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

Phase 3

Completed

• Conditions: Pregnancy

• Registration Number: NCT01063244
• Lead Sponsor: St. Luke's Hospital, Pennsylvania

Brief Summary

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

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

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-02-03
• Study First Submitted QC: 2010-02-04
• Study First Posted: 2010-02-05
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-14
• Last Update Posted: 2016-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

Inclusion Criteria

• Term pregnancy scheduled for induction of labor

Exclusion Criteria

• Preterm pregnancy that require induction for fetal indications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to effectively ripen cervix	to effective cervical ripening

Trial Locations

Locations (1)

St Luke's Hosptial & Health Network; 🇺🇸 Bethlehem, Pennsylvania, United States