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Early Medical Abortion: an overview

Early Medical Abortion: an overview. Patricia A. Lohr, FACOG FRCOG FFSRH (Hons) Medical Director, British Pregnancy Advisory Service S outhern Taskgroup on Abortion and Reproductive Topics EMA Conference 6 October 2018 * Cork, Ireland. Diclosures.

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Early Medical Abortion: an overview

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  1. Early Medical Abortion: an overview Patricia A. Lohr, FACOG FRCOG FFSRH (Hons) Medical Director, British Pregnancy Advisory Service Southern Taskgroupon Abortion and Reproductive Topics EMA Conference6 October 2018 * Cork, Ireland

  2. Diclosures I am Medial Director of British Pregnancy Advisory Service, a non-profit provider of abortion services in the UK I have no commercial disclosures

  3. What is medical abortion? Pregnancy termination without primary surgical intervention and resulting from the use of abortion-inducing medication Recommended medications: mifepristone and misoprostol “Early medical abortion” ≤70 days of gestation on day of mifepristone Typically outpatient Same medications may be used for termination throughout pregnancy; different regimes and location of care

  4. Mifepristone: an antiprogestogen Progesterone Blockade Cervical Softening Rhythmic Uterine Contractions Decidual Necrosis Detachment Expulsion Abortion Effectiveness of mifepristone alone ≈ 60-80% at ≤49 days of gestation

  5. Medical abortion - clinical aspects, C. Fiala Mifepristone also enhances uterine response to prostaglandins Bygdeman & Swahn Contraception 1985

  6. Misoprostol: prostaglandin analogue Most commonly recommended for use with mifepristone Cheap Stable at room temperature Multiple routes of administration: vaginal, buccal, sublingual, (oral) Effective and efficient Generally well-tolerated

  7. Early medical abortion: the past Mifepristone: 600mg oral (office) Interval: 36-48 hours Misoprostol: 400mcg oral (with observation period) Gestation: ≤49 days of gestation Follow-up: In-person ultrasound in 2 weeks

  8. Early medical abortion: the present Mifepristone: 200mg oral (home or office) Interval: 24-48 hours Misoprostol: 800mcg vaginal, buccal or sublingual (home) Gestation: ≤70 days of gestation Follow-up: No need for routine (i.e., in person) check

  9. Chen & Creinin ObstetGynecol2015 Early medical abortion: efficacy

  10. Early medical abortion: efficiency in % 20 15 10 5 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 23 24 22 unknown Before miso (hours after misoprostol) uncertain More than 24 h later Time to expulsion of the sac in 1720 women with successful termination of pregnancy. The women took mifepristone on day 1 and misoprostol 48 hours later. Uncertain means expulsion at some point during 24 hours following misoprostol. Unknown means expulsion at some point later than 24 after misoprostol. Source: The New England Journal of Medicine, 1998; 338 (18): 1244 Medical abortion - clinical aspects, C. Fiala

  11. 57-63 days vs. 64-70 days *Number followed Abbas D et. al Contraception 2015

  12. Early medical abortion: side effects Mifepristone package insert. Approved 2016 http://www.earlyoptionpill.com/wp-content/uploads/2016/03/MIFEPREX-Labeling-and-MG-FINAL_March2016.pdf Mifepristone package insert. Approved 2016 http://www.earlyoptionpill.com/wp-content/uploads/2016/03/MIFEPREX-Labeling-and-MG-FINAL_March2016.pdf

  13. Early medical abortion: safety Retrospective review 200mg mifepristone + 800mcg buccal misoprostol ≤ 63 days 317 US sites over 2 years, N=233,805 Overall clinically significant adverse event: 1.6 per 1000 A&E treatment 1 per 1000 IV antibiotics 2 per 10,000 Transfused 5 per 10,000 Hospitalised 6 per 10,000 Undiagnosed ectopic 7 per 100,000 Mortality: 0.4/100,000 Cleland K et al ObstetGynecol2013

  14. 57-63 days vs. 64-70 days • Fewer expulsions within 3h; no difference by 24h • More vomiting, diarrhoea, fever, weakness • No difference adverse events, e.g., hospital admissions, transfusions (0.7% vs. 0.5%, p=0.31) • Work on-going to 77 days p=0.001 at 3 h Winikoff B et al ObstetGynecol2012 p=0.43 at 24 h Abbas D, et al. Contraception 2015

