and not recommending intra-umbilical vein injection of oxytocin+saline. ▪ The Consultation recommended by a majority the use of umbilical vein injection of oxytocin+saline for retained placenta. In making the recommendation, the Consultation considered the advantages of avoiding an invasive intervention, such as manual removal of the placenta, and the low cost and absence of any sideeffects with umbilical vein injection. It was noted that a potential disadvantage was that this intervention may delay the administration of other effective interventions. These considerations should be taken into account in the local adaptation of these guidelines. 3. Should antibiotics be offered after manual extraction of the placenta as part of the treatment of retained placenta? Summary of evidence A systematic review of antibiotic prophylaxis after manual removal of the placenta, published in 2006, found no RCTs (190). One retrospective study (191) of 550 patients evaluated prophylactic antibiotic therapy in intrauterine manipulations (such as forceps delivery, manual removal of the placenta and exploration of the cavity of the uterus) during vaginal delivery. Recommendation A single dose of antibiotics (ampicillin or first-generation cephalosporin) should be offered after manual removal of the placenta. (Quality of evidence: very low. Strength of recommendation: strong.) Remarks ▪ Direct evidence of the value of antibiotic prophylaxis after manual removal of the placenta was not available. The Consultation considered indirect evidence of the benefit of prophylactic antibiotics from studies of caesarean section (192) and abortion, and observational studies of other intrauterine manipulations. ▪ Current practice suggests that ampicillin or first-generation cephalosporin may be administered when manual removal of the placenta is performed. ▪ This question was identified as a research priority for settings in which prophylactic antibiotics are not routinely administered and those with low infectious morbidity. D. Choice of fluid for replacement or resuscitation 1. Should crystalloids be offered for fluid replacement in women with PPH? Fluid replacement is an important component of resuscitation for women with PPH, but the choice of fluid is controversial. Although outside the initial scope of these guidelines, this question was put to the Consultation in view of its importance. Summary of evidence There have been no RCTs comparing the use of colloids with other replacement fluids for resuscitation of women with PPH. There is indirect evidence from a Cochrane review that evaluated 63 trials on the use of colloids in the resuscitation of critically ill patients who required volume replacement secondary to trauma, burns, surgery, sepsis and other critical conditions (193). A total of 55 trials reported data on mortality for the following comparisons. Colloids versus crystalloids No statistical difference in the incidence of mortality was found when albumin or plasma protein fraction (23 trials, 7754 patients, RR 1.01, 95%CI 0.92–1.10), hydroxyethyl starch (16 trials, 637 patients, RR 1.05, 95%CI 0.63–1.75), modified gelatin (11 trials, 506 patients, RR 0.91, 95%CI 0.49–1.72), or dextran (nine trials, 834 patients, RR 1.24, 95%CI 0.94–1.65) were compared with crystalloids (page 38, GRADE Table D1). Colloid versus hypertonic crystalloid One trial, which compared albumin or plasma protein fraction with hypertonic crystalloid, reported one death in the colloid group (RR 7.00, 95%CI 0.39–126.92). Two trials that compared hydroxyethyl starch and modified gelatin with crystalloids observed no deaths among the 16 and 20 participants, respectively (page 39, GRADE Table D2). Colloids in hypertonic crystalloid versus isotonic crystalloid The outcome of death was reported in eight trials, including 1283 patients, which compared dextran in hypertonic crystalloid with isotonic crystalloid (RR 0.88, 95%CI 0.74–1.05) and in one trial with 14 patients (page 39, GRADE Table D3). Recommendation Intravenous fluid replacement with isotonic crystalloids should be used in preference to colloids for resuscitation of women with PPH. (Quality of evidence: low. Strength of recommendation: strong.) Remark Available evidence suggests that high doses of colloids, which are more expensive than isotonic crystalloids, may cause adverse effects. E. Health systems and organizational interventions 1. Should health care facilities have a protocol for management of PPH? Summary of evidence The literature search did not reveal any research evidence for or against the use of PPH management protocols. Although no systematic review was carried out, the Consultation considered that management protocols are generally useful and unlikely to be harmful. Recommendation Health care facilities should adopt a formal protocol for the management of PPH. (Quality of evidence: no formal evidence reviewed; consensus. Strength: strong.) Remark The Consultation acknowledged that the implementation of formal protocols is a complex process, which will require local adaptation of general guidelines. 2. Should health care facilities have a formal protocol for referral of women diagnosed as having PPH? Summary of evidence The literature search did not reveal any research evidence for or against the use of PPH referral protocols. Although no systematic review was carried out, the Consultation considered that referral protocols are generally useful and unlikely to be harmful. Recommendation Health care facilities should adopt a formal protocol for patient referral to a higher level of care. (Quality of evidence: no formal evidence reviewed; consensus. Strength of recommendation: strong.) 3. Should simulation of PPH treatment be part of training programmes for health care providers? Summary of evidence The literature search did not reveal any research evidence for or against the use of PPH simulation programmes. Although no systematic review was carried out, the Consultation considered that PPH simulation programmes are generally useful and unlikely to be harmful. Recommendation Simulations of PPH treatment may be included in pre-service and in-service training programmes. (Quality of evidence: no formal evidence reviewed; consensus. Strength of recommendation: weak.) Remarks This recommendation is extrapolated from non-obstetric literature. The Consultation placed a high value on the costs of simulation programmes acknowledging that there are different types of simulation programmes. Some of those programmes are hi-tech, computerized and costly while others are less expensive and more likely to be affordable in low and middle income countries. The Consultation identified improvement in communication between health care providers and patients and their family members as an important priority in training of health care providers in PPH management. The Consultation identified this area as a research priority. PPH care pathways Postpartum haemorrhage can present in different clinical scenarios. Bleeding may be immediate and in large amounts, it may be slow and unresponsive to treatments, or it may be associated with systemic problems, such as clotting disorders. The recommendations related to PPH prevention, namely, active management of the third stage of labour, should be routinely applied (1). It is critical that health workers remain vigilant during the minutes and hours following birth, in order to identify problems quickly. The care pathways presented (see insert) assume the presence of a skilled caregiver and a facility with basic surgical capacity. A stepwise approach is recommended. The initial step is to assess the woman and take immediate nonspecific life-saving measures, such as resuscitation, calling for help and monitoring vital signs. The second step is to give directive therapy following the diagnosis of PPH. In a given clinical situation, not all diagnostic assessments can be done simultaneously. The caregiver should assess the situation according to the circumstances surrounding the birth and immediate subsequent events. First trimester abortion The duration of pregnancy (gestation duration) is conventionally divided into three trimesters: first trimester, up to 14 weeks of gestation since the first day of the last menstrual period; second trimester, 14–28 weeks; third trimester, 28 weeks to delivery (at 40 weeks, on average).4 First trimester surgical abortion (up to 12 or 14 weeks) and medical abortion (up to nine weeks) should be performed as outpatient procedures. Pre-abortion visit Clinical aspects Counselling History taking As outlined in the Introduction, counselling must be Take a note of the following: supportive and empathetic. If the client is accompanied, • The woman’s age. make sure that some counselling time is set aside for the • Her marital status (if necessary; not mandatory). client alone. Involve the accompanying person later and also • Previous pregnancies (children and their health, provide information to him or her on caring for the client. If the woman agrees, explore the following issues: • Is she seeking to continue the pregnancy, to have the baby adopted or to have an abortion? • What support is available if she decides to continue the pregnancy or to opt for adoption? • Is she being coerced into seeking an abortion? • The legal aspects of abortion, and the need to sign an informed consent form. • Her reasons for seeking an abortion, including her miscarriage(s), ectopic pregnancy, induced abortions), as well as all types of complications during previous pregnancies. • Duration of current pregnancy (since the first day of last menstrual period). Confirm with clinical examination. See General physical examination on page 7 and Gynaecological examination on page 7. • Any attempt to abort current pregnancy (and details, if relevant). • Past and present medical and surgical (especially socio-cultural and economic circumstances. This is, abdominal) conditions that might affect an abortion however, not mandatory, so only explore these reasons procedure, for example a bleeding disorder, reproductive if the discussion goes in this direction. Many women do tract infections, allergies (to anaesthetics, antibiotics not want to address these issues, and their wishes must or other), medication taken, and contraception used, be respected. If there are indications of violence, be ready correctly or otherwise. to provide referrals for further support. • Levels of anxiety and guilt. • Support (or absence of support) from partner/friends/ family. • The possibility of sexual abuse or gender-based violence. • The various options (if relevant) of abortion techniques and pain control. • Previous female genital mutilation: this could complicate the procedures. • Past experience with contraceptive methods and future contraception being considered. • If the pregnancy is not established, ask if symptoms of early pregnancy are present: breast tenderness and engorgement, nausea, fatigue, frequent urination and/or changes in appetite. 4 Subtract two weeks from these timings if calculating from the day of presumed or proven ovulation. Chapter 2 First trimester abortion Clinical assessment • A uterus bigger than expected suggests multiple a) General physical examination pregnancy (polycyesis: more than one foetus), molar Check or examine: pregnancy or fibroids. • General health (pulse, blood pressure, heart, lungs and • A uterus smaller than expected suggests a miscarriage, no temperature). Check for anaemia, malnutrition and other pregnancy or ectopic pregnancy. If pregnancy is suspected signs of ill health. Refer if necessary to a higher level and the uterus is still small six weeks after the last provider for a pre-abortion medical assessment. menstrual period, use ultrasound for checking, or hCG, • Abdomen (ask the woman to empty her bladder beforehand). Is it distended? Are there masses? Can the uterus be felt? If so, assess its size. or refer. In the case of ectopic pregnancy, take immediate action by medical or surgical treatment, applying local guidelines, or refer immediately. • Determine the position of the uterus (ante- or retroflexed; b) Gynaecological examination Pelvic examination and speculum ante- or retroverted). • Check for reproductive tract infections (uterine, • Ask the woman to empty her bladder beforehand. tubo-ovarian), sexually transmitted infections and cystitis. • Ensure privacy and, where customary, the presence of a If antibiotics are indicated, start immediately, female chaperone if the provider is male. • Ensure adequate light. • Speak kindly to the woman; explain the procedures and BEFORE the abortion, but do not delay the abortion once the antibiotics have been started. • Record all the findings in the client’s file. help her relax. • Wash hands and use sterile or disinfected gloves; proceed gently. • Inspect the perineal area, and check for signs of sexually transmitted infections: ulcers, condyloma, discharge. c) Special investigations Ultrasound and laboratory testing are special procedures, but their availability should not be a prerequisite for the provision of abortion services. See Annex 1 for details. Check for vulvitis, female genital mutilation and scars. Swab the vulva. Treat as needed. • Gently insert a closed speculum, of the smallest effective Prophylactic (preventive) antibiotics Most, but not all protocols for comprehensive abortion size, moistened with warm water (gels and lubricants care recommend the routine administration of prophylactic interfere with diagnostic accuracy for sexually transmitted antibiotics. Follow local guidelines. World Health infections). Avoid pressure on the urethra. Check for, Organization5 and IPPF guidance6 state that this reduces diagnose and treat vaginal and cervical infections, the post-procedural risk of infection, but that abortion according to local protocols. should not be denied where prophylactic antibiotics are not • If indicated and available, perform cervical cytology or available. inspection (not a precondition to provide the abortion). Counselling: contraception, follow-up, questions and answers Bimanual pelvic examination a) Contraception • Wash hands and use sterile or disinfected gloves; proceed A wide choice of contraceptive methods should be made gently. available, including sterilization (if relevant, although hasty • Confirm pregnancy (soft cervix; enlarged, soft uterus). decisions should not be made). Ensure that contraceptive • Check that the size of the uterus corresponds to the information relating to the available options is made gestation duration. A discrepancy may be due to an available before the procedure, before leaving the clinic error in the calculation, or indicate a problem with the on the day of the procedure, and during subsequent pregnancy. post-abortion visit(s), but not during the procedure itself when the woman is under emotional or physical stress. 