Comparing Two Regimens for Medical Abortion: Mifepristone + Misoprostol Versus Misoprostol Alone-3 Hour Intervals
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 441
- Locations
- 2
- Primary Endpoint
- Number of women with a complete abortion using study drug alone without recourse to surgical intervention
Study Overview
Brief Summary
This double blinded, placebo-controlled randomized trial will compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days since last Menstrual Period (LMP) in Tunisia and Vietnam. The first regimen will include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol. The second regimen will include two 800 mcg doses of buccal misoprostol three hours apart. All drugs are administered AT home by the participant.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Gestational age < 63 days since LMP, confirmed by ultrasound or clinical assessment.
- •General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination.
- •Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up.
- •Able to consent to study participation.
Exclusion Criteria
- •Gestational age > 63 days LMP
- •Confirmed or suspected ectopic or molar pregnancy
- •Contraindications to medical abortion including intra-uterine device (IUD) in place (must be removed before procedure), chronic adrenal failure, concurrent long-term corticosteroid therapy, history of allergy to mifepristone, misoprostol or prostaglandin, hemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyries.
Arms & Interventions
mifepristone+misoprostol
200 mg mifepristone + 800 mcg buccal misoprostol
Intervention: medical abortion (Drug)
buccal misoprostol
2 doses of 800 mcg buccal misoprostol
Intervention: medical abortion (Drug)
Outcomes
Primary Outcomes
Number of women with a complete abortion using study drug alone without recourse to surgical intervention
Time Frame: one week from initial treatment
Number of participants with a complete abortion after treatment without recourse to surgical intervention as a measure of efficacy of the study regimens
Secondary Outcomes
- Number of women who indicate that the side effects of buccal misoprostol, administered either alone or in combination with mifepristone, is acceptable in Tunisia and Vietnam(one week from initial treatment)
- Evaluate whether women administering buccal misoprostol have a complete abortion with study drug and experience any adverse events, at a rate that is similar to other routes of misoprostol administration(one week from initial treatment)
- Measuring the proportion of women who report their medical abortion procedure to be acceptable in Tunisia and Vietnam(one week from initial treatment)
- Determining whether women can take both the mifepristone and misoprostol at home on their own by assessing protocol compliance(one week from initial treatment)