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

Saskatchewan Health Authority

Status: Completed

Conditions: Labor, Induced; Obesity; Pregnancy

Treatments: Drug: Dinoprostone; Device: Single balloon foley catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT01962831

REB-13-51

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

dinoprostone

Experimental group

Description:

Group of women that will receive dinoprostone for induction of labour dinoprostone 10 mg in vagina to be reassessed every 24 hours

Treatment:

Drug: Dinoprostone

Single balloon foley catheter

Experimental group

Description:

Group of women that will have a single balloon foley catheter inserted for induction of labour

Treatment:

Device: Single balloon foley catheter