Status:
TERMINATED
Foley Catheter for Labor Induction in Women With Term and Near Term Membrane Rupture
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Fetal Membranes, Premature Rupture
Labor, Induced/IS
Eligibility:
FEMALE
12-55 years
Phase:
NA
Brief Summary
In women undergoing labor induction for membrane rupture at or near term, we are investigating the addition of a foley catheter placed in the cervix to standard therapy (oxytocin administration) to de...
Detailed Description
To compare the efficacy of a transcervical Foley catheter with concurrent oxytocin administration compared to oxytocin infusion alone for cervical ripening and labor induction in women with premature ...
Eligibility Criteria
Inclusion
- Preterm rupture of membranes (PROM) (Rupture of membranes = pooling/ferning/nitrazine +) Rupture of membranes (ROM) for ≥1 hour prior to starting induction
- Cervix ≤ 2 centimeters (cm)
- Gestational age ≥ 34 weeks by best obstetric estimate and clinical management decision is delivery
- Singleton gestation
- Cephalic
- Vertex well applied to cervix
Exclusion
- Regular uterine contractions (contractions more frequent than every 5 minutes)
- Two prior transverse uterine incisions/vertical uterine incision/ transmural myomectomy or any obstetric contraindication to labor
- Evidence of chorioamnionitis (temperature of 100.4°F with uterine tenderness and maternal or fetal tachycardia or purulent discharge)
- Lethal fetal anomalies
- Intrauterine fetal demise (IUFD)
- Previa
- Suspected abruption/significant hemorrhage
- Non-reassuring fetal heart rate (FHR) pattern
- Non vertex fetal presentation
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT00290199
Start Date
December 1 2005
End Date
May 1 2008
Last Update
May 23 2017
Active Locations (3)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
Christiana Care Health System
Newark, Delaware, United States, 19713
3
Greenville Hospital System University Medical Center
Greenville, South Carolina, United States, 29605