Intrauterine Contraception; A Method That Will Prevail! IUC/EMB/PCB Patty Cason, MS, FNP-BC UCLA School of Nursing Disclosure • • • • • Expert Input Forum HPV Vaccine; Merck Speaker Merck; Gardasil, NuvaRing Trainer Merck; Nexplanon, Implanon Advisory board; ParaGard Teva Speaker & trainer; ParaGard Teva Outline • • • • Attributes of LARC Methods Characteristics of the IUC’s Reducing barriers to IUC use Management of side effects and complications • Step-by step insertion • Tips for difficult insertions 3 “Politically Correct” Terminology Old name • IUD: Intrauterine Device New names • IUC: Intrauterine Contraception – Applied to Cu-T380 (ParaGard®) – Generic term for both types • IUS: Intrauterine System – Applied to LNG-IUC (Mirena®) 4 The Case for LARC Methods • More than 1/3 of all U.S. women will have had an induced abortion by age 45 • 20% of women selecting sterilization at age < 30 years later express regret • Need for effective contraceptive methods that are “forgettable” Henshaw. Fam Plann Perspect 1998 Hillis et al. Obstet Gynecol 1999 Stanwood, NL. Obstet Gynecol 2002 5 U.S. Pregnancies: Unintended vs. Intended Intended 51% Unintended 49% Unintended births 22.5% Elective Abortions Henshaw: Fam Plann Perspect 1998;30:24-29. 26.5% 6 Contraceptive Use During Month of Unintended Pregnancy 43% used contraception 5% consistent method use: method failure 52% did not use contraception Guttmacher Institute In Brief Series 1 2008. 7 What are LARC Methods? • Long Acting Reversible Contraception – IUCs: LNG-IUC ,Cu-T380 – Implants: Etonogestrel Implant • Long term continuous protection 24/7/365 protection… for 3-10 years • Do not require episodic patient initiative for use • Not daily • Not weekly • Not monthly • Not even every 12 weeks 8 Why LARC Methods? • • • • • • • • • They are “forgettable” Require just one motivational act The most effective reversible methods available Superior continuation rates Are among the safest contraceptive methods…very few US-MEC category 3 or 4 grades Highest patient satisfaction among methods No need to take time to refill prescriptions An alternative to surgical sterilization The most cost saving method of contraception 9 Contraceptive Efficacy Top Tier: Most Effective Female/male sterilization; IUC, Implant Middle Tier: Effective DMPA, Oral Contraceptive (OC), Patch, Ring Bottom Tier: Less Effective Barriers, Spermicides, Behavioral methods 10 Contraceptive Effectiveness and Continuation Rates Implant (Implanon) Male sterilization IUC •LNG-IUC (Mirena) •Cu-T 380 (ParaGard) Female sterilization DMPA OCs, Patch, Ring Perfect Use 0.05 0.10 Typical Use 0.05 0.15 Continuation rate 84% 100% 0.2 0.6 0.5 0.3 0.3 0.2 0.8 0.5 3.0 8.0 80% 78% 100% 56% 68% Hatcher, RA et al; Contraceptive Technology 19th Edition,: 2007 11 Cost savings per dollar expenditure by contraceptive method, Family PACT 2003 Foster, D. G. et al. Am J Public Health 2009;99:446-451 12 Intrauterine Contraception in the U.S. Mechanism Copper T-380 LNG-IUC Spermicidal effect of copper Up to 10 years 0.8 failures/hwy No hormones None Thickening of cervical mucus Up to 5 years 0.2 failures/hwy Less bleeding Menorrhagia Menstrual pain $703 Duration Efficacy Benefit Noncontraceptive use Cost (retail) $598/568 13 Client Choice of IUC Type • LNG IUC • Copper T IUC – Good method for –Good method women who for women request less who don’t menstrual flow or want who experience hormonal dysmenorrhea contraception 14 Copper T IUC: Mechanism of Action • Primary mechanism is prevention of fertilization – Reduce motility and viability of sperm – Inhibit development of ova • Inhibition of implantation is a secondary mechanism Alvarez F, Brache V, Fernandez E, et al. Fertil Steril. 1988;49:768 Segal SJ, Alvarez-Sanchez F, et al. Fertil Steril. 1985;44:214. ACOG. Statement on Contraceptive Methods, Washington DC:ACOG, July 1998 Rivera R, Yacobson I, Grimes D, Am J Obstet Gynecol 1999;181:1263-9 15 Stanford JB, Mikolajczyk RT, Am J Obstet Gynecol 2002; 187:1699-708 LNG-IUC Physical Characteristics Steroid reservoir levonorgestrel 20 g/day 16 LNG-IUC: Contraceptive Mechanism • Cervical mucus thickened • Sperm motility and function inhibited • Endometrium suppressed • Ovulation inhibited (in some cycles) Jonsson et al. Contraception 1991;43:447 Videla-Rivero et al. Contraception 1987;36:217 Rivera R, Yacobson I, Grimes D, Am J Obstet Gynecol 1999;181:1263-9 Stanford JB, Mikolajczyk RT, Am J Obstet Gynecol 2002; 187:1699-708 17 Plasma concentrations (pg/mL) Plasma Concentrations of Levonorgestrel 3000 2500 2000 1500 1000 500 0 MIRENA Implant Nilsson et al. Acta Endocrinol 1980;93:380 Diaz et al. Contraception 1987;35:551 Mini-pill Combined OCs 18 Meta-Analysis: Mirena® vs. Ablation for Heavy Menstrual Bleeding • No difference between rates of treatment failures – 21.2% LNG-IUC vs. 17.9% endometrial ablation • Both resulted in similar improvements in quality of life • Less need for analgesia/anesthesia in LNG-IUC group • Ablation requires additional effective contraception Kaunitz, et al. OG. 2009 May;113(5):1104-16b. 19 So….if IUCs are so good… Why Aren’t They Used More Frequently in the US? 20 Contraception by Age (2008) 60 49 50 40 IUD Steriliz OCP Ring 30 20.7 18.8 20 10 20.9 12.5 2.1 0.9 2.2 4.4 1.9 3.8 0.5 0 15-24 25-34 35-44 Mosher WD. National Survey of Family Growth. Series 23, Number 29 August 2010 21 Increased Use of Intrauterine Contraception in California, 1997 to 2007 • Modern intrauterine contraception is safe and highly effective, but is used by fewer than 4% of women in the United States. • Previously recommended only for women with at least one child, now recommended for most women regardless of parity or age. • 10 years of the California Women's Health Survey Thompson KM, et al. Womens Health Issues. 