Status:
COMPLETED
Foley OR MisO for the Management of Induction
Lead Sponsor:
University of Pennsylvania
Conditions:
Delivery; Prolonged
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The percentage of women undergoing an induction of labor (IOL) is estimated to be 20% and continues to rise. Simultaneously, the cesarean delivery (CD) rate has continued to increase (2). Induction is...
Detailed Description
Prolonged labor increases the risk of maternal and neonatal morbidity as well as increases healthcare costs. There is limited data evaluating the use of two simultaneous induction agents to decrease t...
Eligibility Criteria
Inclusion
- All women 18 years of age or greater
- singleton gestation
- vertex presentation
- 37 weeks gestational age or greater
- undergoing an IOL
- bishop score less than or equal to 6
- cervical dilation less than or equal to 2cm
Exclusion
- All women less than 18 years of age
- Contraindication for vaginal delivery
- Prior cesarean delivery
- Multiple gestation
- Intrauterine fetal demise
- Fetal anomaly
- HIV
- Unable to consent/ non-English speaking
- Non-reassuring fetal heart rate
- Patients with hemolysis elevated liver enzymes and low platelets
- Eclampsia
- Intrauterine growth restriction (IUGR) 5th percentile with abnormal dopplers
- IUGR less than 10th percentile with reversed end diastolic flow
- Recurrent late decelerations w
- Continuous contractions more than 3 times in 10 minutes at onset of IOL (given that this is a contraindication to misoprostol use at our institution)
- Bishop score is greater than 6
- Cervical dilation greater than or equal to 2cm
- Confirmed ruptured membranes
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
491 Patients enrolled
Trial Details
Trial ID
NCT01916681
Start Date
May 1 2013
End Date
June 1 2015
Last Update
May 18 2017
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104