Foley Labor Induction Trial at Term and in PROM

Study Overview
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Brief Summary
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This study is considering current standard oxytocin dosing regimen in combination with Foley bulb for cervical ripening is associated with improved outcomes including greater percentage of women delivered within or less than 24 hours. The investigators will also assess other maternal and neonatal outcomes including risk of infection (i.e. chorioamnionitis), bleeding, uterine atony, cesarean delivery and use of regional analgesia. Participants will be randomly assigned to one of the 2 arms of the study: use of oxytocin or no oxytocin while the Foley bulb is in place. As part of standard of care for inductions, Foley bulbs will be placed for all participants. Study participants who are randomly assigned to the use of oxytocin will receive oxytocin at the time the Foley bulb is placed. Study participants randomly assigned to no oxytocin will receive the oxytocin once the Foley bulb is removed. After delivery, information will be collected from participant's chart on the outcome of pregnancy such as gestational age at delivery, type of delivery (vaginal or cesarean section), and baby's outcome (such as birth weight, APGAR scores, and any complications).

Detailed Description
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Currently there is a paucity of literature to determine the efficacy of use of Pitocin during Foley placement, a single study has been published which suggests that the induction to delivery time is shortened in multiparas, but not in nulliparas. This study was not specifically powered to assess nulliparas as well, without increased risk.

Official Title
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A Randomized Trial of Foley Bulb Induction With and Without Simultaneous Use of Oxytocin

Conditions
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Induction of Labor

Intervention / Treatment
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* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women at > 24 weeks gestation a non-anomalous, singleton fetus in a vertex presentation Exclusion Criteria: history of prior uterine surgery such as cesarean section or myomectomy unexplained vaginal bleeding latex allergy contraindication to vaginal delivery (i.e. placenta previa, vasa previa, active vaginal bleeding, macrosomia etc)

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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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 |
| --- | --- |
| No Intervention: Control<br>No oxytocin while the Foley bulb is in place | |
| Experimental: Oxytocin<br>Use of oxytocin while the Foley bulb is in place | Drug: Oxytocin<br>* Use of oxytocin while the Foley bulb is in place<br>* Other names: Pitocin;|
| Experimental: PROMS Foley and oxytocin<br>Subjects who are induced due to premature rupture of membranes randomized to use of Foley bulb and oxytocin once the bulb is removed. | Drug: Oxytocin<br>* Use of oxytocin while the Foley bulb is in place<br>* Other names: Pitocin;|
| No Intervention: PROMS no Foley bulb<br>Subjects who are induced due to premature rupture of membranes randomized to no Foley bulb. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| induction time to delivery | The time from induction to delivery will be starting from the time the first induction agent is used on the patient until the official time of birth of the neonate. | Time from induction to delivery, average 12-28 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of delivery | The mode of delivery is ascertained from the delivery summary as either spontaneous vaginal delivery, cesarean delivery, vacuum assisted vaginal delivery, or forcep assisted vaginal delivery. | average of 12-28 hours from induction until official time of birth | 
| estimated blood loss |  | average of 12-28 hours from induction until official time of birth | 
| uterine atony | uterine atony is assessed by both provider report and/or the use of uterotonics as indicated by the chart. | average of 12-28 hours from induction until official time of birth | 
| chorioamnionitis | Chorioamnionitis is ascertained from provider report as fever with either maternal/fetal tachycardia, fundal tenderness, or foul smelling fluid while the patient is in labor. | average of 12-28 hours from induction until official time of birth | 
| neonatal birthweight |  | average of 12-28 hours from induction until official time of birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Induction of Labor, Pitocin, Oxytocin, Foley bulb