Foley Catheter for Labor Induction in Women With Term and Near Term Membrane Rupture
This study has been terminated.
(Gathering information from the PI records to provide this response.)
Sponsor:
University of Alabama at Birmingham
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00290199
First received: February 9, 2006
Last updated: September 29, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fetal Membranes, Premature Rupture Labor, Induced/IS |
Device: Transcervical Foley catheter |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Trial of Foley Catheter for Labor Induction in Women With Term and Near Term Prelabor Rupture of Membranes (PROM) |
Further study details as provided by University of Alabama at Birmingham:
Primary Outcome Measures:
- Hours From Placement of Foley or Initiation of Oxytocin to Delivery (up to 24 Hours) [ Time Frame: Time from induction to delivery ] [ Designated as safety issue: No ]The outcome measure is the mean in hours of the time from induction to delivery
Secondary Outcome Measures:
- Rate of Delivery (Vaginal or Cesarean)by 24 Hours [ Time Frame: from start of induction to 24 hours post start of induction ] [ Designated as safety issue: Yes ]The percent of subjects having transcervical foley catheter and percent of subjects not having transcervical foley catheter delivering within 24 hours.
- Cesarean Rate [ Time Frame: at delivery ] [ Designated as safety issue: No ]The percent of subjects enrolled who had a cesarean at any time for any reason for delivery.
- Induction to Vaginal Delivery Interval [ Time Frame: time from induction to vaginal delivery, up to 24 hours ] [ Designated as safety issue: No ]Mean hours from time of induction to vaginal delivery interval.
| Enrollment: | 169 |
| Study Start Date: | December 2005 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Transcervical Foley |
Device: Transcervical Foley catheter
Foley catheter placed through cervix for cervical ripening
|
| No Intervention: No Foley |
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| Ages Eligible for Study: | 12 Years to 55 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290199
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35249 | |
| United States, Delaware | |
| Christiana Care Health System | |
| Newark, Delaware, United States, 19713 | |
| United States, South Carolina | |
| Greenville Hospital System University Medical Center | |
| Greenville, South Carolina, United States, 29605 | |
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
| Principal Investigator: | Monique G Lin, MD | University of Alabama at Birmingham |
| Principal Investigator: | Patrick S Ramsey, MD, MSPH | University of Alabama at Birmingham |
More Information
Publications:
| Responsible Party: | University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00290199 History of Changes |
| Other Study ID Numbers: | F051021005 |
| Study First Received: | February 9, 2006 |
| Results First Received: | June 1, 2012 |
| Last Updated: | September 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Alabama at Birmingham:
|
Fetal Membranes, Premature Rupture Labor, Induced Foley Catheter |
Additional relevant MeSH terms:
|
Fetal Membranes, Premature Rupture Rupture Obstetric Labor Complications Pregnancy Complications Wounds and Injuries |
ClinicalTrials.gov processed this record on June 18, 2013