- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01962831
Randomized Controlled Trial: Induction of Labour of Obese Women With Dinoprostone or Single Balloon Catheter
October 12, 2016 updated by: Dr. Christine Lett, Saskatchewan Health Authority - Regina Area
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Saskatchewan
-
Regina, Saskatchewan, Canada, S4P0W5
- Regina Qu'Appelle Health Region
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
Other Names:
|
Experimental: Single balloon foley catheter
Group of women that will have a single balloon foley catheter inserted for induction of labour
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time(hours) from initiation of induction of labour to vaginal delivery
Time Frame: Will be assessed at the end of each vaginal delivery
|
Will be assessed at the end of each vaginal delivery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of vaginal deliveries within 24 hours in each group
Time Frame: 2 years
|
2 years
|
Number of cesarean sections in each group
Time Frame: 2 years
|
2 years
|
Number of operative vaginal deliveries in each group
Time Frame: 2 years
|
2 years
|
Number of chorioamnionitis cases in each group
Time Frame: 2 years
|
2 years
|
Number of patients that required oxytocin administration in each group
Time Frame: 2 years
|
2 years
|
Number of patients that required an epidural in each group
Time Frame: 2 years
|
2 years
|
Number of babies that required neonatal intensive care unit (NICU) admission in each group
Time Frame: 2 years
|
2 years
|
Number of babies that had an arterial pH <7 in each group
Time Frame: 2 years
|
2 years
|
Number of babies that had an APGAR score <7 at 5 minutes
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christine Lett, MD, Saskatchewan Health Authority - Regina Area
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
September 19, 2013
First Submitted That Met QC Criteria
October 10, 2013
First Posted (Estimate)
October 14, 2013
Study Record Updates
Last Update Posted (Estimate)
October 13, 2016
Last Update Submitted That Met QC Criteria
October 12, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB-13-51
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Dinoprostone
-
Cairo UniversityCompletedDinoprostone TimingEgypt
-
Seoul National University HospitalCompletedNulliparous Women Who Scheduled for Labor InductionKorea, Republic of
-
Università degli Studi di BresciaCompletedLabor, Induced | Cervical RipeningItaly
-
Intermountain Health Care, Inc.Ferring PharmaceuticalsTerminatedInduction of Labor Affected Fetus / NewbornUnited States
-
Hospital Universitario 12 de OctubreInstituto de Salud Carlos III; Spanish Clinical Research Network - SCReNRecruitingFetal Growth RetardationSpain
-
Mednax Center for Research, Education, Quality...Completed
-
Weill Medical College of Cornell UniversityCompletedCervical Ripening | Labor InductionUnited States
-
Zeynep Kamil Maternity and Pediatric Research and...CompletedEarly Amniotomy, Unfavorable CervixTurkey
-
Cairo UniversityCompletedIntrauterine DeviceEgypt
-
Clinical Hospital MerkurCompletedInduction of Labor Affected Fetus / Newborn | Prostaglandins Causing Adverse Effects in Therapeutic UseCroatia