2011 Increased Use of Intrauterine Contraception in California, 1997 to 2007 • Use of IUC in California almost doubled over the study period from 4.0% to 7.2% • Women with the greatest increases were: – – – – younger born in the US without a college degree Asian • IUC use among nulliparous women did not increase and IUC users were 71% less likely to be nulliparous Thompson KM, et al. Womens Health Issues. 2011 Increased Use of Intrauterine Contraception in California, 1997 to 2007 CONCLUSION: • IUC use in California is higher than the national average and growing • Disproportionately low use among nullips • Efforts to inform women of IUC's effectiveness and safety, as well as efforts to ensure that health care providers have the necessary clinical skills, are timely and important. Thompson KM, et al. Womens Health Issues. 2011 Why is the IUC Underutilized in the United States? • Dearth of trained and willing professionals to insert devices • Negative publicity about method in ’70s • Misconceptions by health care providers and the public • Fear of litigation Weir. CMAJ 2003 Stanwood, NL. Obstet Gynecol 2002 Steinauer JE. Family Planning Perspectives 1997 25 Family PACT Provider Practices With IUCs • Survey of 1,246 providers with at least one IUC insertion claim in 2005; response rate 65% (n=813) • Providers who think an IUC should not be inserted in clients if: – Nulliparous: 50% – Adolescent: 58% – History of ectopic pregnancy: 63% • Provider’s concern about PID affected willingness to recommend IUC – “A lot” (29%) – “Some” (61%) Harper C, et. al. OB GYN 2008 26 IUC Use By Female Ob/Gyns vs. All Women in the U.S. 50 % of population 40 30 20 18% 10 0.7% 0 Female Ob/Gyn Physicians General Population Population Reference Bureau, 2002.; The Gallup Organization, 2004. 27 Why is the IUC Underutilized in the United States? • Dearth of trained and willing professionals to insert devices • Misconceptions by health care providers and the public • Negative publicity about method in ’70s • Fear of litigation Weir. CMAJ 2003 Stanwood, NL. Obstet Gynecol 2002 Steinauer JE. Family Planning Perspectives 1997 28 Rate of PID by Duration of IUC Use n=20,000 women. 10 8 Rate per 1000 Woman-Years 6 Baseline PID risk: 1-2 cases /TWY 4 2 0 20 days 21 days - 8 years Duration of Use Adapted from Farley T, et al. Lancet. 1992;339:785-788. 29 IUCs Do Not Cause PID • PID incidence for IUC users is similar to that of the general population • Risk is increased only during the first month after insertion • Preexisting STI at time of insertion, not the IUC itself, increases risk • No reason to restrict use based on sexual behaviors Svensson L, et al. JAMA. 1984. Sivin I, et al. Contraception. 1991. Farley T, et al. Lancet. 1992. Grimes DA, Lancet 2000. Hubacher D, et al. Engl J Med 2001 30 Why is the IUC Underutilized in the United States? • Dearth of trained and willing professionals to insert devices • Misconceptions by health care providers and the public • Negative publicity about method in ’70s • Fear of litigation Weir. CMAJ 2003 Stanwood, NL. Obstet Gynecol 2002 Steinauer JE. Family Planning Perspectives 1997 31 Dalkon Shield 32 Dalkon Shield- multi-filament string 33 Fertility Rates in Parous Women After Discontinuation of Contraceptive 100 Pregnancies (%) 80 IUC 60 OC Diaphragm 40 Other methods 20 0 0 12 18 24 30 Months After Discontinuation Vessey MP, et al. Br Med J. 1983. Andersson K, et al. Contraception. 1992. Belhadj H, et al. Contraception. 1986. 36 42 34 Use of the levonorgestrel releasingintrauterine system in nulliparous women To evaluate the insertion procedure and continuation rates of the levonorgestrel releasing-intrauterine system (LNG-IUS) in nulliparous women who, due to fear of complications, are often denied this very effective contraceptive method. Marions L, et al. Eur J Contracept Reprod Health Care. 2011 Use of the levonorgestrel releasingintrauterine system in nulliparous women • The insertions were considered easy by 72% of inserters * • Only 5% of pts were dissatisfied • No perforations • No pregnancies CONCLUSION: Our results support the current practice in Sweden of offering LNG-IUS routinely to nulliparous women * mostly carried out by midwives Marions L, et al. Eur J Contracept Reprod Health Care. 2011 US Medical Eligibility Criteria Category Definition Recommendation 1 No restriction in contraceptive Use the method use 2 Advantages generally outweigh