Clinical trial NCT04573517: Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor
Official title: Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Induction
Early Amniotomy
Keywords: Foley balloon
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Active Phase of Labor
timeFrame: At delivery
Secondary outcomes:
measure: Time to Delivery
timeFrame: At delivery
measure: Vaginal Delivery Rate
timeFrame: At delivery
measure: Cesarean Section Rate
timeFrame: At delivery
measure: Maternal Infection Composite
timeFrame: From admission to discharge, up to 2 weeks
measure: Umbilical Cord Prolapse
timeFrame: At delivery
measure: Neonatal Outcome Composite
timeFrame: From admission to discharge, up to 2 weeks
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Marissa Berry, MD
role: PRINCIPAL_INVESTIGATOR
References: