The Misoprostol-Only Regimen Evidence Study

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age14+
SponsorIbis Reproductive Health

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Misoprostol-only medication abortion regimen
  • Combined regimen

Treatment groups

1,900 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ibis Reproductive Health

Lead sponsor

University of Utah

Collaborator

Planned Parenthood Association of Utah

Collaborator