theoretical or proven risks More than usual follow-up needed 3 Theoretical or proven risks outweigh advantages of the method Clinical judgment that this patient can safely use 4 The condition represents an Do not use the unacceptable health risk if the method method is used 38 Indications for IUC Use • Both IUC products – Long term contraception in fertile women • 2010 US Medical Eligibility Criteria Menarche to age 20 Category-2 Age 20 and older Category-1 Nulliparity Category-2 Parous Category-1 39 SFP on Nullips Lyus R, Lohr P, Prage S, Board of the Society of Family Planning. Use of the Mirena LNG-IUS and Paragard CuT380A intrauterine devices in nulliparous women. Contraception 2010;81:367–71 Both IUC Products: US MEC 2010 Category 4 Distorted uterine cavity Post-partum endometritis Post-abortion endometritis Malignant GTD or ↑ hCG Cervical/endometrial cancer Current GC/CT/purulent cervicitis/PID − Initiate: 4; Continue: 2 Pelvic TB − Initiate: 4; Continue: 3 Category 3 Postpartum (48h-4 wk) Benign GTD with ↓ hCG Increased risk of STIs −Initiate**: 2/3; Continue: 2 ** very high individual risk of exposure to GC or Ct is 3 US Medical Eligibility Criteria 2010 LNG-IUS only Copper IUC only Category 4 Category 3 Current Breast cancer (> 5 yrs NED) breast Liver tumors, severe cirrhosis cancer Current MI or angina Migraines with aura AIDS (ARV drug interactions) Complicated transplant Lupus with anti-PL antibody Lupus with thrombocytopenia Timing of Insertion of Intrauterine Contraception Timing With menses Any time Emergency contraception (Cu T only) Pros • Ensures patient not pregnant • Convenience • Low expulsion rate • Pregnancy prevention • Convenience Alvarez PJ. Ginecol Obstet Mex. 1994. O’Hanley K, et al. Contraception. 1992. Cons • Scheduling •Interim pregnancy •Must exclude pregnancy •Not cost effective if used only for EC 43 Copper T380A intrauterine device for emergency contraception: a prospective, multicentre, cohort clinical trial. • Eighteen family planning clinics in China • 1963 women requesting EC within 120 hours of unprotected intercourse. • followed at 1, 3 and 12 months after insertion of CuT380A. • No pregnancies occurred prior to or at the first followup visit, making CuT380A 100% effective as emergency contraception in this study. Wu S, et al. BJOG 2010 Copper T380A intrauterine device for emergency contraception: a prospective, multicentre, cohort clinical trial. • The pregnancy rate over the 12-month period was 0.23 per 100 women • 1.5% women experienced a difficult IUD insertion – requiring local anesthesia or prophylactic antibiotics. • No uterine perforations occurred. • The 12-month postinsertion continuation rate was 94.0 per 100 woman-years. • CuT380A is a safe and effective method for emergency contraception. The advantages of CuT380A include its ability to provide effective, long-term contraception. Wu S, et al. BJOG 2010 A survey of women obtaining EC: are they interested in using the Cu IUD? • 34.0% of 941 said they would be interested in an EC method that was long term, highly effective and reversible. • Interested women were not significantly different from non-interested women in relation to age, marital status, education, household income, gravidity, previous abortions, previous STIs or relationship status. • 37.5% of those interested or 12.8% of all those surveyed would wait an hour, undergo a pelvic exam to get the method and would still want the method knowing it was an IUD. • Only 12.3% of these women could also pay $350 or Turok DK, et al. Contraception. 2011 more for the device. A pilot study of the Copper T380A IUD and oral levonorgestrel for emergency contraception. • (60%) chose oral LNG and (40%) chose the copper IUD. Turok DK, et al. Contraception. 2010 Postpartum IUC Insertion US MEC 2010 •Vaginal delivery or C/S LNG-IUS Cu-IUD •Breast-feeding or non-lactating <10 min after delivery of placenta 2 1 10 min after delivery of placenta to <4 wks 2 2 >4 wks post partum 1 1 Puerperal sepsis 4 4 How Is Postpartum IUC Placement Performed? • IUC placement after vaginal delivery – Insert IUC within 10 minutes of placental delivery – Use sponge forceps on cervical lip – 2nd forceps to place IUC at uterine fundus – Cut string flush with external cervical os – Trim strings at postpartum visit How Is Postpartum IUC Placement Performed? • IUC placement at of caesarean section – After delivery of placenta – Manually place IUC at fundus – tuck strings thru cervix – Repair uterus – Trim strings at postpartum visit IUC Use During Lactation • Effectiveness not decreased • No increased risk of – uterine perforation – Expulsion • Decreased insertional pain • Reduced rate of removal for bleeding and pain • LNG comparable to copper T in breastfeeding parameters Chi I-C, et al. Contraception. 1989 Shaamash AH, et al. Contraception. 2005. 