5 World Health Organization (2003) Safe Abortion: Technical and Policy Guidance for Health Systems, www.who.int/reproductive-health/publications/ safe_abortion/safe_abortion.pdf 6 International Planned Parenthood Federation (2004) IPPF Medical and Service Delivery Guidelines for Sexual and Reproductive Health Services, www.ippf.org 7 Chapter 2 First trimester abortion Acceptance of contraception or of a particular method must Surgical or medical abortion? never be a prerequisite for the provision of abortion-related First trimester abortion can be provided using either medical services. See Chapter 5 for information about post-abortion drug-induced abortion, up to nine weeks, or surgical contraception. techniques. Both can be provided by trained mid-level staff (nurses, midwives and medical assistants, according to the b) Explaining the procedure and the follow-up defined scopes of practice at the national level). Table 1 Address the following issues: how long the procedure will summarizes the advantages and disadvantages of the two take; the possible side-effects (for example pain, bleeding, approaches. If both options are suitable, the patient’s choice nausea, diarrhoea, vomiting); the recovery time; possible should be respected. complications and where to go for treatment; safety aspects Surgical abortion can be performed by aspiration (using and the risks (all medical interventions carry some risks); the an electric pump or a manual syringe) or by dilatation and choice of anaesthesia and options for pain management; curettage (sometimes called dilation and curettage or D&C). and when to resume normal activities (including sexual Dilatation and curettage is an outdated surgical technique intercourse). Stress the need for contraception and condom that should be replaced, whenever possible, by aspiration or use, the need for follow-up and explain the content of the medical (drug-induced) abortion which are better options, as follow-up visit. recommended by the World Health Organization and IPPF.7 A surgical technique (preferably aspiration) should be c) Questions and answers used if: Allow sufficient time for the client to ask questions and • it is the woman’s choice express any fears. • concurrent sterilization is anticipated • there are contraindications to medical abortion • a client is unable to come for follow-up after a medical abortion as required Table 1: Advantages and disadvantages of medical and surgical abortion Advantages Medical abortion Surgical abortion • Avoids surgery and anaesthesia • Quicker • More ‘natural’, like menses • More likely to have a complete abortion • Emotionally easier for some women • Emotionally easier for some women • Client controlled; more privacy and autonomy; can be home-based • Better than surgical in very early gestation, or with • Takes place in a health care centre, clinic or hospital • Can be used up to 14 weeks (12–14 weeks by experts only) • Sterilization can be concurrent 8 severe obesity (body mass index >30) without other cardiovascular risk factors, or in the case of fibroids, uterine malformations or previous cervical surgery • No risk of cervical/uterine injury Disadvantages • Bleeding, cramping, nausea, diarrhoea and other side-effects • Invasive • Small risk of cervical or uterine injury • Waiting, uncertainty • Risk of infection • More clinic visits • Less privacy and autonomy • Drugs are costly • Can be costly • Can only be used up to nine weeks 7 See notes 5 and 6 on page 7. 8 Concurrent sterilization should never be done without the patient’s informed consent, and never hastily without proper thought beforehand. 7 Chapter 2 First trimester abortion Surgical abortion epinephrine) beneath the cervical mucosa at 2, 4, 8 and Preparation 10 o’clock around the cervix (be careful not to inject into a • Ensure that the consent form has been signed. blood vessel). The World Health Organization provides a full • Ensure that the equipment is in working order. description of the procedure.9 • Double check that the resuscitation equipment is in working order. Signs of a toxic reaction and its treatment are described in Table 2. Light (or conscious) sedation: This can replace the Pain control (and its possible complications) paracervical block. The procedure alters a woman’s state Pain may result from cervix dilatation, internal cervical of consciousness, without the risks associated with general os stimulation, uterus mobilization, scraping the uterine anaesthesia, helping her to feel more relaxed and less walls and reactive uterine muscular contractions. Intense anxious during the abortion. The patient breathes normally pain can result from cervical dilatation that is too forceful and is easily roused. She can respond to physical stimuli and or from intervention too soon after paracervical block. verbal commands. Pain thresholds vary; and fear and anxiety can augment pain. Providers should be calm, efficient, friendly and The management of anaesthesia-related adverse effects and possible complications is presented in Table 2. non-judgemental, and explain what is happening (or what General anaesthesia is not recommended because the client should expect to experience) all the way through narcosis adds risks. It can, however, be used on demand the procedure. Communication with the client should be or in abortion procedures that are difficult, medically or maintained at all times. emotionally. Skilled staff and the capacity to manage Supportive verbal communication is also required during complications are essential. the procedure. Where possible, and preferably, a supportive person should accompany the patient throughout the Cervical dilatation (or ‘cervical priming’) procedure. Counselling, empathy, ‘verbal anaesthesia’ and • Cervical priming is a pre-intervention dilatation of the fear reduction can all help, but pain control measures must cervix, making aspiration (or dilatation and curettage) always be available and provided. The following methods easier and quicker, and reducing the risk of cervical can be used singly or in combination. It should be noted laceration and, to a lesser degree, the risk of uterine that even if pain-relieving methods are used, including verbal perforation. anaesthesia, it is impossible to suppress pain totally. Analgesia: Analgesics such as paracetamol • Routine cervical preparation remains controversial because the advantages have been insufficiently proven. Some (acetaminophen) and ibuprofen ease pain. Opiates should providers use priming only in specific circumstances, be used with caution as post-abortion incidents have been such as late first trimester abortions at 12–14 weeks of described, such as falls on stairs and road accidents. To avoid pregnancy, adolescents and young women, nulliparity, this, the patient should be accompanied by someone who scarred or diseased cervix, perceived risk of cervical injury can try to avoid any problems and deal with any incident that may arise. Tranquillizers (anxiolytics): These reduce anxiety and memory, but not pain, and relax the muscles. When using benzodiazepines, such as diazepam, the same advice as for opiates (see paragraph above) should be followed. Paracervical block: This is always required for surgical or uterine perforation, or inexperienced provider. • Dilatation and curettage can sometimes be performed without any cervical dilatation, if it is very easy to pass the cannula through the inner cervical os. • Cervical priming is done using laminaria tents (Dilapan-S™ and Lamicel®, osmotic hydrophilic dilators) introduced into the cervical canal, or a prostaglandin abortion, unless the patient formally refuses it. Use a local (for example misoprostol) or mifepristone. Compared to anaesthetic such as lidocaine (lignocaine or xylocaine). laminaria, vaginal misoprostol acts faster, is associated Ensure there is no known allergy to lidocaine. Inject four with less discomfort and is preferred by patients. doses of 5mL (total 20mL) of 0.5 per cent lidocaine (without Sublingual misoprostol (400µg), at least two hours before 9 World Health Organization (2003) Managing Complications in Pregnancy and Childbirth: A Guide for Midwives and Doctors, www.who.int/reproductive-health/impac/Procedures/Paracervical_block_P1_P2.html 9 Chapter 2 First trimester abortion Table 2: Pain control in first trimester induced abortion: possible adverse effects and their treatment Type of intervention Verbal anaesthesia Measures Possible adverse effects, complications and management • Throughout the procedure, explain each step in simple • Some patients prefer silence language before it is performed • Medical assistant talks softly and reassuringly to patient • Avoid saying “this won’t hurt” or “it’s almost done” (when it is not) • Do not restrict pain medication • Ask patient to breathe slowly in through her nose and out through her mouth to help her focus more on breathing than on pain • Have a relaxing picture painted on the ceiling, to focus on; soft music can help (if the patient wants it) Oral analgesia • Use paracetamol 500–1,000mg or ibuprofen • Do not use aspirin which increases bleeding 400–800mg • Wait 30–60 minutes for it to take effect • Tramadol 50mg, an opiate, should be avoided or used with caution Anxiolysis • Diazepam 5–10mg orally • Dizziness: after the procedure, the patient should be accompanied at all times until the symptom wears off, and refrain from using stairs, driving, handling machinery, walking long distances Local anaesthesia: paracervical block with lidocaine • The provider must be trained to administer paracervical • Toxic reaction (rare): avoid by using the smallest effective block • Ensure there is no allergy to local anaesthesia • Lidocaine 1 per cent without epinephrine, limited to 3.5mg/kg body weight and, in any event, to a maximum of 20mL dose; aspirate before each injection • Mild reaction (numbness of tongue and lips; metallic taste in mouth; dizziness or light-headedness; ringing in ears, difficulty in focusing eyes): wait and support verbally • Severe reaction (sleepiness, slurred speech, disorientation, • Aspirate before injecting lidocaine muscle twitching, convulsions, loss of consciousness, respiratory • Wait 4–5 minutes for it to take effect depression): oxygen, diazepam 5mg IV, slowly; allergy (hives, rash): diphenhydramine 25–50mg IV • Respiratory distress: Ambu bag, oxygen, epinephrine 0.4mg (1:1000 solution) SC IV analgesia (by specialist only) • Fentanyl 0.05–0.06mg plus midazolam 0.5–1mg • Narcotics (and IV diazepam) can depress or even halt respiration; assist respiration with Ambu bag and oxygen. Reverse opiate analgesics with naloxone 0.4mg IV (a second dose might be necessary). Reverse diazepam with flumazenil 0.2mg IV 10 Chapter 2 First trimester abortion the procedure, is effective. Oral administration is also Manual vacuum aspiration procedure effective, but higher doses and longer treatment periods • Reassess the size, position (‘version’) and flexion of the (8–12 hours) are required. Vaginal administration (400µg) results in the same dilatation (mean: 8.5mm) as oral administration with fewer side-effects (nausea, vomiting, uterus by bimanual examination. • Prepare two syringes (in case one is defective; discard if it does not hold a vacuum). diarrhoea and chills after vaginal misoprostol are 10, • Prepare several cannulas according to uterine size (inspect 8, 18 and 4 times lower, respectively, than after oral and discard if there are cracks or defects or any signs of misoprostol). Oral mifepristone (600mg) is also effective in cervical priming when administered 48 hours before weakness or wear). • Ask the patient, if conscious, to relax. Insert a comfortably a first trimester abortion. However, the cost is high and warm sterile speculum of the smallest adequate size into availability low, in comparison with misoprostol. the vagina. • Misoprostol or mifepristone can be self-administered. • Carefully spread the labia with a gloved hand; slowly insert the speculum blades downward and inward. Slowly Vacuum aspiration open the blades, letting the cervix appear between them. Vacuum aspiration is a very safe, effective procedure which • Using a sponge forceps, wipe the cervix three times, in should, whenever possible, replace dilatation and curettage. a circular outward movement, using a compress with It is used up to 12 weeks from last menstrual period. Expert antiseptic. providers can use it up to 14 weeks. Aspiration is more than • Grasp the cervix with the tenaculum that has been placed 99.5 per cent effective. The incidence of haemorrhage, pelvic for injecting the paracervical block, or place a forceps infection, cervical injury and uterine perforation is lower than at the 6 or 12 o’clock position. Straighten the uterus by with dilatation and curettage, and less cervical dilatation is exerting gentle traction on the tenaculum or the forceps necessary. The costs of the procedure, the staff time and resources needed are lower. No operating theatre or general anaesthesia is needed. placed on the cervix. • Hysterometry: gently insert a uterine sound (hysterometer) bent to the estimated angle of the uterine flexion, until resistance is met. Read the depth of the uterine cavity by Manual vacuum aspiration noting the level of the mucous or blood on the sound. Manual vacuum aspiration requires a single or double valve Make a mental note of the depth of the uterine cavity. syringe: the vacuum (at least 55mmHg) is generated by a Note that according to most practitioners and 60mL hand-held syringe which accommodates flexible plastic research results, this step is not only unnecessary but cannulas ranging from 4mm to at least 12mm in diameter. A may also be dangerous because it carries a risk of chart explaining the use of the syringe can be downloaded perforation. from Ipas.10 Infection prevention procedures and procedures for the • Gently try to insert the cannula (without cervical dilatation if the passage is very easy, which is usually the case up to reuse of manual vacuum aspiration instruments can be six weeks since last menstrual