A Multicenter, Randomized Comparison of Mifepristone and Misoprostol Administered Simultaneously Versus 24 Hours Apart for Abortion Through 63 Days
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 1,128
- Locations
- 4
- Primary Endpoint
- complete abortion rate
Study Overview
Brief Summary
This is a multicenter, randomized study. 564 healthy women, age 18 years or older, with an intrauterine pregnancy, and requesting a medical abortion, will be recruited to participate in this prospective clinical trial. This study will provide an evaluation of oral mifepristone 200 mg and vaginal misoprostol 800 mcg administered simultaneously in women up to 63 days gestation. The aims of the study are to compare the complete abortion rates, at 7 and 14 days after misoprostol administration, when using mifepristone 200 mg orally and misoprostol 800 mcg vaginally are administered simultaneously and 24 hours apart in women up to 63 days gestation. Assessment of side effects (nausea, vomiting, pain) as well as acceptability will be done using pre and post-study questionnaires, and visual analogue scales. Complete abortion rate within 24 hours is expected to be 90%
Detailed Description
This is a multicenter, randomized study. 564 healthy women, age 18 years or older, with an intrauterine pregnancy, and requesting a medical abortion, will be recruited to participate in this prospective clinical trial. This study will provide an evaluation of oral mifepristone 200 mg and vaginal misoprostol 800 mcg administered simultaneously in women up to 63 days gestation. The aims of the study are to compare the complete abortion rates, at 7 and 14 days after misoprostol administration, when using mifepristone 200 mg orally and misoprostol 800 mcg vaginally are administered simultaneously and 24 hours apart in women up to 63 days gestation. Assessment of side effects (nausea, vomiting, pain) as well as acceptability will be done using pre and post-study questionnaires, and visual analogue scales. Complete abortion rate within 24 hours is expected to be 90%.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •pregnancy equal to or less than 63 days at enrollment -
Exclusion Criteria
- •abnormal pregnancy diagnosed by ultrasound
Outcomes
Primary Outcomes
complete abortion rate
Time Frame: 5 weeks after treatment
Secondary Outcomes
- to compare complete abortion rates by gestational age(5 weeks after treatment)
- compare bleeding and side effect profiles(up to 5 weeks after treatment)
- compare the expression of EP3 receptor mRNA in cervical tissue 2 and 24 hours after mifepristone treatment to pretreatment control(up to 24 hours after treatment)
- compare acceptability of the two regimens(2 weeks after treatment)
- describe the prevalence of domestic violence in a medical abortion research population(at time of enrollment)
- measure time to first ovulation(up to 10 weeks after treatment)
- compare elapsed time to ovulation between treatment regimens(up to 10 weeks after treatment)
- evaluate continuation rates of combined hormonal contraceptives in women with immediate initiation versus traditional Sunday start(up to 12 weeks after treatment)