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Misoprostol for Second Trimester Termination of Pregnancy (MIMIS)

This study has been completed.
Sponsor:
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT00945997
First received: July 23, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Termination of Pregnancy Second Trimester
 Drug: misoprostol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mifepristone (RU 486) and Misoprostol for Second Trimester Termination of Pregnancy. A Comparison of Two Different Dose Regimens.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Expulsion rate and the number of incomplete abortions warranting surgical evacuation of retained products of conception. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time between the first administration of misoprostol to to delivery of the foetus [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 176
Study Start Date: October 2000
Study Completion Date: March 2005
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A 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.
Other Names:
  • migegyne
  • cytotec
Active Comparator: B Drug: 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.
Other Names:
  • mifegyne
  • cytotec

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.

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945997

Locations
Netherlands
Academic Medical Center
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

No publications provided

Responsible Party: JFGM Brouns, Zaans medical center
ClinicalTrials.gov Identifier: NCT00945997     History of Changes
Other Study ID Numbers: P00.0427L
Study First Received: July 23, 2009
Last Updated: July 23, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
misoprostol
mifepristone
medical abortion
randomised controlled trial

Additional relevant MeSH terms:
Mifepristone
Misoprostol
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
 Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Nonsteroidal

ClinicalTrials.gov processed this record on May 19, 2013