The Efficacy of Early Amniotomy for Induction of Labor

This study has been terminated.

Sponsored by:	University of Pennsylvania
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00133016

Purpose

The purpose of this clinical trial is to investigate the efficacy of early amniotomy on reducing both the duration of labor and the frequency of dystocia in nulliparous women undergoing an induction of labor. This research project is a prospective, parallel clinical trial, in which subjects are randomized into one of two treatment groups: those who undergo early amniotomy and those who do not undergo early artificial rupture of the amniotic membranes.

Condition	Intervention
Labor, Induced	Procedure: Amniotomy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Efficacy of Early Amniotomy for Induction of Labor

Eligibility

Genders Eligible for Study:

Female

Criteria

Inclusion Criteria:

Gestational age > 37 weeks (using established National Institute of Child Health and Human Development [NICHD] dating criteria)
Nulliparous (i.e., first term pregnancy)
Admitted to the hospital for induction of labor
Singleton pregnancy
Fetal head applied to the cervix
The ability to understand the requirements of the study, as determined by the study nurse

Exclusion Criteria:

Premature rupture of amniotic membranes
Cervical dilation > 4 cm
Vaginal bleeding
Major fetal abnormalities that are known at time of admission

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133016

Locations

United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

Investigators

Principal Investigator:

George A. Macones, MD, MSCE

University of Pennsylvania

More Information

Study ID Numbers:	701340
Study First Received:	August 19, 2005
Last Updated:	September 6, 2006
ClinicalTrials.gov Identifier:	NCT00133016
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

Induction of labor

ClinicalTrials.gov processed this record on January 14, 2009