Randomized Controlled Trial: Induction of Labour of Obese Women With Dinoprostone or Single Balloon Catheter
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
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Oct 2013
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedFirst Posted
Study publicly available on registry
October 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedOctober 13, 2016
October 1, 2016
2.7 years
September 19, 2013
October 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time(hours) from initiation of induction of labour to vaginal delivery
Will be assessed at the end of each vaginal delivery
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (2)
dinoprostone
EXPERIMENTALGroup of women that will receive dinoprostone for induction of labour dinoprostone 10 mg in vagina to be reassessed every 24 hours
Single balloon foley catheter
EXPERIMENTALGroup of women that will have a single balloon foley catheter inserted for induction of labour
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Induction of labour for intrauterine fetal demise
- Intrauterine growth restriction
- Suspected abruption at the start of induction
- Any contraindication for a vaginal delivery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Regina Qu'Appelle Health Region
Regina, Saskatchewan, S4P0W5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christine Lett, MD
Saskatchewan Health Authority - Regina Area
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor of Obstetrics & Gynecology, University of Saskatchewan
Study Record Dates
First Submitted
September 19, 2013
First Posted
October 14, 2013
Study Start
October 1, 2013
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
October 13, 2016
Record last verified: 2016-10