A Trial of Oral Misoprostol for Labor Augmentation

Completed · Phase 4

Conditions studied: Labor Augmentation

In brief

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.

Key facts

Study ID

NCT00906347

Run by

University of Texas Southwestern Medical Center

People needed

350

Starts

2008-12-01

Expected to finish

2011-01-01

Last updated by the study team

2012-11-15

Who can join

Age: 16 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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