Oral Misoprostol for Labor Augmentation: A Pilot Study

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

A phase I, open-label trial to determine a safe dose of oral misoprostol required to augment labor in nulliparous women diagnosed with arrest of dilation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• nulliparous

• gestational age of at least 36 weeks

• singleton gestation

• cephalic presentation

• reassuring fetal heart rate

• 4 cm or greater cervical dilation

• ruptured membranes with clear amnionic fluid

• intrauterine pressure catheter in place

• less than 200 MVU's

Exclusion Criteria:

• non-reassuring fetal heart rate

• meconium-stained amnionic fluid

• previous uterine incision

• maternal fever

• pregnancy-induced hypertension or other pregnancy-related complications

• known fetal anomalies

• placenta previa or unexplained vaginal bleeding

• estimated fetal weight of 4,500 grams or greater

• evidence of cephalopelvic disproportion

• any moderate or severe preexisting disease

• contraindication to the use of prostaglandins