Misoprostol for Second Trimester Termination of Pregnancy
Not Applicable
Completed
- Conditions
- Termination of Pregnancy Second Trimester
- Interventions
- Registration Number
- NCT00945997
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 176
Inclusion Criteria
- Women with a gestational age between 14 to 24 weeks, confirmed by ultrasound, requesting termination of pregnancy
Exclusion Criteria
- No informed consent
- Mifepristone allergy
- Chronic adrenal gland failure
- Kidney failure
- Liver failure
- Chronic use of corticosteroids
- COPD not responsive to treatment
- Cardiovascular disease
- Glaucoma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B misoprostol - A misoprostol -
- Primary Outcome Measures
Name Time Method Expulsion rate and the number of incomplete abortions warranting surgical evacuation of retained products of conception. 8 weeks
- Secondary Outcome Measures
Name Time Method time between the first administration of misoprostol to to delivery of the foetus 48 hours
Trial Locations
- Locations (1)
Academic Medical Center
🇳🇱Amsterdam, Netherlands