At a glance
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Tension Versus Tension-Free Foley Balloon for Cervical Ripening in Nulliparous Women Undergoing Induction of Labor: A Cluster Randomized Controlled Trial
In Brief
A clinical study evaluating Placement of Foley balloon for cervical ripening with tension. and Placement of Foley balloon for cervical ripening without tension. for Induced Vaginal Delivery. Completed, enrolled 279 participants across 1 site.
Detailed Summary
Foley balloons are commonly used as a mechanical method of cervical ripening for induction of labor. Foley balloons may be placed either under tension or without tension (tension-free). The purpose of our study is to examine time to delivery in nulliparous women undergoing induction of labor who have a Foley balloon placed as a mechanical cervical dilator, assigned to either tension or without tension. The goal is to determine if there is a potential added benefit to placing the Foley balloon on tension as compared to no tension. Our hypothesis is that Foley balloon under tension for cervical ripening results in shorter time to vaginal delivery compared to Foley balloon placed without tension.
Study Details
Timeline
Interventions
A Foley balloon will be placed for cervical ripening with tension.
A Foley balloon will be placed for cervical ripening without tension.