period). Carefully note the downloaded from Pathfinder International.11 position and flexion of the uterus. Do not use force to The first visit (see Pre-abortion visit on page 6), the pain control techniques (see Pain control on page 9) and the cervical priming techniques (see Cervical dilatation on page 9) are the same as for dilatation and curettage and are described earlier. dilate the cervix. • If there is resistance in the passage, use dilators to open the cervix gradually. • Once the cannula is inserted, use slow, gentle back and forth movements, and do not use excessive force (to avoid a perforation). Aspirate all tissues. There should Electric vacuum aspiration be no scraping of the uterine walls: the endometrium This uses an electric pump. The technique is fundamentally detaches under the influence of the negative pressure. the same as with manual vacuum aspiration. • When the uterus is empty, a strong uterine contraction 10 Ipas (2005) Tips for Using the Ipas MVA Plus, http://ipas.org/Library/Other/Tips_for_Using_the_Ipas_MVA_Plus.pdf 11 Pathfinder International (2000) Module 11: MVA for Treatment of Incomplete Abortion, pp73–99, www.pathfind.org/pf/pubs/module11.pdf 11 Chapter 2 First trimester abortion Table 3: Uterine size and corresponding cannula size to be used for manual vacuum aspiration Approximate uterine size (expressed as corresponding gestation duration) Approximate cannula size 5–6 weeks since day 1 of last menstrual period 5–6mm 7–8 weeks since day 1 of last menstrual period 7mm 9–10 weeks since day 1 of last menstrual period 7–10mm 10–12 weeks since day 1 of last menstrual period 9–12mm can be felt as the uterus grips the cannula, making the • After sedation or general anaesthesia, observe until aspiration more difficult. Bubbles and red foam appear in the patient’s full recovery. Discharge after anaesthetist’s the cannula. The provider can detect a rough sensation in authorization. the uterus. These signs indicate that the uterus is empty and that the procedure is complete. The last contents of the aspirate may be only a few drops of pure blood. When the uterus is empty, first stop aspirating, and only then remove the cannula. No additional curettage or • Record pain. Excessive pain could signal uterine perforation or acute haematometra (blood filling the uterus). See Table 4. • Ensure the woman is able to pass urine before she is discharged. ‘verification with curette’ is needed. • The products of conception must be examined by the Instructions to provide (verbal and written) and counselling provider or medical assistant: • How to use medications, if relevant. – to ensure complete evacuation; if incomplete, repeat • Some light bleeding or spotting may continue for several the aspiration weeks. – to check for molar pregnancy (send for histology, if • Normal menstruation should begin within 4–8 weeks. • Nausea, and sometimes vomiting, can last for up to 24 necessary). • In the absence of conception products, check for failure of the procedure, duplicate uterus, perforation or ectopic pregnancy. Routine laboratory examination of the hours. • Some cramps may occur over a few days. The patient should take analgesics (paracetamol). • The patient must know where to go if there is excessive products is not essential. bleeding, excessive pain, fever, fainting or other worrying Early complications and their management situations. An effective referral system must be in place. The management of early complications needs trained staff, The referral must be to a place that is accessible at all adequate equipment and a functional referral system. Staff times. must be trained to re-evacuate the uterus. A useful publication about complications after surgical abortion is available from the World Health Organization.12 • No douching and no tampons. • Sex: not until it is desired by the woman. No sexual intercourse until a few days after the main bleeding stops. • Stress the need to use contraception as soon as sexual Monitoring during the recovery period • Check vital signs on the treatment table. • No sedation or general anaesthesia: place the patient in a comfortable position in the recovery room. Observe for 30 minutes. activity is resumed. • Make a formal appointment for a follow-up visit five weeks later, or earlier if preferred. • The client should be given the opportunity to ask questions and seek any further support she may need. 12 World Health Organization (1994) Clinical Management of Abortion Complications: A Practical Guide, www.who.int/reproductive-health/publications/clinical_mngt_abortion_complications/text.pdf 12 Chapter 2 First trimester abortion Table 4: Early complications of surgically induced abortion (manual vacuum aspiration or dilatation and curettage) and their management Complication Signs Uterus is found empty • Minimal material, or none, collected Verify • No pregnancy? Test • Ectopic pregnancy? Use ultrasound if available • Possible recent complete spontaneous abortion • Possible duplicate uterus: rare Allergy to a drug • Hives (itchy skin eruption, • Check drug allergies swollen red bumps or patches), Treatment • If (intrauterine) pregnancy is confirmed, repeat aspiration • Ectopic pregnancy is a lifethreatening complication. Provide emergency local treatment, or refer • Administer diphenylhydramine 25–50mg IV • Severe reaction: 0.3cc rash • Occasionally: difficulty breathing epinephrine 1:1000 SC (can be repeated once, and then every 15–20 minutes) • Oxygen, start IV, protect airway Toxic reaction to lidocaine See Table 2 Incomplete evacuation • Tissue obtained does not Broken tip of plastic cannula (rare) • If there is any doubt this could correspond to the pregnancy be an indicator for using a duration. Signs can include curette. The procedure should be vaginal bleeding and abdominal performed smoothly, and only by pain trained staff • Cannula is broken • Repeat the procedure • Do not keep exploring the cavity. Use a fresh cannula to complete the procedure. The detached tip can either be aspirated or left (it will be expelled spontaneously) Perforation during hysterometry • The instrument penetrates (a procedure NOT recommended) beyond the expected size of the uterus • Usually resolves without any need for surgical intervention. Observe for 24 hours or refer. Give ergometrine 0.2mg (add one or maximum two doses if bleeding is still present) Suspected uterine or cervical perforation with incomplete evacuation • Perforation during manual vacuum aspiration is rare when using flexible cannulas. Suspect perforation if the cannula passes • Stop the procedure immediately and remove the cannula • Manage shock if necessary (see through the uterine cavity Table 7); do not administer without any resistance or goes methergine or oxytocin if there is in much further than expected suspected omentum or intestinal given the uterine size, if it is loop hernia difficult to withdraw the cannula, • Transfer the patient to an if omental fat or pieces of small obstetrics/gynaecology bowel are found in the aspirate, department at a hospital or if there are signs of shock 13 Chapter 2 First trimester abortion Table 4 continued: Early complications of surgically induced abortion (manual vacuum aspiration or dilatation and curettage) and their management Complication Signs Suspected uterine or cervical • The cannula has penetrated perforation after the evacuation beyond the expected size of the is complete uterus Verify • Verify if uterus has been Treatment • Begin IV fluids and antibiotics; emptied, using a curette very give ergometrine 0.2mg IM (plus gently one or maximum two doses if • The vacuum has decreased with bleeding continues), except if the cannula inside the uterine omentum or bowel hernia is cavity suspected • Sometimes: excessive bleeding, • Observe for 24 hours or refer • Check vital signs and abdominal atypical pain • Sometimes: fat, bowel or signs frequently during the first omentum observed (refer) two hours • If the condition worsens or bleeding continues under ergometrine or oxytocin, refer for surgery Abdominal pain • Severe uterine cramps/ contractions • Acute haematometra? See page 12 • Aspirate liquid and clotted blood promptly • Administer an oxytocic and start an antibiotic Haemorrhage • Excessive vaginal blood loss • Retained products of • Retention: empty the uterus conception? Cervical trauma? • Cervical trauma: five minutes of Very rare: endometrial angioma continuous compression. Suture (can necessitate hysterectomy) if bleeding does not stop, or refer Anaesthesia-related complications • See Table 2 • Competent staff must be • See Table 2 present; ensure narcotic reversal agents are always available Vasovagal reaction or syncope • Fainting, sweating, slow pulse, slow respiration, nausea, hypotension, lethargy • Check blood pressure, pulse, respiration • Stop the procedure • Maintain open airway • Turn patient to side (to prevent aspiration of vomitus or saliva) • Raise the patient’s legs • If the situation worsens: treat for shock – see Shock on page 21 Venous air embolism (very rare) • Anxiety, pallor, shortness of breath • Hypotension and hypoxemia are found in 10 per cent and 30 per cent of patients respectively, and chest pain in 23 per cent • In general, venous air embolism is transient and benign • Give oxygen and administer IV fluids (rapid flow) without delay 14 Chapter 2 First trimester abortion Table 5: Mode of action of drugs used for medical abortion, and their side-effects Drugs Action Side-effects Mifepristone • An anti-progestin that blocks the endometrial • Nausea, vomiting, diarrhoea, headache, dizziness, fatigue, progesterone receptors tachycardia • Stops the pregnancy growing, softens the cervix, increases the uterine contractility, causes bleeding • A prostaglandin that makes the uterus contract Misoprostol • Cramping (more pain than menstrual pain in 25% of patients), nausea, vomiting, diarrhoea, transient fever, dizziness, headache, chills, rashes Methotrexate • A folic acid antagonist that stops cellular division • Halts placental development Gemeprost • A prostaglandin that makes the uterus contract • Mild mouth sores, nausea, vomiting, gastro-intestinal disturbances, hot flushes, fever, chills • Nausea, vomiting, diarrhoea, transient fever, abdominal pain Table 6: Regimens for medical abortion and their effectiveness Regimens Effectiveness Use up to Mifepristone + misoprostol or >96% 9 weeks from last menstrual period Misoprostol alone >83% 12 weeks from last menstrual period Methotrexate + misoprostol >90% 9 weeks from last menstrual period mifepristone + gemeprost 15 Chapter 2 First trimester abortion • Porphyria. • Serious pelvic infection (signs: cervical motion tenderness, abnormal pelvic tenderness, adnexal mass, high fever, purulent cervical/vaginal discharge). Conditions erroneously cited as contraindications • Previous C-section(s), previous multiple birth(s), obesity, fibroids, uterine abnormalities. • Controversy remains as to whether asthma, heart disease, cardiovascular risk factors, renal and hepatic insufficiency, epilepsy are or are not contraindications. Referral to a specialist is recommended. • In breastfeeding women, although data are limited clinicians may advise women not to breastfeed (use pump, and discard breast milk) up to 72 hours after misoprostol or gemeprost administration. Counselling • Discuss the medical abortion methods available and the risks and benefits of each. Explain the side-effects (see Table 5). Explain sensibly the extremely (but not zero) small risk of major complications/death for all 16 Chapter 2 First trimester abortion options (there is a degree of risk involved in all medical interventions). The main complications – see Induced abortion: management of immediate, early and late complications on page 20 – are incomplete abortion, continuing pregnancy, haemorrhage, infection and adverse psychological sequelae (the latter in a very small number of women, influenced by pre-existing conditions). Bleeding and cramping indicate that the drugs are working. • Discuss the symptoms that warrant contacting the on-call provider, which include the following. – Heavy bleeding (give a criterion that is locally understood, such as soaking two or more big tampons or pads each hour for two consecutive hours). Explain that with drug-induced abortion, bleeding may be greater than during a heavy period, and can be accompanied by clots. Ensure a supply of sanitary towels for hygienic management of bleeding. In very few cases, bleeding will need to be stopped by a surgical procedure. Spotting may last up to 30 days. Some women may experience a heavy bleeding episode 3–5 weeks after the abortion. 