Status:
NOT_YET_RECRUITING
The Misoprostol-Only Regimen Evidence Study
Lead Sponsor:
Ibis Reproductive Health
Collaborating Sponsors:
University of Utah
Planned Parenthood Association of Utah
Conditions:
Abortion, Medical
Eligibility:
FEMALE
14+ years
Phase:
PHASE4
Brief 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, ...
Detailed Description
This is a randomized controlled trial comparing misoprostol-only (3-4 doses x 800μg misoprostol sublingually every 3 hours) (Arm 2) to the combined regimen (\<64 days: mifepristone (200mg orally) foll...
Eligibility Criteria
Inclusion
- 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
- 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 infection
- Have issues or concerns (in the judgement of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.
- Have previously participated in the study
- Be a site staff member with delegated study responsibilities or a family member of, or have a close relationship with, a site staff member with delegated study responsibilities.
Key Trial Info
Start Date :
October 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
1900 Patients enrolled
Trial Details
Trial ID
NCT07174856
Start Date
October 10 2025
End Date
March 1 2027
Last Update
October 8 2025
Active Locations (1)
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1
Planned Parenthood Association of Utah
Salt Lake City, Utah, United States, 84102