Comparison of Foley Balloon With or Without Traction for the Cervical Ripening

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by St. Luke's Hospital, Pennsylvania
Sponsor:
Information provided by (Responsible Party):
James Anasti, MD, St. Luke's Hospital, Pennsylvania
ClinicalTrials.gov Identifier:
NCT01063244
First received: February 3, 2010
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

We will compare the use of foley bulb catheters placed in the cervix for ripening of the cervix for labor induction,.


Condition Intervention Phase
Cervical Ripening
Device: foley balloon only
Device: foley balloon with weight attached
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Foley Balloon With or Without Traction for the Cervical Ripening

Further study details as provided by St. Luke's Hospital, Pennsylvania:

Primary Outcome Measures:
  • Time to effectively ripen cervix [ Time Frame: to effective cervical ripening ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: January 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: foley balloon only
Foley balloon only placed in cervix
Device: foley balloon only
place foley balloon only in cervix
Experimental: Foley balloon with a weight attached
addition of a 1000 cc IV bag weight to foley balloon in cervix
Device: foley balloon with weight attached
foley balloon with weight attached

Detailed Description:

One arm will have the foley balloon placed alone in the cervix. And one arm will have the foley balloon placed in the cervix and then attached to a weight (1000 cc Iv Bag of fluid). Our hypothesis is that the weighted balloon will be more effective than the non-weighted balloon in the ripening of the cervix for induction of labor

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Term pregnancy scheduled for induction of labor

Exclusion Criteria:

  • Preterm pregnancy that require induction for fetal indications
  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: NCT01063244

Locations
United States, Pennsylvania
St Luke's Hosptial & Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: James N Anasti, MD    610-954-4670      
Contact: Peter Robson, MD    610-954-4670      
Principal Investigator: Peter Robson, MD         
Sponsors and Collaborators
St. Luke's Hospital, Pennsylvania
Investigators
Principal Investigator: James N Aansti, MD St Luke's Hospital
  More Information

No publications provided

Responsible Party: James Anasti, MD, Director, OB?GYN Residency Program, St. Luke's Hospital, Pennsylvania
ClinicalTrials.gov Identifier: NCT01063244     History of Changes
Other Study ID Numbers: SLHN-08-21
Study First Received: February 3, 2010
Last Updated: May 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's Hospital, Pennsylvania:
pregnancy
induction of Labor
Cervical ripening
Foley balloon

ClinicalTrials.gov processed this record on October 23, 2014