Foley Catheter for Labor Induction in Women With Term and Near Term Membrane Rupture

Fetal Membranes, Premature Rupture Clinical Trial

Official title:

A Randomized Controlled Trial of Foley Catheter for Labor Induction in Women With Term and Near Term Prelabor Rupture of Membranes (PROM)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00290199
• Other study ID #: F051021005
• Status: Terminated
• Phase: N/A
• First received: February 9, 2006
• Last updated: September 29, 2012
• Start date: December 2005
• Est. completion date: May 2008

Study information

• Verified date: September 2012
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 169
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Labor, Induced/IS
• Rupture

Intervention

Device:
• Transcervical Foley catheter
Foley catheter placed through cervix for cervical ripening

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Greenville Hospital System University Medical Center	Greenville	South Carolina
United States	Christiana Care Health System	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hours From Placement of Foley or Initiation of Oxytocin to Delivery (up to 24 Hours)	The outcome measure is the mean in hours of the time from induction to delivery	Time from induction to delivery	No
Secondary	Rate of Delivery (Vaginal or Cesarean)by 24 Hours	The percent of subjects having transcervical foley catheter and percent of subjects not having transcervical foley catheter delivering within 24 hours.	from start of induction to 24 hours post start of induction	Yes
Secondary	Cesarean Rate	The percent of subjects enrolled who had a cesarean at any time for any reason for delivery.	at delivery	No
Secondary	Induction to Vaginal Delivery Interval	Mean hours from time of induction to vaginal delivery interval.	time from induction to vaginal delivery, up to 24 hours	No