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

NCT ID: NCT01962831

Last Updated: 2016-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-06-30

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.

Detailed Description

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Conditions

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Obesity Pregnancy Labor, Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dinoprostone

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

Group Type EXPERIMENTAL

Dinoprostone

Intervention Type DRUG

Single balloon foley catheter

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

Group Type EXPERIMENTAL

Single balloon foley catheter

Intervention Type DEVICE

Interventions

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Dinoprostone

Intervention Type DRUG

Single balloon foley catheter

Intervention Type DEVICE

Other Intervention Names

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Cervidil

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Saskatchewan Health Authority - Regina Area

OTHER

Sponsor Role lead

Responsible Party

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Dr. Christine Lett

Clinical Assistant Professor of Obstetrics & Gynecology, University of Saskatchewan

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christine Lett, MD

Role: PRINCIPAL_INVESTIGATOR

Saskatchewan Health Authority - Regina Area

Locations

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Regina Qu'Appelle Health Region

Regina, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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REB-13-51

Identifier Type: -

Identifier Source: org_study_id

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