51 Post Abortion IUC Insertion (WHO MEC, Cochrane Review) • No difference in complications for immediate versus delayed insertion of an IUC after abortion • There were no differences in safety or expulsions after insertion of an LNG-IUC compared to Cu-IUC • Expulsion slightly greater when inserted after a 2nd trimester vs. a 1st trimester abortion • US Medical Eligibility Criteria 2010 – First trimester abortion: USMEC-1 – Second trimester abortion: USMEC-2 52 Excellent Time for IUC InsertionPost Abortion • Most women ovulate by 21 days post abortion (range 8-37 days) • This is true for 1st trimester, 2nd trimester, medical abortion and spontaneous abortion Sober S, et al. Contraception 2010 Donnet ML, et al. Clin Endocrinol (Oxf) 1990 Cameron IT, et al. Acta Endocrinol 1988 R.P. Marrs, et al. Am J Obstet Gynecol 1979 53 Excellent Time for IUC InsertionPost Abortion • Of 1.3 million abortions annually in US, about half are repeat procedures • 40% of women scheduled for delayed IUC insertion did not return for the procedure • Immediate post-abortal IUC insertion is a safe, effective, practical, and underutilized intervention that can reduce repeat unintended pregnancy and repeat abortion by two-thirds P Bednarek, et al N Engl J Med 2011; 364:2208-2217 M Cremer, et al Contraception 2011; 83:522-527 Stanek AM, et al. Contraception 2009 54 Why Do A Post-Abortion IUC Placement? • Advantages – One procedure rather than two – Less or no pain with insertion, since cervix is dilated – Immediate protection – Reduce repeat unintended pregnancy risk – 2nd visit often delayed or doesn’t occur • Disadvantages – Slightly higher expulsion rate • 2nd tri TAB: 3-10%, 1st trimester TAB: 5-6% • No TAB: 1-4% – Is the decision to use an IUC biased while pregnant? P Bednarek, et al N Engl J Med 2011; 364:2208-2217 M Cremer, et al Contraception 2011; 83:522-527 Intrauterine device insertion after medical abortion • The day a woman presents for verification of a completed medical abortion may be an ideal time to insert intrauterine contraception • 4.1% expulsions • No diagnosed pelvic infections, pregnancies, or uterine perforations • The continuation rate at 3 months was 80%. Betstadt SJ, et al.Contraception. 2011 Pre-IUC Insertion Screening • Evidence supports no routine screening tests – CT, GC: if high risk sexual behaviors or < age 26 and due for annual screening CT – Pregnancy test: only if pregnancy suspected – Pap smear: only if due for a routine Pap • Any indicated screening test can be done on the day of IUC insertion Intrauterine Contraceptives (IUCs), Family PACT Clinical Practice Alert. 2011 Sufrin C, et al. Contraception 2010 Secura G, et al. Am J Obstet Gynecol 2010 Martínez F, et al. Acta Obstet Gynecol Scand. 57 Faúndes A, et al.Contraception 1998 Pre-Insertion Guidelines • Prophylactic antibiotics – No value for routine administration – May reduce PID in high prevalence GC/CT sites • Premedication – NSAID 30-60 minutes before insertion is common, but no effect on pain or discontinuation – Consider paracervical block if history of F, et al. Acta Obstet Gynecol Scand. cervical os orMartínez canal stenosis Lancet. 1998 Apr 4;351(9108):1005-8. Randomised controlled trial of prophylactic antibiotics b 58 Walsh T, Grimes D, Frezieres R, Nelson A, Bernstein L, Cou Is A Follow Up Visit Necessary? • Practices vary • Two studies by WHO in Africa with non-medicated IUCs conclude that a follow-up visit is unnecessary • Arguments Pro: – Detect early asymptomatic expulsion – Further counseling – Medico-legal “standard of practice”? • Arguments con: – Almost all adverse events have symptoms – Patient knows to return if string cannot be felt 59 Post-IUC Insertion Counseling • The client should return if – String cannot be located (use barrier method) – Symptoms of pregnancy – Symptoms of infection • Pain, deep dysparunia, fever, foul discharge – Sudden unexplained pelvic pain occurs – Excessively heavy bleeding 60 Ectopic pregnancy risk when contraception fails. A review. Furlong , Reprod Med. 2002 IUC Removal Post Menopause? • Menopause – Strings seen: remove – No strings: weigh benefit vs. hazard of removal – Tail-less IUC (e.g., stainless steel coil ring) does not require removal unless requested by the client 62 IUCs: Bleeding Days Per Month Days 6 Copper IUC 4 2 LNG-IUC 0 0 4 8 12 16 20 24 Months Luukkainen and Toivonen. 1992;90 63 LNG-IUC: “Resting State” Endometrium • Lower volume of menstrual bleeding – Shorter, lighter menses – Less iron deficiency anemia – Therapeutic for menorrhagia • Less dysmenorrhea – Suppression of endometriosis, adenomyosis BUT… • 3-6 months for full effect on the endometrium • Spotting is common during this time 64 Menstrual Effects of IUCs: LNG-IUC • Hypomenorrhea; intermenstrual bleeding • Management – Exclude PID, pregnancy, coagulopathy – Supplemental estradiol for 2-3 wks – NSAID’s – If persistent bleeding, check for anemia • Remove IUC if abnormal bleeding is unacceptable to patient 65 Menstrual Effects of IUCs: Copper IUC • Heavier or longer menses (or dysmenorrhea) – Exclude PID, pregnancy, coagulopathy – NSAIDs prophylactically WITH FOOD • Pre-emptive use for first 3 cycles • Start before onset or with onset of menses for antiprostaglandin effect – Naproxen sodium 220mg x2 BID (max 1100mg/day) – Ibuprofen 600-800mg TID (max 2400mg/day) – If heavy or persistent bleeding, check for anemia • Remove IUC if bleeding is unacceptable to patient 66 IUCs: Management of Cramping • Mild: recommend NSAIDs • Severe or prolonged – Examine for partial expulsion, perforation, or PID – Remove IUD if severe cramping is unrelated to menses or unacceptable to patient Ms B: “I Faint Easily” • Ms B is a 25 year old G0 P0 woman requesting IUC placement • She states that she has had a number of fainting episodes in the past…most recently at the dentist and another during a HPV vaccine injection • She has told her PCP about this problem…heart auscultation and an ECG were normal. • Are there any special precautions for her IUC placement? 