The Misoprostol-Only Regimen Evidence Study
ConditionAbortion, Medical
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Misoprostol-only medication abortion regimen
DrugThis 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
DrugThis 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.
Treatment groups
1,900 Participants
are divided into 2 treatment groupsGroup A: Combined regimenActive comparator 1 intervention
Group B: Misoprostol-onlyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Abortion completion
The primary outcome for this study is complete abortion, defined as successful expulsion of the intrauterine pregnancy without need for procedural intervention or additional doses of medication during the follow-up period as determined by negative HSPT, ultrasound, or declining serum beta hCG by clinic protocols.
Time frame
28-42 days after taking the pills2
Non-inferiority of the misoprostol-only regimen
Study investigators will evaluate and report on the non-inferiority of abortion completion following use of the misoprostol-only regimen as compared to the combined mifepristone and misoprostol regimen within a 5% margin of inferiority.
Time frame
Completion measured 28-42 days after taking the pillsSecondary outcomes
1
hCG decline
We will measure declines in serum beta hCG between baseline and 7-14 days among a subset of participants to characterize patterns following use of the misoprostol-only regimen and the combined mifepristone-misoprostol regimen.
Time frame
Change in beta hCG between 0 and 7-14 days post medication abortionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ibis Reproductive Health
Lead sponsor
University of Utah
Collaborator
Planned Parenthood Association of Utah
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: