Malawi Misoprostol Protocol.

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MISOPROSTOL FOR MANAGEMENT OF INCOMPLETE
ABORTION
A CLINICAL PROTOCOL FOR SERVICE DELIVERY
ACKNOWLEDGEMENTS
To be acknowledged - reviewers, sponsors, etc.
Edgar Kuchingale,
Shirley Lengu
Alick Mazenga
Joachim Osur
Joseph Karanja
Charles Kiggundu
Monica Ogutu
Emily Nakirija
INTRODUCTION
Data and information from various researches indicate that, compared to other countries, Malawi
still has poor reproductive health indicators. One of the indicators is Maternal Mortality Ratio
(MMR). According to Malawi Demographic and Health Surveys (MDHS) the MMR for Malawi
rose from 620 deaths per 100,000 live births (1992) to 1,120 deaths per 100,000 live births (2000)
and declined to 984 deaths per 100,000 live births (2004). The most recent estimates released by
World Health Organization (WHO) and partners have ranked Malawi at 1,100 maternal deaths
per 100,000 live births. Puerperal sepsis contributes 25% of all maternal deaths making it the
number one cause of all maternal deaths in Malawi. Unsafe abortion contributes significantly to
all cases of puerperal sepsis and obstetric haemorhage. Post abortion complications contribute to
about 60% of all admissions to our hospitals.
USE OF MISOPROSTOL IN POST ABORTION CARE
Misoprostol, if used for treatment of incomplete abortion, promises to have an important public
health impact. Women and health care systems world-wide could significantly benefit from this
non-invasive treatment option. In low resource countries, where infection, hemorrhage and
uterine damage are far too commonly reported as consequences of (poor) surgical care,
misoprostol treatment of incomplete abortion would be tremendous step towards reducing
morbidity and mortality due to abortion complications worldwide.
This method promises to greatly improve access to services, by enabling women to seek
appropriate, effective care at secondary and even primary healthcare facilities, with nonsurgically trained, mid- level providers. At the same time, misoprostol for incomplete abortion
and miscarriage could decrease the burden on tertiary health care facilities, and reduce costs to
health care systems worldwide. It could limit the burden on skilled equipment and supplies,
surgical wards, sterilization and anesthesia. Misoprostol treatment also has the additional benefit
of being highly acceptable to women as it is less medicalized and less invasive than standard
surgical treatment.
MISOPROSTOL DRUG
Misoprostol is a stable, widely available and inexpensive prostaglandin analogue, initially
manufactured for use in peptic ulcer disease. Misoprostol however has many uses in obstetrics
and gynaecology (Goldberg et al 2001, WHO 2003). Gynaecological uses include induction of
labour, induction of abortion (as a single agent or in combination with mefeprestone), postpartum haemorrhage and emptying the uterus in cases of incomplete abortion in the first
trimester.
In uterine evacuation in incomplete abortion Misoprostol works by interacting with prostaglandin
receptors and causes the cervix to soften and the uterus to contract, resulting in the expulsion of
the uterine contents.
Misoprostol is a safe and effective alternative to surgical evacuation of the uterus for first
trimester incomplete abortion. The misoprostol alone protocol involves two outpatient clinic
visits.
First Visit
Clinical Assessment
1. Confirm diagnosis of otherwise uncomplicated first trimester incomplete abortion
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Amenorrhea in a woman of reproductive age
Uterus equal to or less than 12 weeks by bimanual examination
Cervix open, POCs felt or reported to have been passed, active vaginal
bleeding
Clinically stable, not in shock, no severe anaemia, no severe uterine
infection
2. If client has any of the following contraindications, Misoprostol should not be
used, and an alternative method of management should be offered:
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Allergy to misoprostol or other prostaglandins
Confirmed or suspected ectopic pregnancy
Unstable haemodynamic status or shock
Signs of pelvic infection and/or sepsis
3. Use caution when
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There is an IUCD in place. Remove before administration of misoprostol
The woman has coagulation problem or other unstable health problem.
Timely uterine evacuation with (e.g. using MVA) with careful monitoring
is preferred.
Counselling – to include:
 All treatment options available
 Their risks and benefits
 What to expect with each method: bleeding, cramping, analgesia, need for follow
up, pain medication provided.
 Medication method of evacuation may take several hours to several weeks to
complete. Most complete within 2 days. Patience, patience, patience, is necessary

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Complications are very rare but can occur. Advise the woman to seek medical
attention immediately if she experiences prolonged heavy bleeding (soaking
through more than 2 pads in an hour), or fever, malaise, and foul-smelling
discharge. Provide information on who to call or where to go if she is concerned.
In the event of the few cases where medication does not work MVA will be
necessary.
Most family planning methods can be started at the time of initiating misoprostol
e.g. the pill, injection, and implant. IUD needs confirmation of completion of
evacuation before it can be started, and can be inserted during the follow up visit.
Inform that fertility returns rapidly after the treatment.
Routine Antibiotic Prophylaxis is not indicated for medication management of
incomplete abortion.