68 Lightheadedness and Syncope: Vasovagal Attack • Mechanism – Due to bradycardia + peripheral vasodilation – AKA: non-cardiogenic syncope, cervical shock • Association with IUC insertion – Syncope in 2% of insertions – Convulsions in 1 per 2,000 insertions – More likely with • Pain with cervical manipulation • Nulliparity • Previous episodes of vaso-vagal fainting • Dehydration or NPO Lightheadedness and Syncope: Vasovagal Attack • Prodromal symptoms – Lightheadedness, diaphoresis, nausea, anxiety • Prodromal physical signs – Facial pallor, yawning, pupillary dilation • Convulsive syncope occasionally follows faint – Seizure-like movements – Rapid recovery with little or no post-ictal state – Followed by pallor, headache, weakness Lightheadedness and Syncope: Vasovagal Attack • Prevention – Good hydration (electrolyte/ sports drink) – Eat before insertion – Isometric muscle tensing during procedure • “Grip your hands together, then pull hard” • “Squeeze your leg muscles as hard as you can” • Management – Continue isometric muscle tensing – Elevate patient’s legs while remaining supine – If HR remains <60 bpm or convulsive syncope, give atropine 0.4 mg IV push Grubb BP N Engl J Med 2005 Lightheadedness and Syncope: Other Causes • Hyperventilation – Due to low CO2 levels (respiratory alkalosis) – Heart rate normal or tachycardia – Treat with shallow breaths or re-breathing bag • Local anesthetic toxicity (if cervical block) – CNS: lightheadedness, restlessness, anxiety, tinnitus, tremor, twitch, perioral numbness, visual changes, seizure, respiratory arrest – CV: bradycardia, arrythmia, hypotension 72 Bleeding from Tenaculum Site • Remove tenaculum slowly • Apply pressure for at least 60 seconds • Chemical cautery − Silver nitrate − Monsel’s solution • Suturing very rarely is necessary 73 IUC Complications Absolute risk Comment Perforation 1/1,000 Mostly benign Expulsion 1-6/100 Most are self-recognized Unsuccessful placement 9/ 100 6% when different device is used after unsuccessful attempt Pregnancy <1/HWY Minimal impact if removed early in pregnancy PID 1-2/TWY Same as gen’l population Sivin I, Stern J.Fertil Steril 1994 HWY: per 100 women per year TWY: per 1,000 women per year IUC Complications Absolute risk Comment Perforation 1/1,000 Mostly benign Expulsion 1-6/100 Most are self-recognized Unsuccessful placement 9/ 100 6% when different device is used after unsuccessful attempt Pregnancy <1/HWY Minimal impact if removed early in pregnancy PID 1-2/TWY Same as gen’l population Sivin I, Stern J.Fertil Steril 1994 Signs of Possible Complications Symptom Severe bleeding or abdominal cramping 3–5 days after insertion Possible Explanation Perforation, infection Irregular bleeding and/or Dislocation or perforation pain every cycle Fever, chills, unusual vaginal discharge Infection more… Signs of Possible Complications Symptom Pain during intercourse Possible Explanation Infection, perforation, partial expulsion Missed period, other signs of pregnancy, expulsion Pregnancy (uterine or ectopic) Shorter, longer, or missing threads Partial or complete expulsion, perforation Genital Tract Infections • If cervical or vaginal infection diagnosed – IUC removal not necessary – Treat infection – Counsel re: prevention of STI transmission • If PID diagnosed – IUC removal usually not necessary – Treat infection – Recommendations to remove IUC are not evidence-based – Consider removal if no improvement 48-72 hours after starting treatment Penney G. J Fam Plann Reprod Health Care. 2004 WHO. Selected Practice Recommendations for Contraceptive Use. 2004 78 Actinomyces-Like Organisms (ALO) • Actinomyces israelii has characteristics of both bacteria and fungus; part of GI flora • May asymptomatically colonize the frame of the IUC, which in itself is not dangerous • Very small percentage of women with IUC + actinomyces will develop pelvic actinomycosis – Presentation is similar to severe PID • Women with ALO on Pap smear – Should be examined to exclude PID – If none, don’t treat actinomyces or remove IUC 79 Uterine Perforation • More likely to occur in relation to – Posterior uterine position – Extreme flexion – Skill/experience of provider – Insertion 2 days-4 weeks after childbirth • Typical location is midline at uterine fundus…if so, perforation often is asymptomatic, benign • Suspect if sounding is much deeper than expected Grimes, et al. Cochrane Library, 2001, Issue 2. Markovitch O, et