Misoprostol for Second Trimester Termination of Pregnancy

Termination of Pregnancy Second Trimester Clinical Trial

— MIMIS  

Official title:

Mifepristone (RU 486) and Misoprostol for Second Trimester Termination of Pregnancy. A Comparison of Two Different Dose Regimens.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00945997
• Other study ID #: P00.0427L
• Status: Completed
• Phase: N/A
• First received: July 23, 2009
• Last updated: July 23, 2009
• Start date: October 2000
• Est. completion date: March 2005

Study information

• Verified date: July 2009
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: March 2005
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Termination of Pregnancy Second Trimester

Intervention

Drug:
• misoprostol
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.
• misoprostol
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.

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expulsion rate and the number of incomplete abortions warranting surgical evacuation of retained products of conception.		8 weeks	No
Secondary	time between the first administration of misoprostol to to delivery of the foetus		48 hours	No