Skip to main content
OpenTrials
Completed

NCT Number: NCT00945997

Misoprostol for Second Trimester Termination of Pregnancy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Termination of Pregnancy Second Trimester

Age range

16 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

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.

Other names: migegyne, cytotec

Primary outcomes

  1. Expulsion rate and the number of incomplete abortions warranting surgical evacuation of retained products of conception.

    Time frame: 8 weeks

Secondary outcomes

  1. time between the first administration of misoprostol to to delivery of the foetus

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: MIMIS

Important dates

Study start
2000
Primary completion
2004
Study completion
2005
First posted
Jul 24, 2009
Registry last updated
Jul 24, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.