Impact of Uterotonic Agents on Isolated Human Myometrium
NCT ID: NCT00989027
Last Updated: 2014-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2007-06-30
2013-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No treatment
A control sample from each patient (no uterotonic drug applied) will be measured concurrently with samples treated with various drugs.
No interventions assigned to this group
Treatment
Samples from each patient will be bathed in solutions containing varying concentrations of either oxytocin, carboprost and ergonovine, and contractility will be measured.
Oxytocin
Oxytocin, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Ergonovine
Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Carboprost
Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Oxytocin and Ergonovine
Oxytocin and Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Oxytocin and Carboprost
Oxytocin and Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Interventions
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Oxytocin
Oxytocin, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Ergonovine
Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Carboprost
Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Oxytocin and Ergonovine
Oxytocin and Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Oxytocin and Carboprost
Oxytocin and Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Non-laboring patients, not exposed to exogenous oxytocin
* Patients requiring primary Cesarean section
* Cesarean section under spinal anesthesia
Exclusion Criteria
* Patient who had previous uterine surgery or Cesarean section
* Patients with placental anomalies
* Emergency Cesarean section in labor
* Patients with bleeding disorders
FEMALE
Yes
Sponsors
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Samuel Lunenfeld Research Institute, Mount Sinai Hospital
OTHER
Responsible Party
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Principal Investigators
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Mrinalini Balki, MD
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Locations
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Mount Sinai Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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07-08
Identifier Type: -
Identifier Source: org_study_id
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