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

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

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Key information

Conditions

Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

St Luke's Hosptial & Health Network

Bethlehem, Pennsylvania, 18015, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Term pregnancy scheduled for induction of labor

Exclusion criteria

Preterm pregnancy that require induction for fetal indications

Treatment and study plan

foley balloon only

Device

place foley balloon only in cervix

foley balloon with weight attached

Device

foley balloon with 1000cc IV bag attached

Primary outcomes

Time to effectively ripen cervix

Time frame: to effective cervical ripening

Sponsors and collaborators

Lead sponsor

St. Luke's Hospital, Pennsylvania

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Feb 5, 2010
Registry last updated: Apr 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed