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

This study has been completed.
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: April 14, 2016
Last verified: April 2016
  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
Pregnancy
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 ]

Enrollment: 65
Study Start Date: January 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FoleyBalloon
foley balloon placed in the cervix
Device: foley balloon only
place foley balloon only in cervix
Active Comparator: foley balloon with weight
foley balloon with weight attached
Device: foley balloon with weight attached
foley balloon with 1000cc IV bag 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   (Adult)
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01063244

Locations
United States, Pennsylvania
St Luke's Hosptial & Health Network
Bethlehem, Pennsylvania, United States, 18015
Sponsors and Collaborators
St. Luke's Hospital, Pennsylvania
Investigators
Principal Investigator: James N Aansti, MD St Luke's Hospital
  More Information

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: April 14, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on August 25, 2016