Medication Abortion with Misoprostol-Only: A Sample Protocol

A team of experts led by Gynuity Health Projects has published a sample protocol for medication abortion with misoprostol-only.

The protocol is accompanied by a commentary, including a summary of data, and is intended to serve as guidance for facility-based providers in the U.S. wishing to offer a misoprostol-only medication abortion through 84 days (12 weeks) of pregnancy.

The recommended misoprostol-only regimen involves taking 800 mcg of misoprostol either sublingually or vaginally, repeated every three hours for a total of three or four doses. An additional dose should be provided so that the patient can use it if needed.

Ensuring continued access to evidence-based abortion care in the U.S. is paramount. While regimens comprising both mifepristone and misoprostol have been the standard for medication abortion, misoprostol alone is recommended as a safe and effective alternative and is commonly used where mifepristone is not available or accessible.

Ongoing or continuing pregnancy with misoprostol only is more likely compared to regimens involving mifepristone. A follow-up strategy to assess abortion outcome is important.

Background Note

The sample protocol for medication abortion with misoprostol-only was developed in response to a lawsuit, Alliance of Hippocratic Medicine v. FDA, challenging the U.S. Food and Drug Administration’s initial approval of mifepristone.

A Texas federal judge is widely expected to rule in favor of the plaintiffs, a conservative coalition opposed to abortion. The ruling, expected soon, could order the FDA to reverse recent changes to FDA regulations allowing mifepristone to be dispensed by pharmacies and sent through the mail or it could force manufacturers to withdraw mifepristone from the U.S. market, severing access to the medicine even in states where abortion is protected.

Mifepristone was first approved in the U.S. by the FDA in 2000. It has an indisputable safety and efficacy profile that is supported by an overwhelming body of well-documented scientific and medical evidence, as well as real world experiences.

The authors thank the editorial team at Contraception for expeditiously reviewing, revising, and accepting the manuscript for publication.

Elizabeth G. Raymond, Alice Mark, Daniel Grossman, Anitra Beasley, Kristyn Brandi, Jen Castle, Mitchell D. Creinin, Caitlin Gerdts, Laura Gil, Melissa Grant, April Lockley, Jamila Perritt, Tara Shochet, Dominique Truan and Ushma D. Upadhyay, Medication Abortion with Misoprostol-Only: A Sample Protocol, Contraception, (2023) doi: https://doi.org/10.1016/j.contraception.2023.109998

Gynuity Health Projects has been a pioneer in this field. You can refer to the Resources section of our website for articles published in peer-reviewed journals.