A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter - Full Text View

Sponsored by:	Western Galilee Hospital-Nahariya
Information provided by:	Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:	NCT00501033

Purpose

Hypothesis: The induction of labor in patients with unfavorable Bishop score is a challenging obstetrical process, and may be influenced or complicated by the cervical ripening method used. We will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis.

Condition	Intervention
Induction of Labor Cesarean Endometritis	Device: Mechanical induction of labor Device: Double Balloon Device: Foley Catheter

MedlinePlus related topics: Cesarean Section

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter

Further study details as provided by Western Galilee Hospital-Nahariya:

Primary Outcome Measures:

Success of labor induction [ Time Frame: Postpartum period ]

Secondary Outcome Measures:

Postpartum endometritis rate [ Time Frame: The postpartum period ]
Cesarean section rate [ Time Frame: Delivery ]

Estimated Enrollment:	200
Study Start Date:	January 2006
Study Completion Date:	May 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Detailed Description:

We will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis. The study will include 200 parturients, 100 primiparous and 100 multiparous women. We will randomize each group to induction with the foley catheter or the cervical ripening double balloon. We will compare the failure rates, cesarean section rate, infectious and other postpartum complications, especially endometritis.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Term pregnancy
Parturients candidates for mechanical induction of labor

Exclusion Criteria:

Suspected amnionitis
Vaginal discharge
Pre induction pyrexia
Immunocompromised parturients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501033

Locations

Israel
Western Galilee Hospital
Nahariya, Israel, 22100

Sponsors and Collaborators

Western Galilee Hospital-Nahariya

Investigators

Principal Investigator:

Ido Solt, MD

Western Galilee Hospital

More Information

Responsible Party:	Western Galilee Hospital ( Professor Jacob Bornstein )
Study ID Numbers:	4
Study First Received:	July 12, 2007
Last Updated:	May 2, 2008
ClinicalTrials.gov Identifier:	NCT00501033
Health Authority:	Israel: Ministry of Health; United States: Food and Drug Administration

Keywords provided by Western Galilee Hospital-Nahariya:

Induction of labor
Cesarean
Endometritis
Foley
Infections

Study placed in the following topic categories:

Genital Diseases, Female
Endometritis
Uterine Diseases
Pelvic Inflammatory Disease

Additional relevant MeSH terms:

Adnexal Diseases

ClinicalTrials.gov processed this record on January 14, 2009