A Randomized Comparison of Same-Day Oral Mifepristone-Misoprostol to Misoprostol Only for Cervical Preparation in Second Trimester Surgical Abortion
Overview
- Phase
- Phase 4
- Intervention
- Mifepristone
- Conditions
- Induced Abortion
- Sponsor
- Medstar Health Research Institute
- Enrollment
- 100
- Primary Endpoint
- Initial Cervical Dilation
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
A randomized double---blinded comparison of same---day mifepristone and misoprostol with misoprostol only for cervical preparation in second---trimester surgical abortion in 100 women at 14 0/7---19 6/7 weeks gestation.
Detailed Description
Women desiring abortion at gestational ages between 14 weeks 0 days and 19 weeks 6 days were randomized to 200-mg mifepristone or identical placebo with 400-mcg misoprostol vaginally 4-6 hours prior to D\&E. Primary outcome was cervical dilation assessed by the largest Hegar dilator accepted without resistance. Secondary outcomes included total procedure time, and patient and provider perceptions. The study was powered to detect a 2-mm difference in cervical dilatation with 48 participants in each arm.
Investigators
Eligibility Criteria
Inclusion Criteria
- •healthy women
- •eligible for non---urgent D\&E
- •14 0/7 weeks to 19 6/7 weeks gestation, confirmed by sonogram
Exclusion Criteria
- •emergent need for D\&E
- •fetal demise
- •intolerance
- •allergy or contraindication to mifepristone or misoprostol
Arms & Interventions
Mifepristone
Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once
Intervention: Mifepristone
Mifepristone
Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once
Intervention: Misoprostol
Placebo
Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once
Intervention: Misoprostol
Placebo
Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once
Intervention: Placebo
Outcomes
Primary Outcomes
Initial Cervical Dilation
Time Frame: Assessed 4-6 hour following medications at time of D&E procedure
Initial cervical dilation as measured by Hegar Dilator accepted with least resistance
Secondary Outcomes
- Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale)(intraoperative)