Tension Versus Tension- Free Foley Balloon for Cervical Ripening

Study Overview
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Brief Summary
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Foley balloons are commonly used as a mechanical method of cervical ripening for induction of labor. Foley balloons may be placed either under tension or without tension (tension-free). The purpose of our study is to examine time to delivery in nulliparous women undergoing induction of labor who have a Foley balloon placed as a mechanical cervical dilator, assigned to either tension or without tension. The goal is to determine if there is a potential added benefit to placing the Foley balloon on tension as compared to no tension. Our hypothesis is that Foley balloon under tension for cervical ripening results in shorter time to vaginal delivery compared to Foley balloon placed without tension.

Detailed Description
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This is a pragmatic cluster randomized clinical trial. The target population is nulliparous women who present for induction of labor at term. If there is a decision by the obstetric team to place a transcervical Foley dilator for cervical ripening in a prospective subject meeting inclusion criteria for the study, the obstetric provider will follow the weekly randomization sequence for study group (No Tension) or the control group (Tension) based on the assigned cluster for the entire unit for that week. Both study groups will receive standardized labor management as Foley balloon placed with tension and without tension are both considered standard of care at our institution. The Tension standard of care (control group) will undergo induction of labor by placement of a transcervical Foley balloon, which is standard of care at our institution. The balloon tubing will be pulled to create tension and will then be taped to the patient's inner thigh. The No Tension standard of care (study group) will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be left free of tension and will hang freely. Subjects in the control and study group will then undergo standard intrapartum care. The total participation time in the study will be considered terminated following delivery.

Official Title
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Tension Versus Tension-Free Foley Balloon for Cervical Ripening in Nulliparous Women Undergoing Induction of Labor: A Cluster Randomized Controlled Trial

Conditions
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Induced Vaginal Delivery

Intervention / Treatment
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* Other: Placement of Foley balloon for cervical ripening with tension.
* Other: Placement of Foley balloon for cervical ripening without tension.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Term induction of labor Nulliparous Vertex Singleton Plan for Foley balloon placement by the managing obstetrics team Cervical exam less than 3 cm dilated and less than or equal to 60% effaced Exclusion Criteria: Patient unwilling or unable to provide verbal consent Fetal demise or major congenital anomaly Preterm (<37 0/7weeks) Multiple gestation Previous uterine surgery Abnormal placentation Malpresentation Magnesium infusion for preeclampsia with severe features Prelabor rupture of membranes Fetal growth restriction Non-reassuring fetal heart rate tracing prior to inclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Without tension (tension free)<br>The study group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be left free of tension and will hang freely. | Other: Placement of Foley balloon for cervical ripening without tension.<br>* A Foley balloon will be placed for cervical ripening without tension.<br>|
| Active Comparator: Tension<br>The control group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be pulled to create tension and will then be taped to the patient's inner thigh. | Other: Placement of Foley balloon for cervical ripening with tension.<br>* A Foley balloon will be placed for cervical ripening with tension.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to vaginal delivery | Time to vaginal delivery measured from time of initial Foley balloon placement to delivery | Foley bulb placement to vaginal delivery (minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Request for analgesia following placement of the Foley balloon | Request for IV pain medications or epidural following placement of Foley balloon | Placement of Foley balloon until removal of Foley balloon in minutes (up to 12 hours) | 
| Incidence of primary cesarean delivery | Incidence of primary cesarean delivery | Placement of Foley balloon until cesarean delivery if applicable | 
| Incidence of postpartum hemorrhage | Incidence of postpartum hemorrhage | Placement of Foley balloon until 24 hours postpartum | 
| Incidence of chorioamnionitis | Incidence of chorioamnionitis | Placement of Foley balloon until delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Induced Vaginal Delivery, Cervical Ripening, Mechanical Cervical Ripening