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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01063244
First Posted: February 5, 2010
Last Update Posted: April 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
James Anasti, MD, St. Luke's Hospital, Pennsylvania
  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
Intervention Model: Parallel Assignment
Masking: None (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 James Anasti, MD, St. Luke's Hospital, Pennsylvania:

Primary Outcome Measures:
  • Time to effectively ripen cervix [ Time Frame: to effective cervical ripening ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

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): 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
First Submitted: February 3, 2010
First Posted: February 5, 2010
Last Update Posted: April 18, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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