A Trial of Oral Misoprostol for Labor Augmentation

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Misoprostol; Oxytocin

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

• 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