Status:
COMPLETED
Oral Misoprostol for Labor Augmentation: A Pilot Study
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Arrest of Dilation in Labor
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00906126
Start Date
April 1 2007
End Date
May 1 2009
Last Update
May 21 2009
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390