Misoprostol for Second Trimester Termination of Pregnancy (MIMIS)
To compare the efficacy of two different dose regimens of misoprostol administered vaginally in combination with mifepristone in second trimester termination of (non)viable pregnancy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Mifepristone (RU 486) and Misoprostol for Second Trimester Termination of Pregnancy. A Comparison of Two Different Dose Regimens.|
- Expulsion rate and the number of incomplete abortions warranting surgical evacuation of retained products of conception. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- time between the first administration of misoprostol to to delivery of the foetus [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
|Study Start Date:||October 2000|
|Study Completion Date:||March 2005|
|Primary Completion Date:||September 2004 (Final data collection date for primary outcome measure)|
|Active Comparator: A||
mifepristone 200 mg followed by 200 µg misoprostol per vaginam 36- 48 hours later at 4 hourly intervals (with a maximum of 10 administrations in 48 hours) until the foetus was delivered.
|Active Comparator: B||
mifepristone 200 mg followed by 400 µg misoprostol per vaginam 36- 48 hours later at 4 hourly intervals (with a maximum of 10 administrations in 48 hours) until the foetus was delivered.
The study was designed as a prospective double blinded randomised controlled trial, comparing 200µg to 400 µg misoprostol given vaginally at four hour intervals, starting 36-48 hours after the oral administration of mifepristone 200 mg at a gestational age between 14 to 24 weeks.