A Trial of Oral Misoprostol for Labor Augmentation

November 8, 2012 updated by: University of Texas Southwestern Medical Center

A Randomized, Controlled Trial of Oral Misoprostol for Labor Augmentation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Phase 4

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
    • Texas
      • Dallas, Texas, United States, 75390
        • The University of Texas Southwestern Medical Center

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Clinical decision to augment labor
  • Gestational age > than or equal to 36 weeks
  • Singleton gestation
  • Cephalic presentation
  • Reassuring fetal heart rate tracing
  • Cervical dilation between 4 and 8 cm
  • Ruptured membranes with clear amniotic fluid
  • Intrauterine pressure catheter in place
  • Less than 200 MVUs in a 10 minute period
  • 5 or fewer contractions in a 10 minute period
  • English or Spanish speaking patient

Exclusion Criteria:

  • Non-reassuring fetal heart rate tracing at time of enrollment
  • Meconium stained amniotic fluid
  • Previous uterine incision
  • Maternal fever (defined as greater than 37.9 C)
  • Known fetal anomalies
  • Placenta previa or unexplained vaginal bleeding
  • Estimated fetal weight of 4,500 grams or more
  • Abnormal maternal bony pelvis
  • Grandmultiparity

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxytocin augmentation
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Drug: Oxytocin
Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital
Other Names:
  • Pitocin
Active Comparator: Misoprostol augmentation
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Drug: Misoprostol
75 micrograms orally every 4 hours for up to 2 doses.
Other Names:
  • Cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uterine Tachysystole
Time Frame: Up to four hours after administration of study drug
Defined as six contractions in two consecutive 10-minute periods
Up to four hours after administration of study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant Apgar Score <4
Time Frame: 5 minutes after delivery
Assigned on a scale of 0-10 by pediatric provider attending delivery. A lower score reflects need for further resuscitation and is potentially associated with increased risk of adverse neurological outcomes.
5 minutes after delivery
Umbilical Cord Artery pH <7.1
Time Frame: Obtained at delivery
Obtained at delivery
Admission of Neonatal Intensive Care Unit
Time Frame: Until hospital discharge
Until hospital discharge
Maternal Chorioamnionitis
Time Frame: During labor
Temperature 38 degrees C or higher in the absence of other sources of infection
During labor
Maternal Hypovolemia Requiring Blood Transfusion
Time Frame: Until hospital discharge
Until hospital discharge
Method of Delivery
Time Frame: At delivery
At delivery
Time Elapsed From Start of Labor Augmentation to Delivery
Time Frame: Initiation of augmentation until delivery
Initiation of augmentation until delivery

Collaborators and Investigators

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

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: April Bleich, MD, University of Texas Southwestern Medical Center
  • Study Director: Kenneth Leveno, MD, University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2008

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 20, 2009

First Posted (Estimate)

May 21, 2009

Study Record Updates

Last Update Posted (Estimate)

November 15, 2012

Last Update Submitted That Met QC Criteria

November 8, 2012

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102008-030

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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