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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01962831
Other study ID # REB-13-51
Secondary ID
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


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
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