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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00290199
Other study ID # F051021005
Secondary ID
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


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
See also
  Status Clinical Trial Phase
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Completed NCT02901795 - Early Detection of Chorioamnionitis in Preterm Premature Rupture of Membranes
Not yet recruiting NCT00247104 - The Use of Cranberries in Women With Preterm Premature Rupture of Membranes N/A
Not yet recruiting NCT06262308 - Emotional Support for Women Experiencing PPROM N/A
Recruiting NCT02380560 - Myometrial Thickness as a Predictor for the Latency Interval in PPROM N/A
Completed NCT00070746 - Perinatal Infections in Pakistan N/A
Recruiting NCT02997345 - PPROM Registry (Preterm Premature Rupture of Membranes)
Terminated NCT00259519 - Safety and Efficacy Study of Intentional Delivery in Women With Preterm and Prelabour Rupture of the Membranes N/A
Recruiting NCT02369601 - PROMComplete for Determination of Rupture of Fetal Membranes
Terminated NCT00890630 - Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term Phase 2
Withdrawn NCT01063686 - The Cervical Cap in the Diagnosis of Rupture of Membranes in the Second Trimester N/A
Not yet recruiting NCT00432588 - Comparing the Effect of Vaginal Misoprostol With Dinoprostone in Term Pregnancies Phase 1/Phase 2