- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01865669
In-vitro Myometrial Contractility After Oxytocin Pre-exposure in Women With Advanced Maternal Age and Morbid Obesity
Women with advanced maternal age and morbid obesity, have a higher incidence of labor induction/ augmentation and cesarean section (CS), and are at a greater risk for postpartum hemorrhage (PPH). Oxytocin is the first line drug in the treatment of PPH, however, oxytocin receptor (OTR) desensitization has been recognized in the context of prolonged labors secondary to either endogenous or exogenous oxytocin exposure. It is unknown if oxytocin desensitization specifically affects contractility in women with advanced maternal age and morbid obesity when compared to younger or normal weight populations. Further it is not known if the higher incidence of PPH seen in these women is due to poor uterine contractility and/or poor response to oxytocin.
The investigators hypothesize that women with advanced maternal age and morbid obesity will exhibit poor myometrial contractility as compared to women that are younger and of normal body habitus, in both oxytocin pre-treated and untreated myometrium.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M5G1X5
- Mount Sinai Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients who give written informed consent
- patients requiring elective primary or 1st repeat Cesarean section
- patients with gestational age 37-41 weeks
- non-labouring patients, not exposed to exogenous oxytocin
- Cesarean section under spinal anesthetic
- patients <30 years of age with a normal pre-pregnancy BMI (20 and 24.9 kg/m2)
- patients ≥40 years of age with a normal pre-pregnancy BMI
- patients with a BMI≥40 kg/m2 and age <30 years
Exclusion Criteria:
- patients who refuse to give written informed consent
- patients who require general anesthesia
- patients who have had more than one previous uterine surgery/CS
- patients with placental abnormalities (abruption, accreta, percreta)
- patients with bleeding disorders
- presence of any other risk factors for PPH
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
A control sample from each patient (no oxytocin applied) will be measured concurrently with samples treated with varying concentrations of oxytocin.
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Experimental: Oxytocin
Samples from each patient will be bathed in a solution containing varying concentrations of oxytocin.
|
Oxytocin, 10-10mol/L to 10-5mol/L
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Motility index
Time Frame: 6-8 hours
|
6-8 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Amplitude of contraction
Time Frame: 6-8 hours
|
6-8 hours
|
Integrated area under response curve (AUC)
Time Frame: 6-8 hours
|
6-8 hours
|
Frequency of contraction
Time Frame: 6-8 hours
|
6-8 hours
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Pregnancy Complications
- Obstetric Labor Complications
- Puerperal Disorders
- Obesity
- Uterine Hemorrhage
- Hemorrhage
- Obesity, Morbid
- Postpartum Hemorrhage
- Physiological Effects of Drugs
- Reproductive Control Agents
- Oxytocics
- Oxytocin
Other Study ID Numbers
- 13-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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