Randomized Controlled Trial: Induction of Labour of Obese Women With Dinoprostone or Single Balloon Catheter

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy of single balloon foley catheters to dinoprostone for the induction of labour of obese women. The investigators suspect that women assigned to the foley group will have a shorter induction to delivery time than women in the dinoprostone group.

Official Title
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Randomized Controlled Trial: Single Balloon Catheter Versus Dinoprostone Vaginal Insert for Induction of Labour of Women With a BMI Equal to or Greater Than 30

Conditions
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Obesity, Pregnancy, Labor, Induced

Intervention / Treatment
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* Drug: Dinoprostone
* Device: Single balloon foley catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obese (BMI >30 before 20 weeks gestational age) Singleton pregnancy Vertex presentation Bishop Score <6 Intact membranes Gestational age 37+0 to 42+0 Normal fetal heart tracing on admission for ripening Exclusion Criteria: Induction of labour for intrauterine fetal demise Intrauterine growth restriction Suspected abruption at the start of induction Any contraindication for a vaginal delivery
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: dinoprostone<br>Group of women that will receive dinoprostone for induction of labour dinoprostone 10 mg in vagina to be reassessed every 24 hours | Drug: Dinoprostone<br> <br> * Other names: Cervidil;|
| Experimental: Single balloon foley catheter<br>Group of women that will have a single balloon foley catheter inserted for induction of labour | Device: Single balloon foley catheter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time(hours) from initiation of induction of labour to vaginal delivery |  | Will be assessed at the end of each vaginal delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of vaginal deliveries within 24 hours in each group |  | 2 years | 
| Number of cesarean sections in each group |  | 2 years | 
| Number of operative vaginal deliveries in each group |  | 2 years | 
| Number of chorioamnionitis cases in each group |  | 2 years | 
| Number of patients that required oxytocin administration in each group |  | 2 years | 
| Number of patients that required an epidural in each group |  | 2 years | 
| Number of babies that required neonatal intensive care unit (NICU) admission in each group |  | 2 years | 
| Number of babies that had an arterial pH <7 in each group |  | 2 years | 
| Number of babies that had an APGAR score <7 at 5 minutes |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, labor, induced, pregnancy, cervical ripening, dinoprostone