Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP): A Randomized-controlled Double-blinded Trial
Overview
- Phase
- Phase 3
- Intervention
- Mifepristone+misoprostol
- Conditions
- Abortion, Induced
- Sponsor
- Gynuity Health Projects
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Rate of successful abortion: defined as complete evacuation of uterus using study drug without recourse to any additional intervention.
- Status
- Terminated
- Last Updated
- 14 years ago
Overview
Brief Summary
The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 20 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Meet legal criteria to obtain abortion
- •Present with closed cervical os and no vaginal bleeding
- •Live fetus at time of presentation for service
- •Have no contraindications to study procedures, according to provider
- •Be able to consent to procedure, either by reading consent document or by having consent document read to her
- •Be willing to follow study procedures
Exclusion Criteria
- •Known previous transmural uterine incision
- •Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
- •Any contraindications to vaginal delivery, including placenta previa
- •Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
Arms & Interventions
Mifepristone + Misoprostol
200 mg mifepristone followed by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.
Intervention: Mifepristone+misoprostol
Misoprostol
Placebo resembling 200mcg mifepristone followed by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses
Intervention: Placebo+Misoprostol
Outcomes
Primary Outcomes
Rate of successful abortion: defined as complete evacuation of uterus using study drug without recourse to any additional intervention.
Time Frame: every 3 hours
Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus; approximately 10-24 hours.
Time Frame: 48 hours
Secondary Outcomes
- Provision of additional interventions to manage excessive blood loss.(Within 30 days of mifepristone administration.)
- Total dose of misoprostol.(Assessed at time of complete abortion with study drug alone or when total maximum dose given: approximately 10-24 hours after first dose of misoprostol administration.)
- Any heavy bleeding, uterine rupture, or infection requiring additional treatment(Within 30 days of mifepristone administration.)
- Pain experienced by the woman(Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration.)
- Women's acceptability of the assigned method(Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration.)