NCT04573517

Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor

Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor: a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Amniotomy is commonly done in the management of labor, though there is little research guiding the timing of amniotomy. Recent research largely suggests a benefit to earlier amniotomy, reporting shorter labor courses with no increase in the number of cesarean deliveries. This is some research, however, that reports an increase in cesarean deliveries with early amniotomy. Due to the small number of studies evaluating this topic, as well as the conflicting results, more research is needed. Additionally, the method of cervical ripening prior to amniotomy should be accounted for, as it may have an impact on the overall labor course. The purpose of this study is to evaluate the impact of early versus delayed amniotomy on time of delivery time from induction to the active phase of labor, as well on total time to delivery and maternal and neonatal outcomes in women undergoing cervical ripening with the Foley balloon.

Detailed description

This will be an unblinded randomized clinical trial. The investigators will recruit 174 pregnant women undergoing induction of labor. Recruitment will occur on the Labor and Delivery unit at the time of induction, after the decision has been made to place a Foley balloon for cervical ripening. Enrolled subjects will be randomized to early or delayed amniotomy. Subjects randomized to early amniotomy will undergo amniotomy within 2 hours of Foley balloon removal. Subjects randomized to delayed amniotomy will undergo amniotomy at least 4 hours after Foley balloon removal.

Conditions

• Labor Induction
• Early Amniotomy

Interventions

Type	Name	Description
PROCEDURE	Amniotomy	Artificial rupture of amniotic membranes
DEVICE	Foley balloon	The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours.

Timeline

• Start date: 2020-10-15
• Primary completion: 2023-06-22
• Completion: 2023-06-22
• First posted: 2020-10-05
• Last updated: 2025-03-04
• Results posted: 2025-03-04

Locations

1 site across 1 country: United States