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Misoprostol for Second Trimester Termination of Pregnancy (MIMIS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00945997
First Posted: July 24, 2009
Last Update Posted: July 24, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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 ]

Secondary Outcome Measures:
  • time between the first administration of misoprostol to to delivery of the foetus [ Time Frame: 48 hours ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945997


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

Responsible Party: JFGM Brouns, Zaans medical center
ClinicalTrials.gov Identifier: NCT00945997     History of Changes
Other Study ID Numbers: P00.0427L
First Submitted: July 23, 2009
First Posted: July 24, 2009
Last Update Posted: July 24, 2009
Last Verified: July 2009

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

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