Mifepristone and Mid-Trimester Termination of Pregnancy - Full Text View

Sponsor:	Boston University
Information provided by:	Boston University
ClinicalTrials.gov Identifier:	NCT00382538

Purpose

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	Intervention
Abortion, Induced Abortion, Second Trimester	Drug: Addition of mifepristone 200 mg 24 hours before induction

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized, Placebo-Controlled, Double-Blinded Study of Mifepristone in Midtrimester Termination of Pregnancy

Resource links provided by NLM:

Drug Information available for: Mifepristone

U.S. FDA Resources

Further study details as provided by Boston University:

Primary Outcome Measures:

Time from start of induction to fetal delivery

Estimated Enrollment:	64
Study Start Date:	March 2005
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Ages Eligible for Study:	16 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382538

Locations

United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118

Sponsors and Collaborators

Boston University

Investigators

Principal Investigator:

Lynn Borgatta, MD, MPH

Boston University

More Information

No publications provided by Boston University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kapp N, Borgatta L, Stubblefield P, Vragovic O, Moreno N. Mifepristone in second-trimester medical abortion: a randomized controlled trial. Obstet Gynecol. 2007 Dec;110(6):1304-10.

ClinicalTrials.gov Identifier:	NCT00382538 History of Changes
Other Study ID Numbers:	24597
Study First Received:	September 28, 2006
Last Updated:	October 3, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Boston University:

mifepristone
induction
abortion
injection, intra-amniotic

Additional relevant MeSH terms:

Mifepristone
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

ClinicalTrials.gov processed this record on February 09, 2012