Foley Catheter for Labor Induction in Women With Term and Near Term Membrane Rupture
Stopped early · Not applicable
Conditions studied: Fetal Membranes, Premature Rupture, Labor, Induced/IS
In brief
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 decrease the time from the start of the induction to delivery.
Key facts
- Study ID
- NCT00290199
- Run by
- University of Alabama at Birmingham
- People needed
- 169
- Starts
- 2005-12-01
- Expected to finish
- 2008-05-01
- Last updated by the study team
- 2017-05-23
Who can join
Age: 12 and older, up to 55. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Christiana Care Health System — Newark, Delaware, United States
- Greenville Hospital System University Medical Center — Greenville, South Carolina, United States
Full record on ClinicalTrials.gov
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