Misoprostol for Second Trimester Termination of Pregnancy (MIMIS)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Completed

Conditions: Termination of Pregnancy Second Trimester

Treatments: Drug: misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT00945997

P00.0427L

Details and patient eligibility

About

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.

Full 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.

Enrollment: 176 patients

Sex: Female

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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176 participants in 2 patient groups

A

Active Comparator group

Treatment:

Drug: misoprostol

Drug: misoprostol

B

Active Comparator group

Treatment:

Drug: misoprostol

Drug: misoprostol