Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix

This study has been completed.
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00690040
First received: May 31, 2008
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

The purpose of this study is to compare between single balloon catheter and double balloon catheter for ripening the cervix among pregnant with unfavorable cervix.


Condition Intervention
Induction of Labor
Device: Foley catheter
Device: Atad catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • To compare the time duration from insertion of the catheter until delivery [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare mode of delivery, catheter's side effects and woman's satisfaction between the groups [ Time Frame: At the end of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 290
Study Start Date: June 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
Device: Foley catheter
Single balloon catheter
Active Comparator: 2
Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
Device: Atad catheter
Double balloon catheter

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Induction of labor is indicated
  • Gestational age between 24 - 42 weeks
  • Singleton pregnancy
  • Bishop score less than 7

Exclusion Criteria:

  • Any contraindication for vaginal delivery
  • Previous cesarean delivery
  • Low lying placenta
  • Rupture of membranes
  • Fetal malformations incompatible with life
  • intrauterine fetal death
  • Amnionitis
  • Genital viral infection (HIV, HCV, HBV)
  • Allergy to latex
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690040

Locations
Israel
Department of Ob/Gyn, Ha`Emek Medical Center
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Raed Salim, MD Department of Ob/Gyn, Ha`Emek Medical Center, Afula, and Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of OB/GYN, HaEmek Medical Center
ClinicalTrials.gov Identifier: NCT00690040     History of Changes
Other Study ID Numbers: 0007-08-EMC
Study First Received: May 31, 2008
Last Updated: May 18, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
Induction of labor
Ripening
Single balloon catheter
Double balloon catheter

ClinicalTrials.gov processed this record on October 01, 2014