Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor

Labor Induction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04573517
• Other study ID #: 20-0163
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: May 2023
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: September 1, 2023
• Est. primary completion date: March 17, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Early Amniotomy
• Labor Induction

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to active phase of labor	Total time from initiation of labor induction to reaching 6 cm cervical dilation	At delivery
Secondary	Time to delivery	Total time from initiation of labor induction to delivery	At delivery
Secondary	Vaginal delivery rate	Rate of vaginal delivery within 24, 36, and 48 hours	At delivery
Secondary	Cesarean section rate	Rate of cesarean section and indications	At delivery
Secondary	Maternal infection composite	Includes isolated maternal fever, chorioamnionitis, endometritis, wound infection	From admission to discharge, up to 2 weeks
Secondary	Umbilical cord prolapse	Rates of umbilical cord prolapse	At delivery
Secondary	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