17 Chapter 2 First trimester abortion – No bleeding at all within 24 hours: after misoprostol, and if an intrauterine pregnancy was not confirmed before treatment, ectopic pregnancy must be considered and managed appropriately. – Sustained fever (>38°C), or onset of fever in the days after misoprostol. – Foul-smelling vaginal discharge. described as cramping, is most intense during expulsion and lasts 2–4 hours, after which it usually subsides. • Bleeding starts in 50 per cent of users before taking misoprostol, but this drug is typically needed to complete the expulsion process. • An embryo is small and is usually not seen before 6–7 weeks from last menstrual period. – Severe, continuous or increasing abdominal pain. – “Feeling very sick” including weakness, nausea, vomiting or diarrhoea, more than 24 hours after taking Medical history, physical examination, laboratory, ultrasound See Pre-abortion visit on page 6. misoprostol. • Discuss the length of time involved for the abortion to be Regimens and follow-up complete and the need for several visits. • Mifepristone is not teratogenic, but foetal malformations have been reported after first trimester use of misoprostol (and of methotrexate). Women must be strongly advised and motivated to complete the abortion, medically or using aspiration (or dilatation and curettage), once the initial medications have been Disclaimer See Introduction on page 3. Some descriptions of medical abortion using mifepristone and misoprostol are partly based on a National Abortion Federation (NAF) protocol (March 2006) which reflects the US Food and Drug Administration (FDA)-approved labelling for mifepristone and which includes evidence-based alternatives to the administered. Inform the client that the follow-up visit FDA-approved regimen. NAF and FDA are not responsible to confirm complete abortion is essential. Make a formal for adverse clinical outcomes that might occur in the appointment for day 14 (earlier visits may be needed if course of delivery of abortion services. NAF standards anxiety or complications arise). and protocols can be found at www.prochoice.org/pubs_ • Vacuum aspiration must be available at any time for a patient experiencing a delay in the completion of the research/publications/downloads/professional_education/ cpgs_2007.pdf expulsion and who prefers aspiration rather than waiting for the medical abortion to be completed. • Discuss contraception (see Chapter 5), to be started as soon as possible after the abortion. The formal IPPF and World Health Organization recommended method • Mifepristone 200mg followed 36–48 hours later by 800µg appointment on day 14 should be used for checking that misoprostol (orally, sublingually, buccally or vaginally)14 at the procedure is complete, and discussing and providing once or in two doses of 400µg two hours apart,15 up to contraception. nine completed weeks after last menstrual period. • Provide additional explanations: – Oral administration means swallowing the tablet(s); in buccal administration the tablets should be retained between cheek and gum for 30 minutes before swallowing; sublingual administration means putting the tablets under the tongue until they disappear. – Vaginal misoprostol insertion can be done at home: the client must hand-wash before the insertion. Insert deeply, and lie still for 30 minutes. • Pain control: the patient should have oral pain medications and instructions for use. Pain is typically US Food and Drug Administration method • Day 1: Mifepristone 600mg (three 200mg tablets) taken as a single oral dose. • Day 2: Rh-negative clients will be administered Rh-immunoglobulin 50µg (the dose for pregnancies up to 12 weeks), no later than 48 hours after the abortion. • Day 3: Unless abortion has occurred and is confirmed by clinical examination (or ultrasonography), administer misoprostol 400µg (two 200µg tablets) as a single oral dose. 14 This regimen (with vaginal misoprostol) is recommended by the World Health Organization. The continuing pregnancy rate is around 1 per cent, and the success rate is more than 96 per cent. See Bibliography, page 32: World Health Organization, 2003. 15 The World Health Organization states that repeated doses of misoprostol increase the side-effects while increased effectiveness is not proven. See Bibliography, page 32: World Health Organization, 2006. 18 Chapter 2 First trimester abortion • Day 14: Clinically assess for completion of abortion (or Always ensure the availability of a back-up clinician to use ultrasonography or ß-hCG). Vacuum aspiration is assess possible complications. This is critical with medical recommended if a viable pregnancy is detected at this abortion as bleeding is less predictable, and heavy or time because the pregnancy may continue and there is a persistent bleeding may occur at home. For treatment, risk of foetal malformation. Increase of hCG can indicate vacuum aspiration, uterotonic agents, IV fluid administration an ongoing pregnancy. If hCG levels have declined by 50 and blood transfusion may be necessary, and can be per cent in 24 hours, the pregnancy has probably ended. provided in emergency only in primary health care clinics and Serum hCG should be below 1,000 IU/L two weeks after hospitals. mifepristone administration. Side-effects of the drugs Other commonly used evidence-based regimens See Table 5. Providers should be guided by accepted medical standards as well as by local regulations. Managing complications • Mifepristone 200mg followed 36–48 hours later by oral See Induced abortion: management of immediate, early and misoprostol 400µg, up to seven completed weeks after late complications on page 20. last menstrual period (it is less effective after seven It is essential to have staff trained in re-evacuation of weeks). After taking the prostaglandin, observe the the uterus, adequate equipment and a functioning referral woman for 4–6 hours. Inspect sanitary pads and bedpans system. to verify that abortion has taken place. Alternatively, misoprostol can be taken at home. • These regimens can be completed with an additional dose Abortion using misoprostol alone This regimen is less effective and has more side-effects than of misoprostol 800µg administered orally or vaginally in the combination regimens with mifepristone or methotrexate women with an incomplete abortion on day seven. This is pre-treatment, but where these drugs are not accessible, necessary in about 10 per cent of clients. Compared to medical abortion can be induced if misoprostol is the only oral misoprostol 400µg, using misoprostol 800µg vaginally drug available. Effectiveness is lower than for surgical has fewer gastrointestinal side-effects and increases the methods (84 per cent compared with 95 per cent). However, proportion of women with onset of bleeding and likely the safety level is much higher than resorting to unsafe, expulsion of pregnancy within four hours of misoprostol clandestine, illegal abortion. administration. Although misoprostol is formulated for oral use, it is more effective if given vaginally or sublingually. • Mifepristone 200mg, followed 36–48 hours later by Other regimens have been recommended: • Repeated doses of misoprostol 800µg, vaginally or sublingually (oral intake is less efficient), every three gemeprost 1mg vaginally is also used. Gemeprost is hours until abortion takes place, but with a maximum of quite expensive, must be kept frozen and induces more three doses. With three-hourly intervals the side-effects side-effects. • In China, five or six doses of 25mg mifepristone over are stronger than with 12-hourly intervals (see below). • Repeated doses of misoprostol 800µg vaginally every 12 three days, followed by a prostaglandin, is used up to hours until abortion takes place, but with a maximum of 49 days of gestation. three doses. Sublingual or oral administration at 12-hourly • Other variants have been tested. Sulprostone and 15-methyl PGF2α are no longer used. • Home administration of misoprostol has been found to be safe and effective and is highly acceptable to patients. If an Rh-negative client is going to take intervals is not sufficiently effective: 9 per cent of pregnancies continue if used up to nine weeks’ gestation. The failure rate is likely to be even higher if administered up to 12 weeks’ gestation. • With the two above regimens the complete abortion rate misoprostol at home, some protocols advise the is 84 per cent, continued pregnancy rate is around 5 per administration of Rh-immunoglobulin on day 1. In a cent, and the incomplete abortion (retained products) rate gestation of 6–12 weeks, administer 50µg IM; at or is approximately 11 per cent. beyond 13 weeks’ gestation, administer 300µg IM. 19 Chapter 2 First trimester abortion • Other protocols use misoprostol 800µg orally, vaginally or sublingually, which is repeated if abortion has not started by day 8, and again at day 11 if abortion has still not started. Follow-up is on day 21. • Days 5 to 7: If no bleeding has occurred, administer misoprostol 800µg orally, sublingually or vaginally. • Day 9: If no bleeding has occurred, administer a repeat dose of misoprostol 800µg. • Day 11: If no bleeding has occurred, administer a third If Rh-immunoglobulin is provided to Rh-negative women, dose of misoprostol 800µg. A maximum of three doses administer 50µg not later than 72 hours after the abortion. of misoprostol can be administered. If the client does This is not necessary before six weeks after last menstrual not abort after the third dose, a surgical procedure is period. recommended (preferably aspiration; or a dilatation and Foetal malformations have been reported after first curettage if aspiration is not available). trimester use of misoprostol. Therefore, women must be strongly advised to complete the abortion, either If Rh-immunoglobulin is routinely provided to Rh-negative medically or surgically, once the medication has been women, administer at the same time as the misoprostol, administered. or not later than 48 hours after the abortion. This is not necessary before six weeks after last menstrual period. Abortion using methotrexate + misoprostol available. The combination is more than 90 per cent effective Induced abortion: management of immediate, early and late complications for pregnancies up to nine weeks after last menstrual period. Staff must be trained and experienced, the equipment This regimen can be used where mifepristone is not Once methotrexate is administered, the abortion must be adequate and the referral system reliable. Staff must be able completed, because both drugs are teratogenic. Therefore, to (re-)evacuate a uterus, in cases of incomplete abortion women must be strongly advised to complete the or failure of medical abortion. Table 4 describes the early abortion, either medically or surgically, once the complications for surgical abortion and their management. medication has been administered. See also the World Health Organization publication on managing complications,16 especially the charts (which can Contraindications be printed and displayed on walls) on pages 9, 16, 34, 39 • Severe anaemia. and 46. Slightly modified versions can be found in Annex 2 • Known coagulopathy. on pages 35–39 of this publication. • Acute liver or renal disease. Complications which can occur after first trimester • Uncontrolled seizure disorder. abortion, whatever the technique, are considered next. They • Acute inflammatory bowel disease. are failed abortion, acute haematometra, shock, severe bleeding, infection and intra-abdominal injury. Administration • Day 1: Administer methotrexate 75mg IM or 50mg oral. Continuation of pregnancy (failed abortion) Failed As with the combined mifepristone + misoprostol regimen, abortion can occur after surgical and medical attempts; it give instructions about side-effects, possible requires a repeat aspiration (preferably) or dilatation and complications, follow-up and future contraception. After curettage. There seem to be scarce data, if any, about administering a prostaglandin (misoprostol, gemeprost or medical abortion used in cases of failed abortion. Any other), observe the woman for 4–6 hours. Inspect sanitary woman presenting with an incomplete abortion may also be pads and bedpans to verify that abortion has taken place. experiencing one or more life-threatening The following next steps can take place at the health complications: shock, severe vaginal bleeding, infection and centre or at home, depending on distances and client’s sepsis (see pages 21–24). preference. 16 World Health Organization (1994) Clinical Management of Abortion Complications: A Practical Guide, www.who.int/reproductive-health/publications/clinical_mngt_abortion_complications/text.pdf 20 Chapter 2 First trimester abortion Acute haematometra (sometimes called post-abortion syndrome) Initial treatment Acute haematometra can occur from a few hours to three protocols, but start initial treatment immediately. days after abortion. The uterus is tender and distended by • Make sure airway is open. blood, which causes rectal pressure. Cramping is present, • Check vital signs (pulse, blood pressure, breathing). together with vagal symptoms (tendency to faint, pallor, • Secure IV line. bradycardia, low blood pressure, low respiration, sweating). • Keep the patient warm. There is minimal or no vaginal bleeding. The treatment • Turn body and head to the side (if the woman vomits, she consists of prompt aspiration of both liquid and clotted blood, leading to rapid resolution. An oxytocic (misoprostol, Refer, if necessary, according to local capacities and is less likely to aspirate). • Raise legs (or the foot of the bed). However, if this causes oxytocin or ergometrin) is administered after the repeat difficulty in breathing, there may be pulmonary oedema evacuation. Antibiotherapy is added. or heart failure. In this case, lower the legs and raise the head to relieve fluid pressure on the lungs. • Give IV Ringer’s lactate or isotonic solution 1L for 15–20 Shock Signs minutes (16–18 gauge needle). It may take 1–3L to Shock results from blood loss and/or sepsis, pain being an stabilize a patient in shock. Do not give fluids by aggravating factor. Oxygen supply to tissues is interrupted. mouth. It is a highly unstable condition with a high risk of mortality. Possible signs are fast (>110/minute) and weak pulse; low blood pressure; pallor of the skin around the mouth or on the palms; pale conjunctiva; rapid respiration (>30/minute); anxiety; confusion; dizziness; loss of consciousness. Treat immediately, and start IV perfusion at once. Treat the shock first; then treat the cause. • If available, give oxygen 6–8L/minute (mask or nasal cannula). • Remove any visible products of conception in the cervical os. • If haemoglobin is <5g/dL or haematocrit <15%, a blood transfusion is necessary. • Strictly monitor the amounts of fluids/blood given (use a chart). Table 7: Signs of early and late shock Signs of early shock (can usually be treated at the primary health care level) Signs of late shock (must usually be treated at referral level) Pulse >110/minute Fast and weak Blood pressure Systolic <90mmHg Very low Pallor Inner eyelid, palms, around the mouth Very pale Breathing >30/minute Very fast and shallow Awareness Awake, anxious Confusion or unconsciousness Lungs Clear Dense Haemoglobin ≥8g/dL <8g/dL Haematocrit ≥26% <26% Urine output ≥30mL/h <30mL/h Skin Pale Cold, clammy, sweating 21 Chapter 2 First trimester abortion • Monitor urine output. If urine is very dark, if the output is Severe genital bleeding decreased or absent, refer. Shock, blood volume Signs depression (for example due to haemorrhage or severe • Moderate to light vaginal bleeding is characterized by diarrhoea), sepsis, and ureterine damage can cause clean pad not soaked after five minutes, fresh blood oliguria or anuria. Rapid correction of the circulating mixed with mucus, no clots. volume is necessary, as well as the elimination of the underlying cause. Infuse quickly with fluids: 50–200mL of normal saline or lactated Ringer solution over a 10-minute period. • If there is infection (fever, chills, pus) give broad spectrum • Severe bleeding may be caused by trauma (to the vagina, cervix, uterus), retained products of conception, fibroids or atony. • Signs: heavy, bright red