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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01962831
• Other study ID #: REB-13-51
• Status: Completed
• Phase: N/A
• First received: September 19, 2013
• Last updated: October 12, 2016
• Start date: October 2013
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Regina Qu'Appelle Health Region
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor, Induced
• Obesity
• Pregnancy

Intervention

Drug:
• Dinoprostone

Device:
• Single balloon foley catheter

Locations

Country	Name	City	State
Canada	Regina Qu'Appelle Health Region	Regina	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
Regina Qu'Appelle Health Region

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time(hours) from initiation of induction of labour to vaginal delivery		Will be assessed at the end of each vaginal delivery	No
Secondary	Number of vaginal deliveries within 24 hours in each group		2 years	No
Secondary	Number of cesarean sections in each group		2 years	No
Secondary	Number of operative vaginal deliveries in each group		2 years	No
Secondary	Number of chorioamnionitis cases in each group		2 years	No
Secondary	Number of patients that required oxytocin administration in each group		2 years	No
Secondary	Number of patients that required an epidural in each group		2 years	No
Secondary	Number of babies that required neonatal intensive care unit (NICU) admission in each group		2 years	No
Secondary	Number of babies that had an arterial pH <7 in each group		2 years	No
Secondary	Number of babies that had an APGAR score <7 at 5 minutes		2 years	No