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The Efficacy of Early Amniotomy for Induction of Labor

Not Applicable
Withdrawn
Conditions
Labor, Induced
Registration Number
NCT00133016
Lead Sponsor
University of Pennsylvania
Brief Summary

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

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
Female
Target Recruitment
Not specified
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

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