Foley Catheter Versus Cervidil for Induction of Labor at Term
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|ClinicalTrials.gov Identifier: NCT01402050|
Recruitment Status : Completed
First Posted : July 26, 2011
Results First Posted : February 6, 2020
Last Update Posted : March 2, 2020
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OBJECTIVE: To assess the efficacy of transcervical Foley catheter compared to controlled release prostaglandin (Cervidil™) for cervical ripening in term and near term women presenting for labor induction.
HYPOTHESIS: In term and near term women presenting for labor induction, transcervical Foley catheter will decrease the mean time from induction to delivery by six hours compared to controlled release prostaglandin (Cervidil™).
|Condition or disease||Intervention/treatment||Phase|
|Labor Induction||Drug: CERVIDIL (Dinoprostone) Device: FOLEY BALLOON||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||376 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of Transcervical Foley Balloon Compared to Controlled Release Prostaglandin (Cervidil) for Labor Induction and Cervical Ripening in Term and Near Term Women|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||February 2015|
Active Comparator: FOLEY BALLOON
Comparing foley balloon to cervidil for decreased time from the start of the induction process to delivery
Device: FOLEY BALLOON
INDUCTION OF LABOR
|Active Comparator: CERVIDIL||
Drug: CERVIDIL (Dinoprostone)
INDUCTION OF LABOR
- Time Of Start Of Induction Of Labor To Delivery [ Time Frame: Hours ]
The primary outcome variable was time (measured in hours) from first attempt at study agent placement to delivery. Time of placement of Labor Induction agent was noted as the time of Labor Induction initiation and time of delivery was noted as the end time of Labor Induction.
There were no specific time points at which the outcomes were measured due to the uncertainty of the labor process. Total time duration of Labor induction was noted in hours.
Key word: INDUCTION OF LABOR
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|Ages Eligible for Study:||18 Years to 45 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- Cervix < 3 cm dilated. If 2cm dilated, must be < 80% effaced.
- Gestational age ≥ 36 weeks by best obstetric estimate, and clinical management decision is delivery.
- Singleton gestation
- Cephalic presentation
- Regular uterine contractions (more frequent than every 5 minutes)
- Prior transverse uterine incision or any obstetric contraindication to labor
- Fever (defined as a temperature of 38°C or higher)
- Lethal fetal anomalies (Labor induction is being performed, but there is no plan for fetal heart rate monitoring or cesarean delivery for fetal indications.)
- Fetal death
- Placenta previa
- Suspected placental abruption or undiagnosed bleeding characterized as more than "spotting"
- Non-reassuring fetal heart rate pattern
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402050
|United States, Arizona|
|Banner Desert Medical Center|
|Mesa, Arizona, United States, 85210|
|Banner Good Samaritan Medical Center|
|Phoenix, Arizona, United States, 85006|
|Principal Investigator:||Monique G Lin, MD||Obstetrix Medical Group|
|Other Study ID Numbers:||
|First Posted:||July 26, 2011 Key Record Dates|
|Results First Posted:||February 6, 2020|
|Last Update Posted:||March 2, 2020|
|Last Verified:||February 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Time from the start of the induction to delivery
Reproductive Control Agents
Physiological Effects of Drugs