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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Labor Induction; Early Amniotomy
• Intervention / Treatment: Procedure: Amniotomy; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marissa Berry, MD; Phone Number: 4097474952; Email: majberry@utmb.edu
• Study Contact Backup: Name: Antonio F Saad, MD; Email: afsaad@utmb.edu

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77550
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18
• Singleton pregnancy
• Term gestation (37 weeks gestation)
• Cephalic presentation
• Undergoing labor induction with transcervical Foley balloon

Exclusion Criteria:

• Previous uterine surgery
• Prelabor rupture of membranes
• Severe pre-eclampsia, HELLP, or eclampsia
• HIV, HCV, or HBV
• Heart disease
• Fever (≥38 0C) at admission
• Category II or III fetal heart rate tracing prior to randomization
• Polyhydramnios
• Fetal growth restriction <3%
• EFW > 4200 g
• Fetal demise or major congenital anomaly
• Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early amniotomy; Subjects randomized to this arm will undergo amniotomy within 2 hours of removal of Foley balloon.	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.; Other Names: Foley catheter; Foley bulb
Active Comparator: Delayed amniotomy; Subjects randomized to this arm will undergo amniotomy at least 4 hours after removal of Foley balloon.	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.; Other Names: Foley catheter; Foley bulb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to active phase of labor	Total time from initiation of labor induction to reaching 6 cm cervical dilation	At delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to delivery	Total time from initiation of labor induction to delivery	At delivery
Vaginal delivery rate	Rate of vaginal delivery within 24, 36, and 48 hours	At delivery
Cesarean section rate	Rate of cesarean section and indications	At delivery
Maternal infection composite	Includes isolated maternal fever, chorioamnionitis, endometritis, wound infection	From admission to discharge, up to 2 weeks
Umbilical cord prolapse	Rates of umbilical cord prolapse	At delivery
Neonatal outcome composite	Neonatal outcome composite including NICU admission, respiratory support, hypoxic ischemic encephalopathy, seizures, sepsis, meconium aspiration syndrome, birth trauma, intracranial or subgaleal hemorrhage, hypotension requiring pressors, and perinatal death.	From admission to discharge, up to 2 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Marissa Berry, MD, University of Texas

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): March 17, 2023
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Foley balloon
• Other Study ID Numbers: 20-0163; VUID-01165 (Other Identifier: Velos)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No