Clinical trial NCT00290199: Foley Catheter for Labor Induction in Women With Term and Near Term Membrane Rupture
Official title: A Randomized Controlled Trial of Foley Catheter for Labor Induction in Women With Term and Near Term Prelabor Rupture of Membranes (PROM)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fetal Membranes, Premature Rupture
Labor, Induced/IS
Keywords: Fetal Membranes, Premature Rupture
Labor, Induced
Foley Catheter
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2006-02-10
Enrollment: 169
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 decrease the time from the start of the induction to delivery.

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 rupture of membranes (PROM) at \> 34 weeks.

Eligibility criteria: Inclusion Criteria:

1. Preterm rupture of membranes (PROM) (Rupture of membranes = pooling/ferning/nitrazine +) Rupture of membranes (ROM) for ≥1 hour prior to starting induction
2. Cervix ≤ 2 centimeters (cm)
3. Gestational age ≥ 34 weeks by best obstetric estimate and clinical management decision is delivery
4. Singleton gestation
5. Cephalic
6. Vertex well applied to cervix

Exclusion Criteria:

1. Regular uterine contractions (contractions more frequent than every 5 minutes)
2. Two prior transverse uterine incisions/vertical uterine incision/ transmural myomectomy or any obstetric contraindication to labor
3. Evidence of chorioamnionitis (temperature of 100.4°F with uterine tenderness and maternal or fetal tachycardia or purulent discharge)
4. Lethal fetal anomalies
5. Intrauterine fetal demise (IUFD)
6. Previa
7. Suspected abruption/significant hemorrhage
8. Non-reassuring fetal heart rate (FHR) pattern
9. Non vertex fetal presentation

Primary outcomes:
measure: Hours From Placement of Foley or Initiation of Oxytocin to Delivery
timeFrame: Time from induction to delivery
Secondary outcomes:
measure: Rate of Delivery (Vaginal or Cesarean)by 24 Hours
timeFrame: from start of induction to 24 hours post start of induction
measure: Cesarean Rate
timeFrame: at delivery
measure: Induction to Vaginal Delivery Interval
timeFrame: time from induction to vaginal delivery, up to 24 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Greenville
country: United States
facility: Greenville Hospital System University Medical Center
state: South Carolina
Study officials:
affiliation: University of Alabama at Birmingham
name: Alan T Tita, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolff K, Swahn ML, Westgren M. Balloon catheter for induction of labor in nulliparous women with prelabor rupture of the membranes at term. A preliminary report. Gynecol Obstet Invest. 1998;46(1):1-4. doi: 10.1159/000009986.