Not Yet RecruitingPhase 4

The Misoprostol-Only Regimen Evidence Study

United States1,900 participantsStarted 2025-10-10

Plain-language summary

The goal of this study is to evaluate the effectiveness, non-inferiority, and side-effect profile of an updated misoprostol-only regimen, as compared to the combined mifepristone-misoprostol regimen, among people seeking medication abortion (MAB) through 77 days of pregnancy in telehealth and in-person settings. The investigators aim to evaluate this in both in-clinic and telehealth medication abortion care in the United States. The main questions it aims to answer are: 1. What proportion of pregnant people using an updated misoprostol-only medication abortion regimen have a complete abortion using just the prescribed pills? 2. Is the updated misoprostol-only medication abortion regimen no more than 5% less effective (non-inferior) than the standard combined medication abortion regimen? 3. What is the pattern of beta hCG decline following use of a misoprostol-only medication abortion through 77 days of pregnancy? Participants will: * be randomized to one of two medication regimens (misoprostol-only or the combined regimen) in a 1:1 ratio based on duration of pregnancy at enrollment. - self-report outcomes via daily surveys for the first 3 days, and thereafter weekly at 7, 14, 21, 28, and 35 days. * return to the clinical site for tests as instructed The investigators hypothesize that the proportion with complete abortions in the misoprostol-only arm will be non-inferior to the proportion with complete abortions in the combined regimen arm within a 5% margin of inferiority

Who can participate

Age range14 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pregnancy of \< or = 77 days duration based on LMP or ultrasound * Positive pregnancy test (self-report or in-clinic) * Age: States without parental involvement laws : in-person patients ages 14 years and older; States with parental involvement or notification laws: 18 years or older * Willing and able to give informed consent * Willing to comply with study protocol * Willing to record requested information in the study surveys * English or Spanish speaking * Has a text message, email, or phone call capable device for survey completion * Understands and signs an Institutional Review Board (IRB) approved informed consent form prior to undergoing any study procedures or randomization Exclusion Criteria: * concurrent participation in any other interventional trial * unwilling to comply with the study protocol and survey/visit schedule * contraindication to mifepristone (chronic corticosteroid administration, adrenal disease) * contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, or known allergy to prostaglandin) * cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure) * diagnosis of porphyria * known bleeding disorder or receiving anticoagulants * pregnancy with an IUD in place * diagnosis of pregnancy of unknown location (PUL), early pregnancy failure, incomplete or inevitable abortion (absent gestational sac and/or open cervical os) * possibility of ectopic pregnancy * known or suspected pelvic inf…

What they're measuring

Abortion completion

Timeframe: 28-42 days after taking the pills

Non-inferiority of the misoprostol-only regimen

Timeframe: Completion measured 28-42 days after taking the pills

Trial details

NCT IDNCT07174856

SponsorIbis Reproductive Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01