Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation
- Conditions
- Induced Abortion
- Interventions
- Registration Number
- NCT02412618
- Lead Sponsor
- Medstar Health Research Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- healthy women
- eligible for non---urgent D&E
- 14 0/7 weeks to 19 6/7 weeks gestation, confirmed by sonogram
- emergent need for D&E
- fetal demise
- intolerance
- allergy or contraindication to mifepristone or misoprostol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mifepristone Mifepristone Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once Placebo Placebo Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once Mifepristone Misoprostol Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once Placebo Misoprostol Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once
- Primary Outcome Measures
Name Time Method Initial Cervical Dilation 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 Outcome Measures
Name Time Method Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale) intraoperative 5-point Likert scale given to patients following procedure once recovered from anesthesia assessing pain, side effects including nausea, vomiting, diarrhea, cramping, and if they would choose the method again or recommend to friends.
Likert scale: Strongly agree (5), Agree (4), Neutral (3), Disagree (2), Strongly Disagree (1)