Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Labor Induction, Early Amniotomy

Intervention / Treatment
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* Procedure: Amniotomy
* Device: Foley balloon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early amniotomy<br>Subjects randomized to this arm will undergo amniotomy within 2 hours of removal of Foley balloon. | Procedure: Amniotomy<br>* Artificial rupture of amniotic membranes<br>Device: Foley balloon<br>* 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.<br>* Other names: Foley bulb;|
| Active Comparator: Delayed amniotomy<br>Subjects randomized to this arm will undergo amniotomy at least 4 hours after removal of Foley balloon. | Procedure: Amniotomy<br>* Artificial rupture of amniotic membranes<br>Device: Foley balloon<br>* 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.<br>* Other names: Foley bulb;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Foley balloon