  15. Ectopic pregnancy: a very rare occurrence with early abortion Ectopic pregnancy in the general population: ≈1 in 100 Ectopic pregnancy in women seeking abortion US trial of surgical abortions <6 weeks’ gestation: 5.9 per 1,000 Largest single study of medical abortion (n=16,369): 1.3 per 1,000 Review of 57 prospective medical abortion trials (n=44,789) found a rate of 2 in 10,000 diagnosed after treatment Edwards J and Carson A AJOG 1997; Ulmann A et al ActaObstetGynecol Scand. 1992 ; Shannon C et al ObstetGynecol2004

  16. Early medical abortion care pathway

  17. Pre-abortion assessment Understand woman’s decision about the pregnancy Determine gestational age ≤10 weeks Assess eligibility for method and location of care Decide if anti-D prophylaxis is indicated An invitation to discuss contraception and screening for STIs also form part of pre-abortion care

  18. Do women need counselling? Most women seeking abortion Are sure of their decision before contacting a clinician Have already discussed the decision with friends/relatives (9% with a counselling service) Do not want further counselling In one study, 18% (33 of 185) wanted decision-making support from their doctor or nurse Of these, 6 chose not to have the abortion None booked with local counselling service Allen 1985; Barrett et al 2004; Lakha & Glasier 2006; Cameron & Glasier 2013, Baron et al 2015

  19. What women want: decision-making support Qualitative interviews with women seeking abortion advise that most women need/want Non-judgmental interaction with a provider An explanation of treatment options and risks Prompt treatment Decision-support tools available to assist the generalist or referral to existing counselling/crisis pregnancy centres Baron C et al J Fam PlannReprod Health Care. 2015 ;Kumar U et al J Fam PlannReprod Health Care. 2004

  20. Determining gestational age Goal: determine eligibility for early medical abortion No need to be as accurate as when dating for antenatal care Regimen effectiveness decreases graduallywith gestation Absence of evidence that routine ultrasound improves the safety of medical abortion Some evidence that most women seeking medical abortion know their LMP and that LMP (± bimanual) can accurately determine eligibility for most women Kulier and Kapp Contraception. 2011: Kaneshiro et al Contraception. 2011; Schonberg et al 2014; Raymond & Bracken 2015

  21. Indications for ultrasound Unknown LMP Adnexal mass or pain Significant size/dates discrepancy Provider uncertainty with exam History of previous ectopic pregnancy Became pregnant with IUD in place

  22. Contraindications and cautions Contraindications Chronic adrenal failure (long term systemic steroid use) Severe asthma uncontrolled by therapy Inherited porphyria Suspected extra-uterine pregnancy Haemorrhagic disorders or concurrent anticoagulant therapy Allergy to mifepristone or misoprostol If IUD in situ, remove before treatment In the absence of specific studies, mifepristone not recommended those with malnutrition, hepatic or renal failure

  23. Treatment Tailoring to women’s needs Medications (office or home use) and how to use them Advice on pain and symptom management Normal process vs. worrying signs and symptoms How to get help/advice Mel Chin "RU 486 Quilt" (1996)

  24. Misoprostol at home: safe, effective, preferred by women Systematic review: 9 prospective cohort studies Home vs. in-clinic use (n = 4,522) Odds complete abortion: 0.8 (95% CI: 0.5–1.5) Serious complications rare and not different between groups More choosing home use would choose medical again Ngo TD et al Bull WHO 2011

  25. Mifepristone at home also preferable, acceptable, feasible and safe Success and complication rates not different between home and clinic users Gold M and Chong E Contraception 2015

  26. Routine (in person) follow-up no longer recommended after medical abortion Treatment highly effective; very few need intervention With guidance, those needing intervention will present Out-of-hours helplinehelpful Multiple visits neither feasible nor desirable for women or providers Routine post-scan may increase unnecessary interventions Options Pre/post serum hCG Urine hCG with phone call or self assessment checklist Ultrasound only as needed or if preferred “I still feel pregnant” both sensitive and specific WHO Safe abortion: technical and policy guidance for health systems. 2012. Grossman D et al ObstetGynecol . 2004

  27. hCG decline after misoprostol Poicus KD et al Contraception 2017

  28. In case of… Ongoing pregnancy: surgical evacuation, repeat regimen (no data but common), repeat misoprostol only ≈ 35% effective Incomplete abortion or retained non-viable pregnancy: repeat misoprostol, surgical evacuation, or watch and wait Urgent or emergent intervention very uncommon Reeves MF et al Contraception 2008

  29. Early medical abortion care pathway

  30. Thank you for your attention. patricia.lohr@bpas.org

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