The Misoprostol-Only Regimen Evidence Study

Conditions

• Abortion, Medical

Eligibility Criteria

Sex

FEMALE

Age

14 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Misoprostol-only medication abortion regimen — DRUG
  This intervention is an updated misoprostol-only regimen that involves being counseled on and receiving medications for a medication abortion using 3-4 doses of 800μg misoprostol administered sublingually every 3 hours.
• Combined regimen — DRUG
  This intervention will involve participants being counseled on and receiving medications for a medication abortion regimen of mifepristone (200mg orally) followed 24-48 hours later by misoprostol (800μg b/v) with a second dose of misoprostol (800μg b/v) taken 3 hours later only for those 64-77 days.

Study Details

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

Key Dates

Start date

Oct 10, 2025

Status verified

Oct 2025

Primary completion

Jan 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

1,900 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Combined regimen
  Participants in this arm are randomized to receive the standard of care combined mifepristone + misoprostol regimen. Specifically, for those with pregnancies \<64 days, mifepristone (200mg orally) followed 24-48 hours later by misoprostol (800μg b/v); for those 64-77 days, they will take a second dose of misoprostol (800μg b/v) taken 3 hours later.
• Experimental: Misoprostol-only
  Participants in this arm will be randomized to receive a misoprostol-only regimen. Specifically, 3-4 doses of 800μg misoprostol administered sublingually every 3 hours.

Primary Outcome Measure

Abortion completion [ Time Frame: 28-42 days after taking the pills ]

Locations (1)

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