Status:
COMPLETED
A Trial of Oral Misoprostol for Labor Augmentation
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Labor Augmentation
Eligibility:
FEMALE
16+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00906347
Start Date
December 1 2008
End Date
January 1 2011
Last Update
November 15 2012
Active Locations (1)
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1
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390