blood with or without clots; blood-soaked pads, towels or clothing; pallor (inner antibiotics, IV preferably, or IM. No medications by eyelids, palms, around the mouth); dizziness, syncope, mouth. hypotension. • Laboratory work is helpful but must not cause any delay in treatment. Request haemoglobin, haematocrit, blood • There is a risk of shock if bleeding continues: treat shock, if it develops. group and rhesus pre-transfusion (type and cross-match), platelet count and, if available, blood electrolytes, pH, Initial treatment for severe genital bleeding urea and/or creatinine. • Make sure airway is open. • Check vital signs (pulse, blood pressure, breathing). Signs of stabilization • Secure IV line. • Increasing blood pressure; systolic blood pressure • Keep the patient warm. ≥100mmHg. • Heart rate <90/minute. • Raise the patient’s legs (or the foot of the bed). • Control bleeding, if possible and as appropriate by use of • Conscious, reduced confusion/anxiety. oxytocics, tamponing, uterine massage, emptying the • Skin colour improves. uterus surgically (preferably using aspiration), suturing or • Respiration rate decreases or is <30/minute. bimanual internal/external compression. • Urine output increases and is >100mL/4h. • If available, give oxygen 6–8L/minute (mask or nasal cannula). Continuing treatment for shock • During the following steps prepare concomitantly for referral; if the situation worsens, refer without delay. • If patient is not stabilizing after 20–30 minutes: – continue monitoring, oxygen and IV fluids – reassess the need for antibiotics – promptly begin the treatment of underlying cause(s) of shock • If patient is not stabilized after two hours, refer immediately. • If patient is stabilizing: – gradually shut off oxygen. If this causes worsening of some or all the signs in Table 7, turn oxygen back to 6–8L/minute – decrease IV fluid administration to 1L/6–8h • Give IV Ringer’s lactate or isotonic solution 1L for 15–20 minutes (16–18 gauge needle). It may take 1–3L to stabilize a patient who has lost a lot of blood. Do not give fluids by mouth. • If haemoglobin is <5g/dL or haematocrit <15%, a blood transfusion is necessary. • Strictly monitor the amounts of fluids/blood given (use a chart). • Monitor the urine output for decrease or absence. A darker colour indicates a reduced output. An increase is a good sign. • Give IV or IM analgesia for pain. • If there is infection (fever, chills, pus) give broad spectrum antibiotics, IV preferably, or IM. No medications by mouth. – continue antibiotics if they have been started • If needed, give tetanus toxoid and tetanus antitoxin. – treat the underlying cause(s) of shock • Laboratory work is helpful but must not cause any delay in treatment. Request haemoglobin, haematocrit, blood group and rhesus pre-transfusion (type and cross-match), 22 Chapter 2 First trimester abortion platelet count and, if available, blood electrolytes, pH, • Abdominal/pelvic pain, distended abdomen, rebound urea and/or creatinine. A drop in haemoglobin and tenderness and abnormal tenderness on bimanual pelvic haematocrit can lag 6–8 hours behind the actual blood examination. loss (time required for equilibrium). • Sub-involution of the uterus. • Uterine and cervical motion tenderness. Signs of stabilization • Increasing blood pressure; systolic blood pressure ≥100mmHg. • Heart rate <90/minute. • Skin colour improves. • An adnexal mass may be present (this could be an abscess). • Shoulder pain can be a sign of ectopic pregnancy (this is due to irritation of the superior part of the peritoneum) or of intra-abdominal injury. • Urine output increases and exceeds 100mL/4h. • Prolonged vaginal bleeding (check for clots or signs of Continuing treatment for severe vaginal bleeding • Laboratory tests: raised white blood cell count. anaemia) or spotting. • Continue monitoring, oxygen and IV fluids as long as patient is unstable. • If patient is stabilizing: – gradually shut off oxygen. If this causes worsening (some or all signs in Table 7), turn oxygen back to 6–8L/minute. – decrease IV fluid administration to 1L/6–8h. Continue the blood transfusion as programmed and started – reassess/continue antibiotics, pain control, tetanus Infection: assessment of the situation Determine whether there is high or low risk of the patient developing septic shock (see Table 7). • Low risk of developing septic shock: mild/moderate fever (<38.5°C and >36.5°C), stable vital signs (pulse, blood pressure, breathing), no evidence of intra-abdominal injury. • High risk of developing septic shock: temperature preventive measures if they have been started or need ≥38.5°C or ≤36.5°C, OR second trimester pregnancy OR to be started. evidence of intra-abdominal injury (distended abdomen, decreased bowel sounds, rigid abdomen, rebound Infection and sepsis tenderness, nausea, vomiting) OR any evidence of shock This can be related or unrelated to retained products (low blood pressure, anxiety, confusion, unconsciousness, of conception. Infection may be limited to the cervix or pallor, rapid breathing, weak pulse). uterus, or there may be generalized sepsis. Immediate treatment is required in any case. Monitor carefully for Initial treatment for sepsis signs of septic shock. Give broad spectrum antibiotics • Make sure airway is open. immediately. Take blood for culture. Any woman • Monitor vital signs (pulse, blood pressure, breathing). presenting with an infection after abortion may also be • Give fluids: IV Ringer’s lactate or isotonic solution 1L for experiencing one or more life-threatening complications: 15–20 minutes (use a 16–18 gauge needle). It may take shock, severe vaginal bleeding or septicaemia. If abortion is 1–3L to stabilize a patient in shock. Do not give fluids performed properly under asepsis, infections are rare, but some, such as septicaemia, can be very dangerous and can be fatal. by mouth. • Strictly monitor the amounts of fluids/blood given (use a chart). • If the patient is at high risk of shock, begin IV Signs and symptoms antibiotics immediately and treat for shock. Use • Perform a general physical examination. broad spectrum antibiotics, effective against Gram • Chills, high fever, sweats, influenza-like symptoms (can negative and positive, anaerobic organisms and be absent, especially in some very dangerous clostridium infections). • Mildly low blood pressure. • Foul-smelling or muco-purulent vaginal discharge. Chlamydia. • According to the patient’s vaccination status, give IM tetanus toxoid and/or tetanus antitoxin. • Give IV or IM analgesics. 23 Chapter 2 First trimester abortion • Oxygen is not necessary if the patient is stable and the Intra-abdominal injury risk of shock is low. If the patient becomes unstable, and Perforation during hysterometry (a procedure NOT if it is available, give oxygen 6–8L/minute (mask or nasal recommended) and suspected uterine or cervical perforation cannula). with incomplete or complete evacuation are considered • Laboratory work is helpful but must not cause any delay in treatment. If the patient has lost a lot of blood, assess earlier (see Table 4). Perforation of and damage to surrounding organs is haemoglobin, haematocrit, blood group and rhesus possible, and carries the risk of infection and sepsis. pre-transfusion (type and cross-match), complete blood Differential diagnosis: ruptured ectopic pregnancy, ruptured count to assess anaemia and infection and the possibility abscess, ruptured ovarian cyst, acute appendicitis. of disseminated vascular coagulation, and platelet count Symptoms that may be present include abdominal (if there is disseminated vascular coagulation, the platelet pain, cramping; tense, hard, distended abdomen, rebound count will be low). If available, ask for blood electrolytes, tenderness; decreased bowel sounds; nausea, vomiting; pH, urea and/or creatinine. shoulder pain; fever; shock; sepsis. • Monitor urine output for decrease or absence. A darker colour indicates a reduced output. An increase is a good Initial treatment for intra-abdominal injury sign. • Check vital signs (pulse, blood pressure, breathing). • If possible take a flat-plate abdominal X-ray to check for • Check haemoglobin or haematocrit. air and fluid levels in the bowels, and an upright abdominal one to check for air under the diaphragm. This If there are signs of shock (see page 21 and Table 7): signals uterine or bowel perforation. • Raise the patient’s legs. • Treat the underlying cause of infection: re-evacuate the uterus. • Check for signs of gas gangrene, tetanus, intra-abdominal injuries, peritonitis and pelvic abscesses. • Remove intrauterine device if present. • Make sure airway is open. • Do not give anything by mouth. • If available start oxygen 6–8L/minute. • Give fluids: IV Ringer’s lactate or isotonic solution 1L for 15–20 minutes (use a 16–18 gauge needle). It may take 1–3L to stabilize a patient who has lost a lot of blood or Signs of stabilization • Increasing blood pressure; systolic blood pressure ≥100mmHg. • Heart rate <90/minute. is in shock. • If haemoglobin is <5g/dL or haematocrit <15%, a blood transfusion is necessary. • Immediately begin broad spectrum antibiotics IM • Skin colour improves. or, preferably, IV. Use antibiotics effective against • Urine output increases and exceeds 100mL/4h. Gram negative and positive, anaerobic organisms and Chlamydia. Continuing treatment for sepsis • If necessary, give tetanus toxoid and tetanus antitoxin. • Continue monitoring vital signs, urine output, fluids/blood • Give analgesics. volume administration. • If oxygen has been given, gradually shut it off. If this causes deterioration, turn oxygen back to 6–8L/minute. • If IV fluids were started to administer antibiotics, continue with the IV treatment. • Once the fluid volume has been corrected, decrease IV fluid administration to 1L/6–8h. • If haemoglobin is <5g/dL or if haematocrit is <15%, a blood transfusion is necessary. • Laboratory work is helpful but must not cause any delay in treatment. Assess haemoglobin, haematocrit, blood group and rhesus pre-transfusion (type and cross-match), complete blood count to assess anaemia and infection and the possibility of disseminated vascular coagulation, and platelet count (if there is disseminated vascular coagulation, the platelet count will be low). If available, ask for blood electrolytes, pH, urea and/or creatinine. • Monitor urine output for decrease or absence. A darker colour indicates a reduced output. An increase is a good sign. 24 Chapter 7 Equipment, instruments, supplies, drugs and medications • If possible take a flat-plate abdominal X-ray to check for gas in the peritoneal cavity, and an upright (or, if impossible, a lateral) abdominal one (the presence of gas is a sign of uterine or bowel perforation). • If necessary, remove the retained products of conception, assessing the complete evacuation of the uterus under direct visual control (laparoscopy, mini-laparotomy or ultrasound if available) and assessing damage to the pelvic organs. Repair the vessels, bowel and other abdominal organs surgically. If laparotomy or laparoscopy cannot be performed, stabilize and refer the patient. After surgery, give oxytocics and observe the vital signs every 15 minutes for two hours; then give ergometrine 0.2–0.5mg IM and observe overnight. If the patient worsens, refer. Signs of stabilization and improvement • Increasing blood pressure; systolic blood pressure ≥100mmHg. • Heart rate <90/minute. • Skin colour improves. • Urine output increases and exceeds 100mL/4h. Continuing treatment of intra-abdominal injury • Continue to monitor vital signs, urine output and fluids. • For surgical repair, refer. 31 Chapter 7 Equipment, instruments, supplies, drugs and medications Equipment, instruments, supplies, drugs and medications Running water, clean toilet facilities, adequate infection prevention techniques and sensible disposal of conception materials (according to local guidelines and clients’ desires) are essential. Infection prevention The following are required: • sterile gloves (small, medium, large) • detergent • soap • chlorine or glutaraldehyde • large containers for the above • high level disinfection or sterilization agent • water-based antiseptic solution for cleaning vulva and vagina • small container for antiseptic solution • cotton swabs or gauze sponges Aspiration using manual vacuum aspiration syringe or electric vacuum pump The following are required: • syringes (5, 10, 20mL) • needles: – 22 gauge spinal for cervical block – 21 gauge for drug administration • speculum • tenaculum • sponge (ring) forceps • dilators (Hegar: sizes 4–14mm) • vacuum aspirator (manual vacuum aspiration syringe or electric pump + tube) • flexible cannulas (sizes 6–12 or 14) plus adaptors, if needed • silicone for lubricating syringes, if needed • medications: – analgesics (for example acetaminophen, ibuprofen, pethidine) 31 Chapter 7 Equipment, instruments, supplies, drugs and medications – lidocaine or similar: 0.5, 1 or 2 per cent without epinephrine – oxytocin 10 International Units – ergometrine 0.2mg • strainer (or gauze) • clear glass dish for inspecting products of conception • all contraceptives (including emergency contraception) used locally Dilatation and curettage The following are required: • sterile gloves (small, medium, large) • infection prevention: see left • speculums of various sizes (Collin is preferred rather than Sims, Cusco, Graves or valve(s)) • sponge (ring) holding forceps • tenaculum forceps • volsellum • set of Hegar dilators • set of three curettes of different diameters • gauze, compresses • antibiotics Medical (drug-induced) abortion The following are required: • mifepristone or methotrexate and misoprostol, or misoprostol alone • antibiotics: metronidazole, doxycycline • analgesics: paracetamol (= acetaminophen), ibuprofen, codeine • uterotonics: injectable ergometrine; injectable oxytocin • iron tablets 31 Chapter 7 Equipment, instruments, supplies, drugs and medications Emergency room drugs, supplies and posters The following are required: • sphygmomanometer, stethoscope, thermometer, torch • gloves, syringes, needles • IV infusion set, IV fluids (sodium lactate, glucose, saline) • emergency bag with resuscitation equipment and oxygen • vaginal speculums • spatulae for vaginal/cervical mucus/pus • refrigerator • autoclave • antibiotics, analgesics, diazepam, epinephrine (adrenaline) 1:1,000 1mg/mL • emergency protocols poster to display on the wall (so all staff know what to do) 31 Annex 2 Clinical management of abortion complications Pre-abortion ultrasound and laboratory testing Ultrasound This is not needed routinely. Use according to local protocols. Ultrasound should not be a prerequisite for abortion. Ultrasound can be useful (but is not 100 per cent sensitive or specific) to confirm pregnancy duration, detect an ectopic pregnancy, or show a molar pregnancy (‘snow storm’ appearance). If ultrasound is indicated (not routinely), it is better to use a vaginal probe than an abdominal one. Look for the gestational sac, the yolk sac, the embryonic pole and the presence of cardiac activity. If an embryonic pole is visible, use its measurement to estimate the gestation duration as it is more accurate than the measurement of the gestational sac. The absence of an intrauterine sac could indicate early intrauterine pregnancy, ectopic pregnancy or an abnormal intrauterine pregnancy. With no intrauterine sac seen (using a vaginal probe) and a serum ß-hCG >2,000mIU/mL, an ectopic pregnancy must be considered. The same applies if ß-hCG is >3,600 and an abdominal probe is used. In such cases further evaluation and/or treatment is warranted. Laboratory testing Laboratory testing should not be a prerequisite for abortion. There are no essential tests. • A pregnancy test is not required routinely; only if the pregnancy is uncertain. • Haemoglobin/haematocrit if anaemia is suspected. • ABO-Rh where available is useful if transfusion can be accessed. Certainly needed if Rh-immunoglobulin is available and provided (this is best practice) to Rh-negative women (within 48–72 hours of abortion; unnecessary before six weeks’ gestation). • HIV test, other tests for sexually transmitted infections or tests related to specific individual health problems can be proposed or may be necessary. • Cervical cultures should be performed according to local protocols, or if signs of vaginal/cervical infection are present. • Screening for cervical cancer can be done if facilities exist. 