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
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Regina Qu'Appelle Health Region | Regina | Saskatchewan |
Lead Sponsor | Collaborator |
---|---|
Regina Qu'Appelle Health Region |
Canada,
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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