The Efficacy of Early Amniotomy for Induction of Labor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2006-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Labor, Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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Amniotomy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George A. Macones, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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701340

Identifier Type: -

Identifier Source: org_study_id