Standard Regimen
1. The current recommended standard regimen is 600 mcg of misoprostol orally
2. Alternative regimen: 400 mcg sublingually. There is as yet less evidence on this
regimen but it may be useful where misoprostol supply is limited. For sublingual
use, the pills are placed under the tongue for 30 minutes then swallowed.
3. Buccal route may also be effective.
The standard regimen (#1) will be used in this protocol. Three 200mcg tablets of
misoprostol will be administered under direct observation and the woman will be
observed for 30 minutes before she is discharged home. Pain medication e.g. tabs
paracetamol 1000mg or ibuprofen 400mg will be given to the woman to start taking
before clamping starts. She may repeat 6hrly for three days. Other measures include
moving around, verbal support, encouragement, distraction, hot compresses, hot showers,
and/or massage.
PROTOCOL FOR MISOPROSTOL FOR POSTABORTION CARE (M-PAC)
Gestation
Dose
Route
600 mcg
Oral
Up to 12 weeks size
400 mcg
uterus
Timing
Three 200 mcg tablets taken at once
Sublingual First 200 mcg tablets under tongue for
30 minutes, then swallow the
remaining pill.
Effects and Side effects of Misoprostol
1. Bleeding lasts longer than in MVA, lasts 2 weeks of which first 3-4 days heavy
followed by lighter bleeding and spotting.
2. Cramping starts or increases within few hours of misoprostol administration and
is greatest during completion of the abortion. Managed by analgesics.
3. Nausea, vomiting and diarrhea: can occur within the first 4 hours of misoprostol.
Reassurance usually enough but if necessary anti-emetic may be given.
4. Fever and chills: misoprostol increases temperature after administration.
Paracetamol or ibuprofen will decrease the symptoms. A fever greater than 38C
or 100.4F that persists more than 24 hours after administration of misoprostol
may indicate possible infection.
Warning Signs of Complications – inform woman to seek medical care immediately
she notices:
 Bleeding: soaking more than 2 pads in 1 hr, for longer than 2 days; heavy
bleeding that occurs after bleeding had slowed down or stopped; feeling
lightheaded or dizzy after many days of bleeding. Requires stabilization,
MVA, IV fluids and, if necessary, transfusion.
 Infection: fever or chills for more than 24 hours after taking misoprostol,
severe pelvic or abdominal pain that lasts for a long time, foul smelling or
purulent vaginal discharge, marked fundal tenderness. Requires
broadspectrum parenteral antibiotic combination e.g. inj penicillin,
gentamycin and metronidazole or a cephalosporin and metronidazole.
 Failure of medication management: Persistent bleeding/cramping not
improved by the time of follow up visit. Requires MVA.
Follow up visit
This is scheduled 2 weeks following misoprostol. Confirm complete expulsion by
history, and bimanual examination. Symptoms and signs of completion include:
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Normal uterine size
Absence of uterine tenderness
Closed cervical os
Woman’s report of the expulsion process
Minimal or absent bleeding
Resolution of cramping
Failure of medication management is indicated by
 Persistent bleeding/clamping not improved by the time of follow up visit
 Open cervical os
Persistent incomplete abortion should be evacuated by MVA.
Make sure the woman had a family planning method, if not counsel and provide a
method.
Women will be referred for ultrasound only for clear indications such as inability to
determine completeness clinically; suspicion of ectopic pregnancy, adnexal masses,
uterine masses (e.g. fibroids).
SUMMARY OF MISO-PAC PROTOCOL
FIRST VISIT (DAY 1)
 Confirm diagnosis of incomplete abortion and clinical stability
 Confirm woman is suitable for evacuation with misoprostol
 Counsel fully and appropriately; Initiate contraception if needed
 Administer 3 tablets of misoprostol 200mcg (= 600mcg total) orally. Give
pain medication at the same time (Brufen or other NSAID)..
 Observe for 30 min and confirm there is no undue effect
 Give analgesics to take home
 Inform who to call or where to go in case of warning signs or complications.
 Give return date
FOLLOW UP VISIT (DAY 7-14)
 Confirm complete expulsion by history and physical (bimanual) examination
 Manage persistent incomplete abortion by MVA
 Treat any complications as appropriate
 Resolve any doubts with ultrasonography
 Continue counseling and provide contraception as appropriate
 Link with other RH and support services
REFERENCES
1. Karanja JG: Misoprostol for management of incomplete abortion Kenyan
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http://www.unfpa.org/publications/detail.cfm?ID=343. Accessed on October
19, 2007.
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9. DaoB, BlumJ, ThiebaB, RaghavanS, OuedraegoM, LankoandeJ, Winikoff B.
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10. Weeks A, Alia G, Blum J, Ekwaru P, Durocher J, Winikoff B, et al.A
randomized trial of oral misoprostol versus manual vacuum aspiration for the
treatment of incomplete abortion in Kampala, Uganda.Obstet Gynecol
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11. Gynuity Health Projects: Medical Abortion in developing Countries. N.Y.
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