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

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ClinicalTrials.gov Identifier: NCT01962831
Recruitment Status : Completed
First Posted : October 14, 2013
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Christine Lett, Saskatchewan Health Authority - Regina Area

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : October 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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 Name: 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



Primary Outcome Measures :
  1. Time(hours) from initiation of induction of labour to vaginal delivery [ Time Frame: Will be assessed at the end of each vaginal delivery ]

Secondary Outcome Measures :
  1. Number of vaginal deliveries within 24 hours in each group [ Time Frame: 2 years ]
  2. Number of cesarean sections in each group [ Time Frame: 2 years ]
  3. Number of operative vaginal deliveries in each group [ Time Frame: 2 years ]
  4. Number of chorioamnionitis cases in each group [ Time Frame: 2 years ]
  5. Number of patients that required oxytocin administration in each group [ Time Frame: 2 years ]
  6. Number of patients that required an epidural in each group [ Time Frame: 2 years ]
  7. Number of babies that required neonatal intensive care unit (NICU) admission in each group [ Time Frame: 2 years ]
  8. Number of babies that had an arterial pH <7 in each group [ Time Frame: 2 years ]
  9. Number of babies that had an APGAR score <7 at 5 minutes [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962831


Locations
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Canada, Saskatchewan
Regina Qu'Appelle Health Region
Regina, Saskatchewan, Canada, S4P0W5
Sponsors and Collaborators
Saskatchewan Health Authority - Regina Area
Investigators
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Principal Investigator: Christine Lett, MD Saskatchewan Health Authority - Regina Area
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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: October 14, 2013    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016
Keywords provided by Dr. Christine Lett, Saskatchewan Health Authority - Regina Area:
obesity
labor, induced
pregnancy
cervical ripening
dinoprostone
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Dinoprostone
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs