A Trial of Oral Misoprostol for Labor Augmentation

Phase 4

Completed

• Conditions: Labor Augmentation
• Interventions: Drug: Oxytocin; Drug: Misoprostol

• Registration Number: NCT00906347
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Status Verified: 2009-05
• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-20
• Study First Posted: 2009-05-21
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2012-10-05
• Results First Submitted QC: 2012-10-05
• Results First Posted: 2012-11-07
• Last Update Submitted: 2012-11-08
• Last Update Posted: 2012-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 350

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytocin augmentation	Oxytocin	Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Misoprostol augmentation	Misoprostol	Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.

Primary Outcome Measures

Name	Time	Method
Uterine Tachysystole	Up to four hours after administration of study drug	Defined as six contractions in two consecutive 10-minute periods

Secondary Outcome Measures

Name	Time	Method
Maternal Chorioamnionitis	During labor	Temperature 38 degrees C or higher in the absence of other sources of infection
Infant Apgar Score <4	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.
Umbilical Cord Artery pH <7.1	Obtained at delivery
Admission of Neonatal Intensive Care Unit	Until hospital discharge
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

Trial Locations

Locations (1)

The University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States