A Randomized, Controlled Trial of Oral Misoprostol for Labor Augmentation

University of Texas Southwestern Medical Center1 site in 1 country350 target enrollmentDecember 2008

ConditionsLabor Augmentation

InterventionsOxytocin Misoprostol

DrugsMisoprostol Oxytocin

Overview

Phase: Phase 4
Intervention: Oxytocin
Conditions: Labor Augmentation
Sponsor: University of Texas Southwestern Medical Center
Enrollment: 350
Locations: 1
Primary Endpoint: Uterine Tachysystole
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

January 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Texas Southwestern Medical Center

Responsible Party

Sponsor

Eligibility Criteria

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

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

Arms & Interventions

Oxytocin augmentation

Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.

Intervention: Oxytocin

Misoprostol augmentation

Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.

Intervention: Misoprostol

Outcomes

Primary Outcomes

Uterine Tachysystole

Time Frame: Up to four hours after administration of study drug

Defined as six contractions in two consecutive 10-minute periods

Secondary Outcomes

Infant Apgar Score <4(5 minutes after delivery)
Umbilical Cord Artery pH <7.1(Obtained at delivery)
Admission of Neonatal Intensive Care Unit(Until hospital discharge)
Maternal Chorioamnionitis(During labor)
Maternal Hypovolemia Requiring Blood Transfusion(Until hospital discharge)
Method of Delivery(At delivery)
Time Elapsed From Start of Labor Augmentation to Delivery(Initiation of augmentation until delivery)