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Insights: Expanding Access to Medication Abortion: A Sample Protocol for 11.1-12.0 Weeks Estimated Gestational Duration

Written by Robin Wallace MD MAS, Rosa Topp MSN, RN

Medication abortion is now more common than procedural abortion in the United States , and a critical access point for many abortion seekers via both in-person and telehealth care since Dobbs. Common practice is to offer medication abortion through 11.0 weeks estimated gestational duration (EGD), with a combined regimen of mifepristone and misoprostol. Expanding EGD limits for medication abortion to 12.0 weeks EGD aligns with the World Health Organization guidelines, protocols for self-managed and misoprostol-only abortion endorsed by the Society of Family Planning, and is a promising path towards increasing abortion access in the U.S.

In May 2024, Planned Parenthood Federation of America (PPFA) began offering to member affiliates a protocol for optional implementation for medication abortion 11.1-12.0 weeks EGD. Guidelines for pre-abortion evaluation are unchanged from current standards, which allow for medication abortion without pretreatment ultrasound to eligible patients.1 PPFA guidelines also allow providers to forgo Rh typing and Rho(D) immune globulin administration through 12.0 weeks EGD.*

Combined regimen (preferred)
Day 1: Mifepristone 200 mg orally
Day 2 or 3: Misoprostol 800 mcg buccally every 4 hours for at least 2 doses. A third dose should be provided and taken 3-4 hours after the second dose if no tissue expulsion after two doses.

Misoprostol-only regimen (alternate)
Misoprostol 800 mcg buccally every 3 hours for at least 3 or 4 doses. A fifth dose may be provided and advised if no tissue expulsion after four doses.

While prior research on efficacy and safety includes a wide range of regimens and completion endpoints, we can extrapolate from the existing data that medication abortion at 11-12 weeks EGD will be 90-95% effective when two or more doses of misoprostol are used after mifepristone.2-5 Uterine aspiration may be required for up to 5-10% of patients and the ongoing pregnancy rate is approximately 2.5%.3 In previous studies, tissue expulsion occurred within 5 hours and after an average of 2.3 misoprostol doses.2-3 medication abortion through 12.0 weeks gestation is acceptable to patients and safe, with a serious complication rate of <1%.5-6

Patient counseling should include a discussion on expected efficacy, when to take additional misoprostol doses, and the need for aspiration if the abortion is not complete. Compared to medication abortion earlier in the first trimester, people with an EGD from 11-12 weeks are likely to have heavier bleeding, increased pain, and prolonged misoprostol side effects from multiple doses. Counseling should also address the possibility of visualizing recognizable pregnancy tissue such as a small fetus, umbilical cord and placenta.

Expanding access to safe, evidence-based abortion care through incremental increases in gestational limits for medication abortion is patient-centered and appropriate for the primary care and outpatient setting.


*Clinical guidelines from the World Health Organization, Society of Family Planning, and the National Abortion Federation recommend foregoing Rh testing and Rho(D) immune globulin administration at less than 12 weeks of gestation. RhD testing and treatment may be considered at the patient’s request as part of a shared decision-making process.


RHAP Resources:

How To Use Abortion Pills Fact Sheet

How To Use Misoprostol-Only for a Medication Abortion

Protocol for Medication Abortion Using Mifepristone and Misoprostol

Medication Abortion FAQs


Partner Resources:

World Health Organization: Clinical practice handbook for quality abortion care

Society of Family Planning Interim Clinical Recommendations: Self-managed abortion

Society of Family Planning: Medication abortion with misoprostol-only: A sample protocol

Society of Family Planning Clinical Recommendation: Medication abortion between 14 0/7 and 27 6/7 weeks of gestation


Sources:

1. Simons HR, Diemert S, Passman R, Dean G. An assessment of clinical outcomes of medication abortion without pretreatment ultrasonography in Planned Parenthood, United States, 2020-2021. Contraception. Published online April 17, 2024. doi:10.1016/j.contraception.2024.110469

2. Ashok PW, Kidd A, Flett GM, Fitzmaurice A, Graham W, Templeton A. A randomized comparison of medical abortion and surgical vacuum aspiration at 10-13 weeks gestation. Hum Reprod. 2002;17(1):92-98. doi:10.1093/humrep/17.1.92

3. Hamoda H, Ashok PW, Flett GM, Templeton A. Medical abortion at 9-13 weeks’ gestation: a review of 1076 consecutive cases. Contraception. 2005;71(5):327-332. doi:10.1016/j.contraception.2004.10.015

4. Hamoda H, Ashok PW, Flett GM, Templeton A. A randomised controlled trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion up to 13 weeks of gestation. BJOG. 2005;112(8):1102-1108. doi:10.1111/j.1471-0528.2005.00638.x

5. Løkeland M, Iversen OE, Dahle GS, Nappen MH, Ertzeid L, Bjørge L. Medical abortion at 63 to 90 days of gestation. Obstet Gynecol. 2010;115(5):962-968. doi:10.1097/AOG.0b013e3181da0c3e

6. Moseson, Heidi PhD, MPH; Jayaweera, Ruvani PhD, MPH; Egwuatu, Ijeoma BS; Grosso, Bélen BA; Kristianingrum, Ika Ayu MA; Nmezi, Sybil MA; Zurbriggen, Ruth MEd; Bercu, Chiara MPA; Motana, Relebohile PDM; Gerdts, Caitlin PhD, MHS. Effectiveness of Self-Managed Medication Abortion Between 9 and 16 Weeks of Gestation (2023) Obstetrics & Gynecology 142(2):p 330-338, August 2023.


Pharma-free: The Reproductive Health Access Project does not accept funding from pharmaceutical companies. We do not promote specific brands of medication or products. The information in the Insights is unbiased, based on science alone.


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