al. Contraception 2002 Caliskan E, et al. The European Journal of Contraception and Reproductive Health Care 2003 80 Harrison-Woolrych M, et al. Contraception 2003; Management of Uterine Perforation • • • • • If before insertion of IUC, stop procedure If during insertion of IUC, remove IUC Monitor for 30 min for excessive bleeding, pain Provide alternative method of contraception Can insert another device after next menses 81 Prevention of Uterine Perforation • Why sound the uterus at all? – Determine the “pathway” to the fundus – Preliminary dilation of the internal os – Establish depth to fundus to set flange – Ensure depth within 6-10 cm limits • Bend sound to mimic uterine flexion • Brace fingertips on speculum to achieve control of force while advancing the sound • EMB device can be used instead of metal sound • Open IUC package after sounding completed 82 IUC Expulsion • Occurs in 1-10% IUC insertions within first year • Risk of expulsion related to – Provider’s skill at fundal placement – Age, parity, BMI,uterine configuration – Time since insertion (↑ within first 6 mos) – Timing of insertion (menses, postpartum, postabortion) • Asymptomatic expulsion often presents with an (unanticipated) pregnancy • Partial expulsion may present with – Pelvic pain, cramps, intermenstrual bleeding – Pregnancy P Bednarek, et al N Engl J Med 2011; 364:2208-2217 M Cremer, et al Contraception 2011; 83:522-527 83 Missing IUC String: Diagnosis • Possibilities… – Expulsion, pregnancy, embedment, translocation • Initial management – Probe for strings in cervical canal Cytology brush to tease from canal Endocervical speculum or forceps – Rule out pregnancy – Prescribe back-up contraceptive method until intrauterine location is confirmed Prabhakaran S. et, al. Contraception.2011 84 Missing IUC String: Management •No IUC string in canal •Pregnancy test negative Desires retention Desires removal + initial UTZ Attempt extraction In Situ Extracted Embedded Op hysteroscopy Extracted OR UTZ Absent KUB Absent Present KUB Not felt Present Translocated UTZ Absent Expelled In Situ Absent Translocated 85 Missing IUC String: Treatment • In situ (intrauterine) placement: desires continuation – Leave in place for remainder of IUC lifespan • In situ placement: desires removal – Use straight or “alligator” forcep, + simultaneous real time pelvic ultrasound – Crochet hook best for circular IUCs; less helpful with T-shaped IUCs – If unsuccessful, extract via operative hysteroscopy • Translocation (IUC in peritoneal cavity) – Extract via operative laparoscopy 86 Pregnancy With IUC In Situ • Determine site of pregnancy (IUP or ectopic) • If intrauterine pregnancy confirmed – Termination planned: await procedure – Continue pregnancy: remove IUC if strings visible – Removal decreases risk of spontaneous abortion, premature delivery • Retention of IUC (if strings not visible) – Increase surveillance for SAB, pre-term birth – No greater risk of birth defects (extra-amniotic) 87 Family PACT IUC Policy: Purchase and Records • IUCs must be FDA-approved devices, labeled for US use, and obtained from FDA approved distributors • Providers must record the lot number in the med record and keep a written or electronic log of all IUCs inserted for at least 3 years from insertion • Maintain invoices > 3 years from date of invoice • Patients must be provided with a record of the dates of insertion and expiration 88 Billing Instructions for IUCs Primary Diagnosis Codes • S401: Evaluation prior to initiation of the method, whether or not the IUC is inserted that day – Use S401 when performing the insertion of the first IUC for this client • S402: Maintain adherence and surveillance for a current user of an IUC, whether or not the client is new to the provider – Use S402 when replacing an IUC with another of the same type or a different type – Both insertion and removal may be billed on the same date of service 89 Billing Instructions for IUCs Insertion or Removal Procedures • Insertion – CPT 58300: Insertion of IUC – 58300-ZM: Insertion supplies – Kit: X1522 (ParaGard) or X1532 (Mirena) – E&C: contraceptive counseling visit • Removal – CPT 58301: Removal of IUC – 58301-ZM: Removal supplies – E&C: contraceptive counseling visit 90 IUC Complication Coverage • New Family PACT benefits for IUCs – CPT-4 code 76857: Ultrasound, pelvic (nonobstetric) – CPT-4 code 76830: Ultrasound, transvaginal – Billing requirements for code 74000 are revised • 3 codes billed in conjunction with primary diagnosis code S402 and secondary diagnosis code V45.51 (intrauterine contraceptive device). A Treatment Authorization Request is not required. • S4032 will no longer be a valid Family PACT PDC effective for dates of service on or after June 1, 2011. 