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A Randomized Trial of Induction Versus Expectant Management

NCT01990612 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6106

Last updated 2019-02-21

Study results available
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Summary

A randomized clinical trial to assess whether elective induction of labor at 39 weeks of gestation compared with expectant management will improve outcomes.

Conditions

  • Labor and Delivery

Interventions

PROCEDURE

Elective Induction of Labor

Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • The George Washington University Biostatistics Center

    lead OTHER

Principal Investigators

  • Menachem Miodovnik, MD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  • Rebecca Clifton, PhD · The George Washington University Biostatistics Center

  • William Grobman, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-11-30
Completion
2018-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01990612 on ClinicalTrials.gov