Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Delayed amniotomy	Foley balloon	Subjects randomized to this arm will undergo amniotomy at least 4 hours after removal of Foley balloon.
Early amniotomy	Foley balloon	Subjects randomized to this arm will undergo amniotomy within 2 hours of removal of Foley balloon.
Delayed amniotomy	Amniotomy	Subjects randomized to this arm will undergo amniotomy at least 4 hours after removal of Foley balloon.
Early amniotomy	Amniotomy	Subjects randomized to this arm will undergo amniotomy within 2 hours of removal of Foley balloon.

Primary Outcome Measures

Name	Time	Method
Time to Active Phase of Labor	At delivery	Total time from initiation of labor induction to reaching 6 cm cervical dilation

Secondary Outcome Measures

Name	Time	Method
Time to Delivery	At delivery	Total time from initiation of labor induction to delivery
Vaginal Delivery Rate	At delivery	Rate of vaginal delivery within 24, 36, and 48 hours
Cesarean Section Rate	At delivery	Rate of cesarean section and indications
Maternal Infection Composite	From admission to discharge, up to 2 weeks	Includes isolated maternal fever, chorioamnionitis, endometritis, wound infection
Umbilical Cord Prolapse	At delivery	Rates of umbilical cord prolapse
Neonatal Outcome Composite	From admission to discharge, up to 2 weeks	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.