35 Annex 2 Clinical management of abortion complications Annex 2 Clinical management of abortion complications Chart 1: Initial assessment Presentation Initial step If there are signs of shock After an abortion, or in a woman of reproductive age possibly having been pregnant, in presence of: • excessive vaginal bleeding • cramping or lower abdominal pain • fever • signs of shock Assess for shock • Rapid, weak pulse • Low blood pressure • Pale and sweaty • Rapid breathing • Anxious, confused or unconscious Immediate action is required (see page 21 and Table 7) Complete clinical assessment Review history: Length of amenorrhoea/last menstrual period, duration and amount of bleeding, duration and severity of cramping, abdominal pain, shoulder pain, drug allergies Physical examination: Vital signs, heart, lungs, abdomen, extremities Indication of systemic problem (shock, sepsis etc) Pelvic examination: Uterine size, stage of abortion, uterus position Other: Remove any visible products of conception from the cervical os Determine rhesus status if possible Shock Early • Pulse >110/minute • BP <90mmHg systolic • Pale and sweaty skin • Breathing >30/minute • Awake • Anxious • Lungs clear • Haematocrit ≥26% • Urine output ≥30mL/h See Chart 2 Late • Weak pulse, very rapid • BP very low • Pale and cold skin • Breathing rapid • Unconscious • Confused • Pulmonary oedema • Haematocrit <26% • Urine output <30mL/h Intra-abdominal injury • Abdominal pain, cramping • Distended abdomen • Decreased bowel sounds • Tense, hard abdomen, rebound tenderness • Nausea, vomiting • Shoulder pain • Fever See Chart 4 Infection and sepsis • Chills, fever, sweats • Foul-smelling vaginal discharge • History of interference with the pregnancy • Abdominal pain • Intrauterine device in place? • Prolonged bleeding • Influenza-like symptoms See Chart 5 Severe vaginal bleeding • Heavy, bright red vaginal bleeding with or without clots, blood soaked pads, towels, clothing • Pallor See Chart 3 35 Annex 2 Clinical management of abortion complications Chart 2: Shock Initial treatment Shock Early • Pulse >110/minute • BP <90mmHg systolic • Pale and sweaty skin • Breathing >30/minute • Awake • Anxious • Lungs clear • Haematocrit ≥26% • Urine output ≥30mL/h Late • Weak pulse, very rapid • BP very low • Pale and cold skin • Breathing rapid • Unconscious • Confused • Pulmonary oedema • Haematocrit <26% • Urine output <30mL/h • Make sure airway is open • Check vital signs (pulse, blood pressure, breathing) • Secure IV line: Ringer’s lactate or isotonic solution 1L for 15–20 minutes (16–18 gauge needle). It may take 1–3L to stabilize a patient in shock • Turn body and head to the side, raise legs (however, if this causes difficulty in breathing, lower legs and raise head) • No fluids by mouth • Give oxygen 6–8L/minute (if available) • Remove any visible products of conception from the cervical os • Blood transfusion: if haemoglobin <5g/dL or haematocrit <15% • Monitor amount of fluids/blood given – use a chart • Monitor urine output – colour and quantity • IV antibiotics – in case of infection • No medications by mouth • Laboratory work is helpful but must not cause any delay in treatment. Request haemoglobin, haematocrit, blood group and rhesus pre-transfusion (type and cross-match), platelet count and, if available, blood electrolytes, pH, urea and/or creatinine. Assess response to fluids after 20–30 minutes Signs of stabilization • Increasing systolic BP, ≥100mmHg • Heart rate <90/minute • Conscious, reduced confusion/anxiety • Skin colour improves • Respiration rate ≤30/minute • Urine output >100mL/4h If stable If not stable • Gradually shut off oxygen. If this causes worsening, turn oxygen back on 6–8L/minute • Clinical assessment • Uterine evacuation • Continue monitoring oxygen and IV fluids • Reassess the need for antibiotics • Treat underlying cause(s) of shock If stable Assess after two hours • Adjust IV and oxygen • Complete clinical assessment • Continue treating underlying cause(s) of shock • Uterine evacuation Signs of stabilization • Increasing systolic BP, ≥100mmHg • Heart rate <90/minute • Conscious, reduced confusion/anxiety • Skin colour improves • Respiration rate ≤30/minute • Urine output >100mL/4h If not stable Refer to secondary or tertiary hospital Ref: WHO/FHE/MSM/94.1 35 Chart 3: Severe vaginal bleeding Presentation Initial treatment • Heavy, bright red blood from vagina, with or without clots • Blood soaked pads, towels or clothing • Pallor • Dizziness • Syncope • Hypotension • Make sure airway is open • Check vital signs (pulse, blood pressure, breathing) • Secure IV line • Keep the patient warm • Raise the patient's legs • Control bleeding (if possible by use of oxytocics, tamponing, uterine massage, emptying the uterus by aspiration, suturing or bimanual internal/external compression) • Oxygen 6-8Uminute (if available) • IV Ringer's lactate or isotonic solution 1 L for 15-20 minutes (16-18 gauge needle). It may take 1-3L to stabilize a patient who has lost a lot of blood • Do not give fluids by mouth • Blood transfusion if haemoglobin <5g/dolr haematocrit <15% • Monitor amount of fluids/blood given -use a chart • Monitor urine output: dark colour indicates reduced output. Increase is a good sign • If infection is present,give antibiotics IV or IM • No medications by mouth • If needed, give tetanus toxoid and tetanus antitoxin • Laboratory work is helpful but must not cause any delay in treatment. Request haemoglobin,haematocrit, blood group and rhesus pre-transfusion (type and cross-match), platelet count and, if available, blood electrolytes, pH, urea and/or creatinine. A drop in haemoglobin and haematocrit can lag 6-8 hours behind the actual blood loss. Signs of stabilization • • • • BP, systolic ;o-1OOmmHg Heart rate <90/minute Skin colour improves Urine output >1OOmU4h Suspicion of intraabdominal injury • Rigid abdomen, acute abdominal pain • Immediate assessment is required • Emergency laparotomy may be indicated See Chart 4 Visible cervical or vaginal laceration Incomplete abortion • Cervix open • Uterine size is smaller or= dates of la st menstrual period -+ • Give IV or IM analgesics for pain • Repair laceration • Continue monitoring oxygen, IV fluids • Determine uterine size at presentation If no IV facilities: • • • • Pain control Uterine evacuation Uterine massage Prepare for referral Evidence of uterine perforation ---+- • Instrument extends beyond uterus • Fat or bowel in specimen • Management depends on whether or not evacuation is complete. If not, evacuate • Continue IV fluids Evacuate uterus <;14 weeks >1 4 weeks Manual vacuum aspiration or dilatation and curettage Misoprostol or dilatation and curettage Ref:WH0/FHE/MSM/94.1 Chart 4: Intra-abdominal injury Suspected or confirmed uterine or cervical perforation during electric vacuum aspiration/manual vacuum aspiration/dilatation and curettage, or hysterometry (a procedure NOT recommended) Suspected or confirmed abdominal injury detected post-abortion Signs of shock Early • Pulse >110/minute • BP <90mmHg systolic • Pale and sweaty skin • Breathing >30/minute • Awake • Anxious • Lungs clear • Haematocrit ≥26% • Urine output ≥30mL/h See Chart 2 Late • Weak pulse, very rapid • BP very low • Pale and cold skin • Breathing rapid • Unconscious • Confused • Pulmonary oedema • Haematocrit <26% • Urine output <30mL/h Management of shock NO YES YES See Chart 2 NO Is uterus empty? Verify by gently using a curette YES • Observe for 24 hours • Ergometrine 0.2mg IM Transfer to tertiary health care/ hospital preferably to obstetrics and gynaecology unit NO • • • • Haemorrhage Fever Severe pain Signs of shock • IV Ringer’s lactate or isotonic solution 1L for 15–20 minutes (16–18 gauge needle) • Antibiotics IV/IM YES NO Client can be discharged Chart 5: Infection and sepsis Presentation Initial assessment of risk for septic shock • • • • • • • • • • • • • • • Chills, high fever,sweats,influenza-like symptoms Mildly low blood pressure Foul-smelling or muco-purulent vaginal discharge Abdominal/pelvic pain, distended abdomen Rebound tenderness Sub-involution of the uterus Uterine and cervical motion tenderness Shoulder pain Prolonged vaginal bleeding Length of gestation Check vital signs Check for signs of pelvic infection Foreign materials in vagina Pus in cervix or vagina Evidence of local pelvic infection - adnexal tenderness - uterine tenderness - cervical motion tenderness - lower abdominal tenderness - foul odour to any blood or secretions,urine,faeces I Low risk of septic shock High risk of septic shock • Mild/moderate fever <38.5°C and >36.5°C • Vital signs stable • No evidence of intra-abdominal injury • Fever >38.5°C or <36.5°C • Evidence of intra-abdominal injury (distended abdomen, rebound tenderness) • Nausea and vomiting • Low blood pressure • Anxiety, confusion, pallor, rapid breathing,weak pulse • Unconscious Initial treatment Initial treatment • Make sure airway is open • Monitor vital signs (pulse,blood pressure,breathing) • IV fluids: Ringer's lactate or isotonic solution 1 L for 15-20 minutes • Do not give fluids by mouth • Antibiotics (IV preferred) • Tetanus toxoid and tetanus antitoxin • Analgesics IM • Make sure airway is open • Check vital signs (pulse,blood pressure,breathing) • Secure IV line: Ringer's lactate or isotonic solution 1L for 15-20 minutes (16-18 gauge needle). It may take 1-3L to stabilize a patient in shock • Turn body and head to the side,raise legs (however,if this causes difficulty in breathing, lower legs and raise head) • No fluids by mouth • Give oxygen 6-8Uminute (if available) • Remove any visible products of conception from the cervical os • Blood transfusion: if haemoglobin <5g/dL or haematocrit <15% • Monitor amount of fluids/blood given -use a chart • Monitor urine output- colour and quantity • IV antibiotics- in case of infection • No medications by mouth • Abdominal X-ray- to detect uterine or bowel perforation • Laboratory work is helpful but must not cause any delay in treatment. If the patient has lost a lot of blood, assess haemoglobin, haematocrit, blood group and rhesus pre-transfusion (type and cross-match), complete blood count to assess anaemia and infection and the possibility of disseminated vascular coagulation,and platelet count (if there is disseminated vascular coagulation,the platelet count will be low). If available,ask for blood electrolytes, pH,urea and/or creatinine I J If patient is stable • Continue antibiotics and IV • Uterine evacuation • Observe for 48 hour s If signs of disseminated vascular coagulation are present • Blood does not clot • Bleeding from veni-puncture sites etc • Uterine evacuation • Blood transfusion J J J Signs of gas gangrene or tetanus Signs of intra-abdominal injury If signs of shock develop • Gas gangrene: X-ray shows gas in pelvis • Tetanus: painful muscle contractions, generalized spasms,convulsions • Refer to tertiary care centre after initial stabilizing efforts + • X-ray shows air in the abdomen,abdomen rigid, rebound tenderness • Dropping blood pressure • Fast,weak pulse • Continue oxygen, antibiotics and IV fluids • Emergency Iaparotomy, or refer immediately to tertiary care centre • Rapid breathing • Pallor Immediate attention is required • Refer to tertiary care antibiotics and sedation if See Chart 4 CHILDBIRTH / OBSTETRICAL EMERGENCIES ABNORMAL BIRTH EMERGENCIES UNIVERSAL PATIENT CARE PROTOCOL B EMT – B B I P M EMT – I EMT – P MED CONTROL I P M CORD AROUND NECK PROLAPSED CORD BREECH BIRTH SHOULDER DYSTOCIA Loosen cord or clamp and cut if too tight Transport mother with hips elevated and knees to chest Transport unless delivery is imminent Transport mother with hips elevated and knees to chest Continue Delivery Insert fingers to relieve pressure on cord Do not encourage mother to push Insert fingers to relieve pressure on cord Support but do not pull presenting parts Place pressure on symphisis pubis If delivery is in process and the head is caught inside vagina, create air passage by supporting body of infant and placing 2 fingers along sides of nose, and push away from face to facilitate an airway passage If unable to deliver, transport mother with hips elevated and knees to chest CONTACT MEDICAL CONTROL TRANSPORT CHILDBIRTH / OBSTETRICAL EMERGENCIES ABNORMAL BIRTH EMERGENCIES CONTACT MEDICAL CONTROL IMMEDIATEL WHEN ANY ABNORMAL BIRTH PRESENTATION IS DISCOVERED HISTORY • • • • • • Past medical history Hypertension meds Prenatal care Prior pregnancies / births Gravida / Para Ultrasound findings in prenatal care SIGNS AND SYMPTOMS • • • • • Frank Breech (buttocks presents first) Footling Breech (one foot or both feet presenting) Transverse Lie (fetus is on his/her side with possible arm or leg presenting) Face First Presentation Prolapsed Cord (umbilical cord presents first) DIFFERENTIAL DIAGNOSIS • • Miscarriage Stillbirth KEY POINTS General Information • DO NOT pull on any presenting body parts. • These patients will most likely require a c-section, so immediate transport is needed. • Prolonged, non-progressive labor distresses the fetus and mother. Be sure to reassess mother’s vital signs continuously. Cord Around Baby's Neck • As baby's head passes out of the vaginal opening, feel for the cord. Initially try to slip cord over baby’s head; if too tight, clamp cord in two places and cut between the clamps. Breech Delivery • Footling Breech (one or both feet delivered first) • Frank Breech (buttocks first presentation) • When the feet or buttocks first become visible, there is normally time to transport patient to nearest facility. • If upper thighs or the buttock have come out of the vagina, delivery is imminent. • If the child's body has delivered and the head appears caught in the vagina, the EMT must support the child's body and insert two fingers into the vagina along the child's neck until the chin is located. At this point, the two fingers should be placed between the chin and the vaginal canal and then advanced past the mouth and nose. • After achieving this position a passage for air must be created by pushing the vaginal canal away from the child's face. This air passage must be maintained until the child is completely delivered. Prolapsed Cord • When the umbilical cord passes through the vagina and is exposed, the EMT should check cord for a pulse. • The patient should be transported with hips elevated or in the knee chest position and a moist dressing placed around the cord. • If umbilical cord is seen or felt in the vagina, insert two fingers to elevate presenting part away from cord, distribute pressure evenly when the occiput presents. • DO NOT attempt to push the cord back. High flow oxygen and transport IMMEDIATELY. Shoulder Dystocia • Following delivery of the head, the shoulder(s) become “stuck” behind the symphysis pubis or sacrum of the mother. • Occurs in approximately 1% of births. Excessive Bleeding Pre-Delivery • If bleeding is excessive during this time and delivery is imminent, in addition to normal delivery procedures, the EMT should use the Hypovolemic Shock Protocol. • If delivery is not imminent, patient should be transported on her left side and Shock Protocol followed. Excessive Bleeding Post-Delivery • If bleeding appears to be excessive, start IV of saline. • If placenta has been delivered, massage uterus and put baby to mother's breast. • Follow Hypovolemic Shock Protocol. CHILDBIRTH / OBSTETRICAL EMERGENCIES OBSTETRICAL EMERGENCIES B EMT – B B I P M EMT – I EMT – P MED CONTROL I P M UNIVERSAL PATIENT CARE PROTOCOL MONITOR/IV PROTOCOL Vaginal Bleeding / Abdominal Pain? No Yes Hypertension? Known Pregnancy / Missed Period? Yes No Yes Mild Pre-eclampsia – (BP >140/90, Peripheral Edema) 1st Trimester – Miscarriage, Ectopic Pregnancy Severe Pre-eclampsia – (BP >140/90, Edema, Headache, Visual Disturbances) Eclampsia – Seizures – other signs absent No 2nd & 3rd Trimester – Placeta Previa Abruptio Placenta Yes Magnesium sulfate 1.0 to 4.0 grams slow IV push over 2-3 minutes Versed 5 mg IV/IM/Nasal Call Medical Control for Valium Order Rapid Transport NORMAL SALINE IV, 500 cc BOLUS Pad bleeding, save and bring with patient Childbirth Imminent Delivery Protocol Rapid Transport CONTACT MEDICAL CONTROL No See Abdominal Pain Protocol Transport CHILDBIRTH / OBSTETRICAL EMERGENCIES OBSTETRICAL EMERGENCIES SIGNS AND SYMPTOMS DIFFERENTIAL DIAGNOSIS HISTORY • • • • • Past medical history Hypertension meds Prenatal care Prior pregnancies / births Gravida / Para • • • • • • • Vaginal bleeding Abdominal pain Seizures Hypertension Severe headache Visual changes Edema of hands and face KEY POINTS • • • • Pre-eclampsia / Eclampsia Placenta previa Placenta abruptio Spontaneous abortion General Information • Exam: Mental Status, Abdomen, Heart, Lungs, Neuro. • May place patient in a left lateral position to minimize risk of supine hypotensive syndrome if in late 2nd or 3rd trimester. • Ask patient to quantify bleeding - number of pads used per hour. • Any pregnant patient involved in a MVC should be seen immediately by a physician for evaluation and fetal monitoring. • DO NOT apply packing to the vagina. • Be alert for fluid overload when administering fluids. • Consider starting a second IV if the patient is experiencing excessive vaginal bleeding or hypotension. • Transport to an appropriate OB facility if the patient is pregnant. Abortion/Miscarriage • The patient may be complaining of cramping, nausea, and vomiting. • Be sure to gather any expelled tissue and transport it to the receiving facility. • Signs of infection may not be present if the abortion/miscarriage was recent. • An abortion is any pregnancy that fails to survive over 20 weeks. When it occurs naturally, it is commonly called a” miscarriage.” Abruptio Placenta • Usually occurs after 20 weeks. • Dark red vaginal bleeding. • May only experience internal bleeding. • May complain of a “tearing” abdominal pain Ectopic Pregnancy • The patient may have missed a menstrual period or had a positive pregnancy test. • Acute unilateral lower abdominal pain that may radiate to the shoulder. • Any female of childbearing age complaining of abdominal pain is considered to have an ectopic pregnancy until proven otherwise. Pelvic Inflammatory Disease • Be tactful when questioning the patient to prevent embarrassment. • Diffuse back pain. • Possibly lower abdominal pain. • Pain during intercourse. • Nausea, vomiting, or fever. • Vaginal discharge. • May walk with an altered gait due to abdominal pain. Placenta Previa • Usually occurs during the last trimester. • Painless. • Bright red vaginal bleeding. Post Partum Hemorrhage • Post partum blood loss greater than 300-500 ml. • Bright red vaginal bleeding. • Be alert for shock and hypotension. Uterine Inversion • The uterine tissue presents from the vaginal canal. • Be alert for vaginal bleeding and shock. PreEclampsia/Eclampsia • Severe headache, vision changes, or RUQ pain may indicate pre - eclampsia. • In the setting of pregnancy, hypertension is defined as a BP greater than 140 systolic and greater than 90 diastolic, or a relative increase of 30 systolic and 20 diastolic from the patient's normal (pre-pregnancy) blood pressure. Uterine Rupture • Often caused by prolonged, obstructed, or non-progressive labor. • Severe abdominal pain. Vaginal Bleeding • If the patient is experiencing vaginal bleeding, DO NOT pack the vagina, pad on outside only. CHILDBIRTH / OBSTETRICAL EMERGENCIES UNCOMPLICATED DELIVERY UNIVERSAL PATIENT CARE PROTOCOL Observe Head Crowning Contact Medical Control to Notify of Delivery Prepare Patient for Delivery Set-Up Equipment IV Protocol if Time Run Normal Saline at 150 ml/hour Delivery of Head Firm, gentle pressure with flat of hand to slow expulsion. Allow head to rotate normally, check for cord around neck, and wipe face free of debris. Suction mouth and nose with bulb syringe. Delivery of Body Place one palm over each ear with next contraction gently move downward until upper shoulder appears. Then lift up gently to ease out lower shoulder Support the head and neck with one hand and buttocks with other. REMEMBER THE NEWBORN IS SLIPPERY Newborn and Cord Keep newborn at level of vaginal opening. Keep warm and dry. After 10 seconds, clamp cord in two places with sterile equipment at least 6-8” from newborn. Cut between clamps. Allow placenta to deliver itself but do not delay transport waiting. DO NOT PULL ON CORD TO DELIVER PLACENTA. Take placenta to hospital with patient. CONTACT MEDICAL CONTROL TRANSPORT B EMT – B B I P M EMT – I EMT – P MED CONTROL I P M Facilitator’s Guide CHILDBIRTH / OBSTETRICAL EMERGENCIES UNCOMPLICATED DELIVERY CONTACT MEDICAL CONTROL IMMEDIATELY WHEN DELIVERY IS IMMINENT SIGNS AND SYMPTOMS DIFFERENTIAL DIAGNOSIS HISTORY • • • • • • • Due date Time contractions started / how often Rupture of membranes Time / amount of any vaginal bleeding Sensation of fetal activity Past medical and delivery history Medications • • • • • • Spasmotic pain Vaginal discharge or bleeding Crowning or urge to push Meconium Left lateral position Inspect perineum (No digital vaginal exam) • • • Abnormal presentation • Buttock • Foot • Hand • Prolapsed cord Placenta previa Abruptio placenta KEY POIN TS • • • • • • • • • • • Exam (of Mother): Mental Status, Heart, Lungs, Abdomen, Neuro. Document all times (delivery, contraction frequency, and length). If maternal seizures occur, refer to the Obstetrical Emergencies Protocol. After delivery, massaging the uterus (lower abdomen) will promote uterine contraction and help to control post-partum bleeding. Some perineal bleeding is normal with any childbirth. Large quantities of blood or free bleeding are abnormal. Prepare to deliver on scene (protecting the patient’s privacy). If delivery becomes imminent while enroute, stop the squad and prepare for delivery. Newborns are very slippery, so be careful not to drop the baby. There is no need to wait on scene to deliver the placenta. If possible, transport between deliveries if the mother is expecting twins. Allow the placenta to deliver, but DO NOT delay transport while waiting. DO NOT PULL ON THE UMBILICAL CORD WHILE PLACENTA IS DELIVERING. ] Facilitator’s Guide Activity: Individual work to review signs and symptoms associated with the most common causes of PPH. Mini Mini case case studies studies AT3-15 AT3-15 • Find learning activity 2: Assessing excessive vaginal • Find learning activity 2: Assessing excessive vaginal bleeding after childbirth, found in the classroom bleeding after childbirth, found in the classroom learning activities for Additional Topic 3: Managing learning activities for Additional Topic 3: Managing complications during the third stage of labor in the complicationsNotebook. during the third stage of labor in the Participant’s Participant’s Notebook. • Read through each mini case study and decide on • Read through each mini case study and decide on the most probable cause of each woman’s the most probable cause of each woman’s postpartum hemorrhage. postpartum hemorrhage. • You may refer to Table 8 in Additional Topic 3: • You may refer to Table 8 in Additional Topic 3: Managing complications during the third stage of Managing during the third stage of labor in thecomplications Reference Manual. labor in the Reference Manual. Notes to the facilitator: • Ask participants to turn to classroom learning activity 2: Assessing excessive vaginal bleeding after childbirth for Additional Topic 3: Managing complications during the third stage of labor in the Participant’s Notebook. • They should also refer to Table 8 in Additional Topic 3 in the Reference Manual. • Give participants 5 minutes to read the mini case studies and write in their answers. Notes to the facilitator: • After they have had time to review the mini case studies, put the correct answers up (remember that the answer provides the MOST probable diagnosis). • Ask participants if their answers agree with yours. Facilitate a discussion if there are questions about the probable diagnosis. • Answer any questions. Mini Mini case case studies studies Answers Answers •• Ms. Ms. A: A: Retained Retained placenta placenta •• Ms. Ms. B: B: Genital Genital lacerations lacerations •• Ms. Ms. C: C: Cervical Cervical tear tear •• Ms. Ms. D: D: Retained Retained placental placental fragments fragments ++ uterine atony uterine atony •• Ms. Ms. E: E: Inverted Inverted uterus uterus •• Ms. Ms. F: F: Uterine Uterine atony atony AT3-16 AT3-16 Facilitator’s Guide Flipchart / Overhead / PowerPoint slides 17 and 18 Time: 15 min. Activity: Illustrated lecture to review management of uterine atony. Objective: Describe the immediate medical management of the woman whose uterus does not contract adequately. Notes to the facilitator: • Ask participants to turn to the section What if the uterus does not adequately contract? in Additional Topic 3 of the Reference Manual and refer to management of uterine atony. • Present the steps to follow when a woman presents with uterine atony (if possible, perform a simulation of the steps as presented in the Reference Manual). • Remind participants that uterine atony is the leading cause of PPH. Uterine Uterine Atony: Atony: Management Management •• Continue Continue to to massage massage the the uterus uterus •• Use Use uterotonic uterotonic drugs drugs • Perform bimanual • Perform bimanual compression compression • Perform aortic • Perform aortic compression compression • Surgical management • Surgical management AT3-17 AT3-17 At At all all times: times: ••Anticipate Anticipate need need for for blood blood and and transfuse transfuse as necessary. as necessary. • Consider other • Consider other causes / contributing causes / contributing factors – genital factors – genital lacerations, retained lacerations, retained placenta, clotting placenta, clotting disorder. disorder. Packing the uterus is ineffective and Packingwastes the uterus is ineffective and precious time. wastes precious time. • Emphasize that uterine atony may coexist with genital lacerations, retained placental fragments, retained placenta, and clotting disorders. • Emphasize that packing the uterus is ineffective and wastes precious time. Notes to the facilitator: • Review uterotonic drugs to administer to manage uterine atony (see Table 9 in the Reference Manual). Uterotonics for treatment of PPH Oxytocin Dose and route IV: Infuse 20 units in 1 L IV fluids at 60 drops per minute Ergometrine IM: give 0.2 mg AT3-18 Misoprostol 1,000 mcg rectally IM: 10 units Continuing dose IV: Infuse 20 units in 1 L IV fluids at 40 drops per minute Maximum dose Not more than 3 L of IV fluids containing oxytocin Repeat 0.2 mg IM after 15 minutes If required, give 0.2 mg IM every 4 hours 5 doses (total 1.0 mg) Not known Oral dose should not exceed 600 mcg because of risk of fever Facilitator’s Guide Activity: Demonstration of a bedside clotting test. Notes to the facilitator: • Demonstrate how to perform a bedside clotting test to rule out a blood clotting disorder. • Remind participants