Medication abortion with misoprostol-only: A sample protocol

Introduction

Mifepristone approval by the United States (U.S.) Food and Drug Administration in 2000 revolutionized abortion care in this country. In 2020, 53% of people having facility-based abortions in the U.S. had medication abortions with mifepristone and misoprostol rather than uterine evacuation procedures. A key advantage of medication abortion is that it can be provided entirely remotely by telemedicine and mail, which has been critical for patients who face barriers to accessing in-person services. In the aftermath of the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization which eliminated federal constitutional protections for abortion, the accessibility and availability of mifepristone are under increasing threat. Medication abortion regimens that do not include mifepristone are therefore of urgent interest. The most studied such regimens use misoprostol either alone or in conjunction with methotrexate or letrozole. Although randomized trials demonstrate that misoprostol-only regimens are somewhat less effective than those that include both mifepristone and misoprostol, they cause abortion in the large majority of users. Neither methotrexate-misoprostol nor letrozole-misoprostol regimens have demonstrated advantages in effectiveness, ease of use, or time to abortion over multi-dose misoprostol-only regimens.

In settings where mifepristone is not available, and especially outside the U.S., clinicians and people who self-manage abortion have been using misoprostol-only for decades. Misoprostol-only regimens are endorsed as a medically acceptable option by the World Health Organization and other international and national professional guidelines for abortion care. However, documented experience in the U.S. has been limited. Here, we present a brief summary of data on misoprostol-only abortion and a sample protocol for U.S. clinicians who wish to offer it.