Termination of Pregnancy Second Trimester
Conditions
Keywords
misoprostol, mifepristone, medical abortion, randomised controlled trial
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.
Interventions
DRUGmisoprostol
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.
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expulsion rate and the number of incomplete abortions warranting surgical evacuation of retained products of conception. | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| time between the first administration of misoprostol to to delivery of the foetus | 48 hours |
Countries
Netherlands
Outcome results
None listed