Back to resultsImpact of Uterotonic Agents on Isolated Human Myometrium
Primary Purpose
Postpartum Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oxytocin
Ergonovine
Carboprost
Oxytocin and Ergonovine
Oxytocin and Carboprost
Sponsored by
About this trial
This is an interventional treatment trial for Postpartum Hemorrhage focused on measuring Uterine contraction, Dose-response, Oxytocin pre-treatment
Eligibility Criteria
Inclusion Criteria:
- Gestational age 37-41 weeks
- Non-laboring patients, not exposed to exogenous oxytocin
- Patients requiring primary Cesarean section
- Cesarean section under spinal anesthesia
Exclusion Criteria:
- Patients who require general anesthesia
- Patient who had previous uterine surgery or Cesarean section
- Patients with placental anomalies
- Emergency Cesarean section in labor
- Patients with bleeding disorders
Sites / Locations
- Mount Sinai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
No treatment
Treatment
Arm Description
A control sample from each patient (no uterotonic drug applied) will be measured concurrently with samples treated with various drugs.
Samples from each patient will be bathed in solutions containing varying concentrations of either oxytocin, carboprost and ergonovine, and contractility will be measured.
Outcomes
Primary Outcome Measures
Amplitude of contraction
Secondary Outcome Measures
Integrated area under response curve (AUC)
Basal tone
Frequency of contraction
Full Information
NCT ID
NCT00989027
First Posted
July 29, 2009
Last Updated
February 19, 2014
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00989027
Brief Title
Impact of Uterotonic Agents on Isolated Human Myometrium
Official Title
Impact of Uterotonic Agents on Isolated Human Myometrium
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (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
The purpose of this study is to compare the ability of a sample of uterine muscle tissue to contract in the presence of various drugs. The drugs studied are typically used to contract the uterus when a pregnant patient continues to bleed after delivery. Amongst the uterotonic drugs (used to contract the uterus), namely oxytocin, ergonovine and carboprost, the most effective one to use is not known.
The investigators will be testing uterine muscle samples in the presence of these drugs at various concentrations, to see what their contractility measures over time, as compared with a control sample, in which no drugs will be applied.
Detailed Description
Postpartum hemorrhage (PPH) is a major cause of maternal mortality and morbidity. In 80% cases of PPH, the primary cause is failure of the uterus to contract after delivery of the baby, which then requires further treatment of the mother with uterotonic drugs (drugs used to contract uterus and thus prevent bleeding).
Patients participating in this study will be asked to donate a very small sample of uterine tissue during Cesarean section, which will be tested for the ability to contract after treatment with various uterotonic drugs (oxytocin, ergonovine and carboprost) in the laboratory. This information will help us know the effect of these drugs by comparing the contractile capability of the uterine tissue.
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 pre-treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
A control sample from each patient (no uterotonic drug applied) will be measured concurrently with samples treated with various drugs.
Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
Samples from each patient will be bathed in solutions containing varying concentrations of either oxytocin, carboprost and ergonovine, and contractility will be measured.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
Oxytocin, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Intervention Type
Drug
Intervention Name(s)
Ergonovine
Other Intervention Name(s)
Ergonovine Maleate
Intervention Description
Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Intervention Type
Drug
Intervention Name(s)
Carboprost
Other Intervention Name(s)
Hemabate
Intervention Description
Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Intervention Type
Drug
Intervention Name(s)
Oxytocin and Ergonovine
Other Intervention Name(s)
Oxytocin, Ergonovine
Intervention Description
Oxytocin and Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Intervention Type
Drug
Intervention Name(s)
Oxytocin and Carboprost
Other Intervention Name(s)
Oxytocin, Hemabate
Intervention Description
Oxytocin and Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Primary Outcome Measure Information:
Title
Amplitude of contraction
Time Frame
6-8 hours
Secondary Outcome Measure Information:
Title
Integrated area under response curve (AUC)
Time Frame
6-8 hours
Title
Basal tone
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:
Gestational age 37-41 weeks
Non-laboring patients, not exposed to exogenous oxytocin
Patients requiring primary Cesarean section
Cesarean section under spinal anesthesia
Exclusion Criteria:
Patients who require general anesthesia
Patient who had previous uterine surgery or Cesarean section
Patients with placental anomalies
Emergency Cesarean section in labor
Patients with bleeding disorders
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
M5G 1X5
Country
Canada
12. IPD Sharing Statement
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Impact of Uterotonic Agents on Isolated Human Myometrium
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