The Efficacy of Early Amniotomy for Induction of Labor

December 1, 2015 updated by: University of Pennsylvania
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of The University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: George A. Macones, MD, MSCE, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

August 19, 2005

First Submitted That Met QC Criteria

August 19, 2005

First Posted (Estimate)

August 22, 2005

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 701340

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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