91 IUC Complication Coverage • IUC complications – S403 Vaso-vagal episode – S4031 Pelvic infection (secondary to IUC) – S4032 “Missing” IUC- no longer a valid code – S4033 Perforated or translocated IUC • Covered complication services include – Hysteroscopy, dilation and curettage – Laparoscopy/ laparotomy • All complication services must be approved by TAR • Please consult PPBI @ familypact.org 92 IUC Insertion Practicum • Insertion of LNG-IUC • Insertion of Cu-T IUC • The “Difficult” IUC Insertion 93 Steps for IUC Insertion • • • • • • Perform bimanual pelvic exam to determine anterior or retro- flexion Inspect cervix for mucopus Cleanse cervix with antiseptic Use of sterile gloves vs. “no-touch” technique Apply tenaculum – Routine vs. selective local anesthetic injection – Hold hand in palm-up position – “Squeeze” closed; don’t “snap” ratchet – Horizontal or vertical application (purchase) Routine vs. selective use of cervical block 94 Steps for IUC Insertion • Sound the uterus – Purposes Determine the “pathway” to the fundus Preliminary dilation of the internal os Establish depth to fundus to set flange Ensure depth within 6-9 cm limits – Bend sound to mimic uterine flexion – Brace fingertips on speculum to achieve control of force while advancing the sound – EMS* device can be used instead of metal sound EMS*: endometrial sampling 95 Mirena: The Inserter “Never let go of the Slider!!” 96 Steps for Mirena Insertion* 1. Open sterile package 2. Release the threads 3. Make sure the slider is ….in the furthest position ….away from you 4. Check that the arms of the IUC are horizontal * Excerpted from package insert 97 Steps for Mirena Insertion* 5. Pull on both threads to draw IUC system into insertion tube 6. Both knobs at ends of IUC arms are now within the inserter 98 Steps for Mirena Insertion* 7. Fix threads tightly into the cleft at near end of inserter shaft 99 Steps for Mirena Insertion* 8. Set upper edge of movable green flange to the depth of uterine sound 100 Steps for Mirena Insertion* 9. Hold slider with forefinger, or thumb, firmly in furthermost position 10. Move inserter thru cervical canal until flange is about 1.5- 2.0 cm from cervix - allows sufficient space for IUC arms to open 101 11. While holding inserter steady, release arms of IUC by pulling slider back until it reaches the raised mark on inserter 102 Steps for Mirena Insertion* 12. Push inserter gently until flange touches cervix. The IUC should be in fundal position 103 Steps for Mirena Insertion* 13. Pull down on slider all the way; threads will uncleat automatically and release IUC system Double check that the strings are uncleated before withdrawing the inserter 104 Steps for Mirena Insertion* 14. Remove inserter and cut threads about 2 to 3 cm from cervix 15. Measure and record in patient’s chart 16. Have patient feel for IUC threads 105 ParaGard Insertion* • Load arms into inserter * Excerpted from package insert 106 ParaGard Insertion • Load arms into inserter 107 ParaGard Insertion • Advance insertion tube to fundus • Fundal resistance should be coincident with the marker reaching the exocervix 108 ParaGard Insertion • Pull back on inserter tube while holding white rod steady to deposit IUC in cavity 109 ParaGard Insertion • Push inserter tube until resistance to seat the arms of the IUC in the fundus 110 ParaGard Insertion • Withdraw the white rod while holding inserter tube steady 111 ParaGard Insertion • Slowly withdraw the inserter from the cervical canal • Trim threads to 3-4 cm. Optional • Repeat bimanual exam or perform ultrasound to check placement 112 IUC Insertion: Tricks of the Trade A Clinical Update on Intrauterine Contraception@arhp.org • For pain management – Oral NSAID • Naproxen sodium 440-550mg • Ibuprofen 600-800mg – Instill lidocaine in uterine cavity with an endometrial sampler – The sampler can be used instead of sound to measure depth of uterus more… 113 IUC Insertion: Tricks of the Trade A Clinical Update on Intrauterine Contraception @arhp.org • To visualize cervix – Use large speculum – If vaginal walls obscure cervix, cut off end of condom or finger of a glove and slip over metal speculum – Get better light • For women with narrow cervical canal – Misoprostol 400 mcg SL 1+ hours before insertion 114 • Reduce expulsion rate by waiting for strings to be released from cleft before withdrawal OBG Management | Vol. 21 No. 2 | February 115 What Should I Do if the LNG-IUC Isn’t at the Fundus? • There can be significant migration of the LNGIUC within the uterine cavity • Fundal placement insures that the tail strings will be long enough to remove the device • A device that settles within the lower uterine segment is still effective • Removal of the device is necessary only if – A portion of it protrudes from the cervix, or – There is excessive cramping with a low-lying IUC OBG Management | Vol. 21 No. 2 | February 116 What Should I Do if the Cu 380A Isn’t at the Fundus? • Fundal placement is necessary for optimal efficacy • A copper IUC in the lower uterine segment is less effective • Removal of the device and re-insertion of a new device at the fundus is necessary to insure efficacy • Do not “push” a partially expelled or low lying device up to the fundus 117 Intervention Steps in the “Difficult IUC Insertion” • Use greater outward traction on the tenaculum to minimize canal-to-endometrial cavity angulation • Place paracervical or intracervical block to relax cervical smooth