The MORE Study—led by Ibis researchers and Lori M. Gawron, MD, MPH, FACOG at the University of Utah—is a randomized clinical trial in the United States that aims to compare abortion completion and side-effects between an updated single drug regimen (3-4 doses of 800ug misoprostol every three hours) for medication abortion as compared to the standard combined regimen (mifepristone followed by misoprostol). Within a constrained United States healthcare and political context, The MORE Study aims to collect rigorous evidence that providers need to confidently prescribe and counsel patients on all of their medication abortion options.
The history of misoprostol-only regimens
Two safe and effective medication abortion regimens are recommended by the World Health Organization (WHO): misoprostol-only, and misoprostol in combination with mifepristone (“the combined regimen”). Early clinical trial data suggested that some misoprostol-only regimens were less effective (~85%) than the combined regimen (~95% effective), and thus pharmaceutical companies, regulators, and providers around the globe began to recommend the combined regimen as “preferred.” A recent Ibis-led analysis of existing evidence on the currently recommended regimen for misoprostol-only, however, suggests that real-world effectiveness may be higher than previously thought. Several study design and service delivery features could explain the lower effectiveness found in early misoprostol-only trials; as compared to newer data, some from self-managed settings, clinical studies have historically been predisposed to offering early procedural intervention, have used shorter timelines to evaluate completion, did not allow for additional doses of misoprostol, and have not provided comprehensive counseling on the expected experience of misoprostol-only, among other reasons. The MORE Study will, for the first time, measure experiences and outcomes following the misoprostol-only and combined regimen in the same study, allowing for greater clarity and nuance in understanding what to expect from each.
Current context
Abortion access in the United States has shifted dramatically since the Dobbs v. Jackson Women’s Health Organization decision in June 2022 overturned Roe v. Wade, and a barrage of legal and regulatory attacks on mifepristone has motivated providers and advocates around the country to prepare for the potential of significant restrictions on access to mifepristone, including the inability to send mifepristone through the mail, and/or in the worst-case scenario, removal of mifepristone from shelves altogether, even in states where abortion rights are protected. These threat to mifepristone access have sharpened the focus on the need for alternative regimens and strategies to protect and expand access to abortion. One readily available intervention is expanding the use and availability of the misoprostol-only regimen for medication abortion which presents important opportunities to expand access to care.
Join us
We are currently hiring for a full-time project director for The MORE Study. Read the job description and find application instructions here. For general questions or requests, contact the study team at morestudy@ibisreproductivehealth.org.