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

Sponsor

Saskatchewan Health Authority - Regina Area (Other)

Overall Status

Completed

CT.gov ID

NCT01962831

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Pregnancy Labor, Induced	Drug: Dinoprostone Device: Single balloon foley catheter	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

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	Drug: Dinoprostone Other Names: Cervidil
Experimental: Single balloon foley catheter Group of women that will have a single balloon foley catheter inserted for induction of labour	Device: Single balloon foley catheter

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

Drug: Dinoprostone

Other Names:

Cervidil

Experimental: Single balloon foley catheter

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

Device: Single balloon foley catheter

Outcome Measures

Primary Outcome Measures

Time(hours) from initiation of induction of labour to vaginal delivery [Will be assessed at the end of each vaginal delivery]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regina Qu'Appelle Health Region	Regina	Saskatchewan	Canada	S4P0W5

Sponsors and Collaborators

Saskatchewan Health Authority - Regina Area

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Christine Lett, Clinical Assistant Professor of Obstetrics & Gynecology, University of Saskatchewan, Saskatchewan Health Authority - Regina Area

ClinicalTrials.gov Identifier:

NCT01962831

Other Study ID Numbers:

REB-13-51

First Posted:

Oct 14, 2013

Last Update Posted:

Oct 13, 2016

Last Verified:

Oct 1, 2016

Keywords provided by Dr. Christine Lett, Clinical Assistant Professor of Obstetrics & Gynecology, University of Saskatchewan, Saskatchewan Health Authority - Regina Area

Additional relevant MeSH terms:

Obesity

Dinoprostone

Study Results

No Results Posted as of Oct 13, 2016