muscle and reduce pain • Use os finder device, if available • Dilate internal os with metal dilators to #13F (4.1 mm) • If unsuccessful, return at a later date with use of misoprostol cervical priming 118 Os Finder Device Cervical Os Finders (Disposable Box/25) $ 49.00 Cervical Os Finder Set (Reusable Set of 3) $ 69.00 Pratt Dilators 119 Paracervical Block • Target is uterosacral ligaments • Inject at reflection of cervico-vaginal epithelium • 2 (5, 7 o’cl) or 4 sites (4,5,7,8 o’cl) submucosally to depth of 5 mm • Use spinal needle or 25g, 1 ½” needle + extender • Moore-Graves speculum allows for more movement • Tips – Start with ½-1 cc. at tenaculum site – Disguise pain of needle insertion with cough – WAIT 1-2 minutes for set up before procedure 120 Paracervical Block X 7 o’clock X X 5 o’clock 121 Paracervical Block X XX 7 o’clock X 5 o’clock X 6 o’clock 122 Intra-cervical Block • Targets the paracervical nerve plexus • 1 ½ inch 25g needle with 12 cc “finger lock” syringe • Inject ½- 1 cc. local anesthetic at 12 o’clock, then apply tenaculum • Angulate needle at the hub to 45o lateral direction • At 3 or 9, insert needle into cervix to the hub 1 cm lateral to external os, aspirate • Inject 4 cc of local, then last 1 cc while withdrawing • Rotate barrel 180o, then inject opposite side 123 Intracervical Block X 9 o’clock X X 3 o’clock 5 o’clock 7 o’clock 6 o’clock 124 Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women • Nulliparous women 400 mcg of buccal misoprostol or placebo 90 min prior to IUD insertion. • No significant differences in patient-reported pain with IUD placement (misoprostol 65 mm , placebo 55 mm) at any other time point. • The misoprostol group reported significantly more preinsertion nausea (29% vs. 5%) and cramping (47% vs. 16%) than the placebo group. • While provider-reported ease of insertion was not significantly different between groups, three placebo patients required additional dilation vs. none in the misoprostol group. • All 35 subjects underwent follow-up at least 1 month postinsertion, and no expulsions were reported. CONCLUSION: • Prophylactic misoprostol prior to IUD placement in nulliparous women did not reduce patient perceived pain, but it did appear to increase preinsertion side effects. Edelman AB, et al. Contraception. 2011 • 80 nulliparas treated 1 hour prior to IUD insertion – Misoprostol 400 mcg SL and diclofenac 100 mg – Diclofenac 100 mg PO alone (control group) • Findings – Insertion considered easier by the provider with misoprostol than control group – Pt pain scores no different in the two groups – Most side effects equal • Shivering, diarrhea more common in misoprostol group Saav I et. al., Human Reproduction 2007; 22, (10): 2647 126 Misoprostol for IUC Insertion • Conclusion – Misoprostol facilitates IUD insertion and reduces the number of difficult and failed attempts of insertions in women with a narrow cervical canal 127 Saav I et. al., Human Reproduction 2007; 22, (10): 2647 Prophylactic misoprostol prior to IUD insertion in nulliparous women • RCT, nulliparous women, 18–45 years old – MPL 400 mcg bucally or placebo 90 min prior – 36 women completed the study • Findings – MPL group a trend toward a more painful insertion – Ease of placement was no different between groups – MPL group had more pre-insertion nausea and cramping than the placebo group (50% vs. 16%) – No reported expulsions Shaefer E et al, Contraception 2010 Misoprostol for IUC Placement Take It Home • Misoprostol works well to soften and dilate the cervix in pregnant women • Studies in non pregnant women having GYN procedures (hysteroscopy, EMB ) have mixed results • MPL prior to IUC placement is often recommended But • Little evidence to support a clear benefit of this practice • Some evidence that it may be harmful • It should not be accepted as a “standard practice” yet Ms D: “I Have Fibroids” • Ms D is a 35 year old G0 P0 woman who is seen for contraceptive counseling • Over the past 2 years, her periods have been heavier and longer than previously • Bimanual exam: Irregular 12 week size uterus • LNG-IUS chosen for contraception and bleeding control • Clinical dilemmas… – LNG-IUS control of fibroid-related bleeding – Technical IUC insertion issues with uterine fibroids 131 LNG-IUS and Fibroids • Small studies with mixed results – Mercorio (2003): 75% persistent menorrhagia – Starczewski (2000): 92% reduced bleeding • Recommendations – Off-label use; may violate precaution regarding cavity depth and distortion of uterine cavity – Reasonable to attempt treatment with Mirena – Documentation of informed consent content a must 132 Tips for IUC Insertion in Women with Fibroids • Determine fibroid location by ultrasound – Fundal fibroids (intramural, sub-serous) that do not distort uterine cavity do not preclude IUC use – Large sub-mucous fibroids, especially in lower uterine segment, contraindicate IUC use – Evaluate for other pathology, e.g., polyp • Ultrasound guidance may facilitate safe placement • No data on efficacy, but probably not compromised with LNG-IUS or with Cu-T if fundal placement 133