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

October 12, 2016 updated by: Dr. Christine Lett, Saskatchewan Health Authority - Regina Area

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P0W5
        • Regina Qu'Appelle Health Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dinoprostone
Group of women that will receive dinoprostone for induction of labour dinoprostone 10 mg in vagina to be reassessed every 24 hours
Other Names:
  • Cervidil
Experimental: Single balloon foley catheter
Group of women that will have a single balloon foley catheter inserted for induction of labour

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christine Lett, MD, Saskatchewan Health Authority - Regina Area

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

September 19, 2013

First Submitted That Met QC Criteria

October 10, 2013

First Posted (Estimate)

October 14, 2013

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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