In-vitro Myometrial Contractility After Oxytocin Pre-exposure in Women With Advanced Maternal Age and Morbid Obesity
Primary Purpose
Postpartum Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oxytocin
Sponsored by
About this trial
This is an interventional treatment trial for Postpartum Hemorrhage focused on measuring Uterine contraction, Dose response, Oxytocin
Eligibility Criteria
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
Sites / Locations
- Mount Sinai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Oxytocin
Arm Description
A control sample from each patient (no oxytocin applied) will be measured concurrently with samples treated with varying concentrations of oxytocin.
Samples from each patient will be bathed in a solution containing varying concentrations of oxytocin.
Outcomes
Primary Outcome Measures
Motility index
Secondary Outcome Measures
Amplitude of contraction
Integrated area under response curve (AUC)
Frequency of contraction
Full Information
NCT ID
NCT01865669
First Posted
May 28, 2013
Last Updated
February 5, 2018
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01865669
Brief Title
In-vitro Myometrial Contractility After Oxytocin Pre-exposure in Women With Advanced Maternal Age and Morbid Obesity
Official Title
In-vitro Myometrial Contractility After Oxytocin Pre-exposure in Women With Advanced Maternal Age and Morbid Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 13, 2017 (Actual)
Study Completion Date
June 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
In view of the growing concern over the rising incidence of later maternal age and morbid obesity in the obstetric population, scientific evidence on pregnancy outcomes in these patients is timely and important. The investigators' previously validated in-vitro model provides a solid foundation for the study of myometrial contractility under controlled conditions, without any confounders that could be encountered in clinical settings. It is also likely to provide in-depth understanding of the parameters that the investigators feel are responsible for higher incidence of PPH in these patients. The investigators' study will form a basis for future modifications in oxytocin augmentation regimens and pharmacotherapy for control of PPH in these patient populations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Uterine contraction, Dose response, Oxytocin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
A control sample from each patient (no oxytocin applied) will be measured concurrently with samples treated with varying concentrations of oxytocin.
Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
Samples from each patient will be bathed in a solution containing varying concentrations of oxytocin.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
pitocin
Intervention Description
Oxytocin, 10-10mol/L to 10-5mol/L
Primary Outcome Measure Information:
Title
Motility index
Time Frame
6-8 hours
Secondary Outcome Measure Information:
Title
Amplitude of contraction
Time Frame
6-8 hours
Title
Integrated area under response curve (AUC)
Time Frame
6-8 hours
Title
Frequency of contraction
Time Frame
6-8 hours
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mrinalini Balki, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32189217
Citation
Luca AM, Carvalho JCA, Ramachandran N, Balki M. The effect of morbid obesity or advanced maternal age on oxytocin-induced myometrial contractions: an in vitro study. Can J Anaesth. 2020 Jul;67(7):836-846. doi: 10.1007/s12630-020-01615-6. Epub 2020 Mar 18.
Results Reference
derived
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In-vitro Myometrial Contractility After Oxytocin Pre-exposure in Women With Advanced Maternal Age and Morbid Obesity
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