that they should also consider the possibility that the woman has a clotting disorder any time a woman has PPH. Bedside Bedside clotting clotting test test AT3-19 AT3-19 •• Take Take 22 mL mL of of venous venous blood blood into into aa small, small, dry, dry, clean clean plain plain glass glass test test tube tube (approximately (approximately 10 10 mm mm xx 75 75 mm). mm). •• Hold Hold the the tube tube in in your your closed closed fist fist to to keep keep itit warm warm (+37° (+37°C). C). •• After After 44 minutes, minutes, tip tip the the tube tube slowly slowly to to see see ifif aa clot clot is is forming. forming. Then Then tip tip itit again again every every minute minute until until the the blood blood clots clots and and the the tube tube can can be be turned turned upside upside down. down. •• Failure Failure of of aa clot clot to to form form after after 77 minutes minutes or or aa soft soft clot clot that that breaks breaks down down easily easily suggests suggests aa blood-clotting blood-clotting disorder. disorder. Flipchart / Overhead / PowerPoint slides 20 and 21 Time: 20 min. Activity: Demonstration and return demonstration of bimanual compression of the uterus. Notes to the facilitator: • Ask participants to stand around the model to observe the demonstration of internal bimanual uterine compression. Make sure that everyone can see. Internal Internal bimanual bimanual compression compression • Follow steps for internal bimanual uterine compression as listed in the Reference Manual. Ask participants to refer to the Reference Manual and follow along as you provide the demonstration. • Ask for questions before proceeding. Repeat any steps that may be unclear. • Give participants time to practice internal bimanual uterine compression on the obstetric model. AT3-20 AT3-20 Managing Managing complications complications in inpregnancy pregnancy and and childbirth. childbirth. W WHO. HO. 2003 2003 Facilitator’s Guide Activity: Demonstration and return demonstration of aortic compression. Notes to the facilitator: • • Ask participants to stand around the model to observe the demonstration of aortic compression. Make sure that everyone can see. Follow steps for aortic compression as listed in the Reference Manual. Ask participants to refer to the Reference Manual and follow along as you provide the demonstration. Aortic Aortic compression compression AT3-21 AT3-21 Managing Managing complications complications in inpregnancy pregnancy and andchildbirth. childbirth. WHO. WHO. 2003 2003 • Ask for questions before proceeding. Repeat any steps that may be unclear. • Give participants time to practice aortic compression on the obstetric model. Flipchart / Overhead / PowerPoint slide 22 Time: 20 min Activity: Small group work to review management of genital tears, retained placental fragments, retained placenta. Objective: Describe the immediate medical management of the woman whose uterus does not contract adequately. Notes to the facilitator: Small Small Group Group Work Work AT3-22 AT3-22 •• Group Group 1: 1: Develop Develop aa job job aid aid that that describes describes management management of of genital genital tract tract tears tears (refer (refer to to Additional Additional Topic Topic 33 in in the the Reference Reference Manual). Manual). •• Group Group 2: 2: Develop Develop aa job job aid aid that that describes describes management management of of retained retained placenta placenta (refer (refer to to Additional Additional Topic Topic 33 in in the the Reference Reference Manual). Manual). •• Group Group 3: 3: Develop Develop aa job job aid aid that that describes describes management management of of retained retained placental placental fragments fragments (refer (refer to to Additional Additional Topic Topic 33 in in the the Reference Reference Manual). Manual). • Divide the group in three smaller groups. Assign each group the task of preparing a job aid that describes management of genital tears (group 1), management of retained placenta (group 2), management of retained placental fragments (group 3). • Give each group 10 minutes to work on their task. • Circulate around the room and assist participants as they work on their task. • Each group should present their job aid to the large group. Facilitator’s Guide Activity: Case study to review management of PPH. Notes to the facilitator: • Divide participants into groups of 3 to 4 people (try to ensure that there is a mix of cadres of providers in each group). • Facilitate group work. • After 20 minutes, facilitate a discussion about the answers in a plenary. Answers to the case study are in the Facilitator’s Guide and the Participant’s Notebook. Small Small Group Group Work Work (Groups (Groups of of 3-4 3-4 people) people) AT3-30 AT3-30 •• Turn Turn to to classroom classroom learning learning activity activity 33 for for Additional Additional Topic Topic 33 in in the the Participant’s Participant’s Notebook. Notebook. •• Carefully Carefully read read the the case case study study and and then then respond to the questions (refer respond to the questions (refer to to Additional Additional Topic Topic 33 in in the the Reference Reference Manual). Manual). 20 minutes 20 minutes •• Discuss Discuss responses responses in in the the plenary. plenary. 10 10 minutes minutes Flipchart / Overhead / PowerPoint slide 31 Time: 60 min. Activity: Clinical simulation to summarize key points in the session. Clinical Clinical simulation: simulation: Management Management of of vaginal bleeding after childbirth vaginal bleeding after childbirth AT3-31 AT3-31 Notes to the facilitator: • Refer to the Facilitator’s Guide for instructions on how to facilitate the clinical simulation. • Answers for the clinical simulation are on the pages following instructions for facilitating the clinical simulation. • The questions, without the answers, are located in the Participant’s Notebook. Facilitator’s Guide Flipchart / Overhead / PowerPoint slide 32 Notes to the facilitator: • Encourage participants to work on learning activities found in the Participant’s Notebook for Additional Topic 3. • Participants may work individually or in groups on the learning activities during breaks, in the evening, or in the clinical area when there are no clients. • Participants may correct their learning activities by referring to suggested answers found in the Participant’s Notebook. Facilitators should make themselves available to work with the participants to review answers for learning activities. Learning activities AT3-32 • Please complete learning activities found in the Participant’s Notebook for Additional Topic 3 • You may work individually or in groups on the learning activities during breaks, in the evening, or in the clinical area when there are no clients • You may correct your answers individually or with another participant or the facilitator. • See a facilitator if you have questions. Uterine atony: uterus soft and relaxed Treat for whole retained placenta If whole placenta still retained ■ Manual removal with prophylactic antibiotics Treat for retained placenta fragments If bleeding continues ■ Manage as uterine atony Lower genital tract trauma: excessive bleeding or shock contracted uterus Treat for lower genital tract trauma ■ Repair of tears ■ Evacuation and repair of haematoma If bleeding continues ■ Tranexamic acid Uterine rupture or dehiscence: excessive bleeding or shock Treat for uterine rupture or dehiscence ■ Laparotomy for primary repair of uterus ■ Hysterectomy if repair fails If bleeding continues ■ Tranexamic acid Uterine inversion: uterine fundus not felt abdominally or visible in vagina Treat for uterine inversion ■ Immediate manual replacement ■ Hydrostatic correction ■ Manual reverse inversion (use general anaesthesia or wait for effect of any uterotonic to wear off ) Clotting disorder: bleeding in the absence of above conditions Treat for clotting disorder ■ Treat as necessary with blood products Placenta not delivered Placenta delivered incomplete Be ready at all times to transfer to a higher-level facility if the patient is not responding to the treatment or a treatment cannot be administered at your facility. Start intravenous oxytocin infusion and consider: • uterine massage; • bimanual uterine compression; • external aortic compression; and • balloon or condom tamponade. Transfer with ongoing intravenous uterotonic infusion. Accompanying attendant should rub the woman’s abdomen continuously and, if necessary, apply mechanical compression. Oxytocin – treatment of choice ■ Oxytocin ■ Controlled cord traction ■ Intraumbilical vein injection (if no bleeding) ■ Oxytocin ■ Manual exploration to remove fragments ■ Gentle curettage or aspiration Ergometrine – if oxytocin is unavailable or bleeding continues despite oxytocin If laparotomy correction not successful ■ Hysterectomy Prostaglandins – if oxytocin or ergometrine are unavailable or bleeding continues despite oxytocin and ergometrine Tranexamic acid • 20–40 IU in 1 litre of intravenous fluid at 60 drops per minute, and 10 IU intramuscularly • Continue oxytocin infusion (20 IU in 1 litre of intravenous fluid at 40 drops per minute) until haemorrhage stops Section II: The following are laminated and displayed in a common area that is readily accessible to physicians, nurse midwives, nurses, and other staff who might need the information: ____WAPC “Algorithm for Postpartum Hemorrhage” ____WAPC list of “Uterotonic Agents for Postpartum Hemorrhage” ____Diagram of the B-Lynch compression suture technique Oxytocin for Postpartum Hemorrhage Protocol revised October 2008 Preamble One of the associated risks associated with childbirth is a postpartum hemorrhage. In the out-of-hospital setting, early intervention to manage a significant and ongoing hemorrhage can prevent further blood loss. Oxytocin helps contract uterine smooth muscle and minimizes further uterine blood loss. Requirements 1. Fully licensed Technician-Paramedic. 2. Certification in postpartum hemorrhage protocol by the Medical Director. 3. Certification in administration of intramuscular (IM) medication by the Medical Director. Indications 1. Patients at greater than 20 weeks gestation who have delivered a newborn in the outofhospital environment. and 2. Patients experiencing postpartum hemorrhage of greater than 500 ml blood. Contraindications 1. Patient has not completed delivery of fetus(es). 2. Patient is less than 20 weeks gestation. Oxytocin for Postpartum Hemorrhage Protocol Drug Doses and Frequencies oxytocin IM: 10 IU after the newborn has delivered IV: in the event of ongoing with significant blood loss, an additional 40 IU can be added to each 1000 ml normal saline and infused based on the severity of hemorrhage and patient response Procedure 1. Perform patient assessment and record vital signs. 2. Assess that patient meets criteria for this protocol. 3. Ensure there are no contraindications to use of this protocol. 4. Initiate basic life support treatment measures, including supplemental oxygen. - these take precedence over management using this protocol 5. Initiate an intravenous line with normal saline - add oxytocin to the intravenous bag - infuse at a rate based on severity of hemorrhage and patient condition 6. Manage the hemorrhage as per appropriate guideline or protocol. 7. While basic life support treatment measures and intravenous line are being initiated, and hemorrhage is being controlled, obtain a focused obstetrical history. Include the following details: · antenatal care · expected delivery date · history of current pregnancy (including results of any ultrasounds) · history of prior pregnancies (including history of previous difficulties) 8. If baby (last baby), but not placenta, has delivered: · provide appropriate care for mother and newborn · give mother oxytocin IM · assist with delivery of placenta · manage complications, if possible, as per appropriate guideline or protocol · initiate transport to hospital Oxytocin for Postpartum Hemorrhage Protocol 3 9. If the baby (last baby) and placenta have delivered: · provide appropriate care for mother and newborn · give mother oxytocin IM if not already done as part of step 8 · manage complications, if possible, as per appropriate guideline or protocol · initiate transport to hospital 10.If possible, encourage mother to empty her bladder. 11.Massage the uterine fundus to promote uterine contraction and lessen the severity of the hemorrhage. 12.Repeat assessment, including vital signs, level of consciousness, oxygen saturation, and effect of oxytocin. Documentation Requirements The following information must be documented on the patient care report form: 1. Patient’s presenting signs and symptoms, including vital signs. 2. Indications for protocol use. 3. Details of patient’s obstetrical history and current delivery. 4. Dose, route, and time for each oxytocin dose used, and resulting clinical effects. 5. Repeat assessment and vital signs, as indicated. 6. Changes from baseline, if any, that occur during treatment or transport. 7. Signature and license number of EMS personnel performing any transfer of function skills. Certification Requirements 1. Attend in-depth classes and lectures on obstetrics and obstetrical emergencies. 2. Demonstrate an understanding of the pharmacology, mechanism of action, and potential side effects of oxytocin. 3. Do an acceptable clinical rotation on a labour and delivery ward. Oxytocin for Postpartum Hemorrhage Protocol 4 4. Pass a written examination. 5. Pass practical scenarios incorporating variations of the oxytocin – postpartum hemorrhage protocol. 6. Certification is by the Medical Director. Recertification Requirements 1. Review class and recertification is done every 12 months. 2. A record will be kept to document all cases where this protocol is used. Decertification 1. Decertification is at the discretion of the Medical Director or the Provincial Medical Director, Emergency Medical Services, Manitoba Health & Healthy Living. Quality Assurance Requirements 1. Appropriate quality assurance policies must be in place. The Medical Director or designate must review all instances where this protocol is used. As a minimum, the following must be assessed: i) appropriateness of implementation ii) adherence to protocol iii) any deviation from the protocol iv) corrective measures taken, if indicated 2. Yearly statistics for protocol use compiled and forwarded to Emergency Medical Services, Manitoba Health & Healthy Living.