Second Trimester Labor Induction - Full Text View

Sponsors and Collaborators:	Johns Hopkins University University of Maryland
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00592215

Purpose

A superior second trimester medical abortion regimen has not been identified. Studies suggest that a regimen of mifepristone and misoprostol given 36 to 48 hours apart has the shortest median induction-to-abortion interval, highest 24-hour abortion rate, and low rates of adverse events. Narrowing the interval between the two medications without clinically reducing effectiveness may increase access and acceptability for patients and reduce costs. Data from studies on first trimester abortions suggest that the 6 to 8 hour interval between mifepristone and misoprostol is as efficacious as the 36 to 48 hour interval. There are no studies on shorter intervals with same day administration between mifepristone and misoprostol in second trimester abortions.

The primary objective is to assess the efficacy of the combined mifepristone/misoprostol regimen for abortions between 17 0/7 and 23 6/7 weeks' gestation using an interval of 6 to 8 hours between the two medications.

Condition	Intervention	Phase
Second Trimester Labor Induction	Drug: Experimental (mifepristone and misoprostol)	Phase I

Drug Information available for: Mifepristone Misoprostol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	A Pilot Study of Mifepristone Followed by Misoprostol in Women Undergoing Second Trimester Abortion

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Abortion rate [ Time Frame: 8 hours after misoprostol administration ] [ Designated as safety issue: No ]

Estimated Enrollment:	114
Study Start Date:	March 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Mifepristone followed by labor induction with misoprostol after 6-8 hours	Drug: Experimental (mifepristone and misoprostol) Mifepristone 200mg followed by labor induction with misoprostol after 6-8 hours

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

English-speaking women
18 years of age and above
Voluntarily choose to undergo pregnancy termination via labor induction
An ultrasound-confirmed singleton intrauterine pregnancy between 17 0/7 and 23 6/7 weeks' gestation
Able to provide written consent

Exclusion Criteria:

Premature rupture of membranes
Preterm labor
Intrauterine fetal demise
Chronic systemic corticosteroid use or adrenal disease
Hypersensitivity to prostaglandins
Cardiovascular disease such as angina, valvular disease, arrhythmia, cardiac failure
Known coagulopathy or treatment with anticoagulants
Prior caesarean delivery or myomectomy
Placenta previa.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592215

Locations

United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201

Sponsors and Collaborators

Johns Hopkins University

University of Maryland

Investigators

Principal Investigator:

Rameet Singh, MD, MPH

Johns Hopkins University

More Information

Responsible Party:	Johns Hopkins University ( Rameet Singh, MD, MPH )
Study ID Numbers:	NA_00010268, 2007-663
Study First Received:	December 31, 2007
Last Updated:	August 28, 2008
ClinicalTrials.gov Identifier:	NCT00592215
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

Second trimester labor induction

Study placed in the following topic categories:

Misoprostol
Mifepristone

Additional relevant MeSH terms:

Abortifacient Agents, Steroidal
Contraceptives, Postcoital, Synthetic
Oxytocics
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Gastrointestinal Agents
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists

Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Contraceptives, Postcoital
Luteolytic Agents
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Abortifacient Agents
Menstruation-Inducing Agents
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on January 16, 2009