NCT02412618

Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation

A Randomized Comparison of Same-Day Oral Mifepristone-Misoprostol to Misoprostol Only for Cervical Preparation in Second Trimester Surgical Abortion

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Induced Abortion

Interventions

Type	Name	Description
DRUG	Mifepristone	Progesterone antagonist
DRUG	Misoprostol	Prostaglandin E1
DIETARY_SUPPLEMENT	Placebo	Tasteless, odorless, sugar based pill

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2015-04-09
• Last updated: 2022-03-02
• Results posted: 2022-03-02