A Trial of Oral Misoprostol for Labor Augmentation

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Labor Augmentation

Treatments: Drug: Oxytocin; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT00906347

102008-030

Details and patient eligibility

About

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.

Enrollment: 350 patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Oxytocin augmentation

Active Comparator group

Description:

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

Treatment:

Drug: Oxytocin

Misoprostol augmentation

Active Comparator group

Description:

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

Treatment:

Drug: Misoprostol