A Trial of Oral Misoprostol for Labor Augmentation

NCT00906347 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2012-11-15

Study results available
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Summary

This is a prospective, randomized, controlled trial designed to examine the efficacy of oral misoprostol for labor augmentation compared to a standard regimen of intravenous oxytocin.

Conditions

  • Labor Augmentation

Interventions

DRUG

Misoprostol

75 micrograms orally every 4 hours for up to 2 doses.

DRUG

Oxytocin

Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • April Bleich, MD · University of Texas Southwestern Medical Center

  • Kenneth Leveno, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

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Entities

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 NCT00906347 on ClinicalTrials.gov