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Mifepristone and Mid-Trimester Termination of Pregnancy

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ClinicalTrials.gov Identifier: NCT00382538
Recruitment Status : Completed
First Posted : September 29, 2006
Last Update Posted : October 7, 2008
Information provided by:
Boston University

Brief Summary:
Mid-second trimester medical terminations of pregnancy require admission to the hospital for the length of time it takes a woman to abort. The current protocol at BMC uses intra-amniotic digoxin injection the day prior to admission. The following day, the woman is admitted and given sequential doses of misoprostol until delivery occurs. The average length of time between the first dose of misoprostol and delivery is 12 hours, requiring most women to stay overnight. This is a randomized, placebo-controlled, double-blinded study designed to determine whether adding mifepristone significantly reduces the induction interval time (time between starting the first misoprostol and delivery) required for a second trimester termination.

Condition or disease Intervention/treatment
Abortion, Induced Abortion, Second Trimester Drug: Addition of mifepristone 200 mg 24 hours before induction

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blinded Study of Mifepristone in Midtrimester Termination of Pregnancy
Study Start Date : March 2005
Primary Completion Date : November 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Time from start of induction to fetal delivery

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 16 years of age or over
  • able to give informed consent in English or Spanish
  • Requesting termination of pregnancy

Exclusion Criteria:

  • Under 16 years of age
  • rupture membranes or intrauterine death

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): NCT00382538

United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Principal Investigator: Lynn Borgatta, MD, MPH Boston University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00382538     History of Changes
Other Study ID Numbers: 24597
First Posted: September 29, 2006    Key Record Dates
Last Update Posted: October 7, 2008
Last Verified: October 2008

Keywords provided by Boston University:
injection, intra-amniotic

Additional relevant MeSH terms:
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
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