In Vitro Myometrial Contractions in Laboring and Non-laboring Women
NCT ID: NCT01689311
Last Updated: 2012-09-21
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
53 participants
INTERVENTIONAL
2009-03-31
2012-08-31
Brief Summary
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The investigators will be testing isolated uterine muscle samples to increasing concentrations of these four drugs in three patient populations: non-laboring, laboring without exogenous oxytocin augmentation, and laboring with oxytocin augmentation. Contractile measures will be measured and compared between all groups. The investigators hypothesize that oxytocin alone will have a weaker uterotonic effect in oxytocin-augmented laboring patients, and all four drugs will induce different patterns of contractions.
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 in the laboratory for the ability to contract in response to the uterotonics oxytocin, ergonovine, prostaglandin F2alpha, and misoprostol. We will seek to better understand the effects of these drugs by comparing their contractile capability in isolated uterine tissue.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
All samples will undergo dose response treatment (increasing concentrations) of one of the four uterotonic drugs: oxytocin, ergonovine, prostaglandin F2alpha, or misoprostol.
Oxytocin
Oxytocin, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
Ergonovine
Ergonovine, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
Prostaglandin F2alpha
Prostaglandin F2alpha, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
Misoprostol
Misoprostol, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
Interventions
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Oxytocin
Oxytocin, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
Ergonovine
Ergonovine, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
Prostaglandin F2alpha
Prostaglandin F2alpha, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
Misoprostol
Misoprostol, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients requiring primary or first repeat Cesarean section
* Cesarean section under spinal anesthesia
Exclusion Criteria
* Patient who had previous myometrial surgery or more than one previous Cesarean section
* Patients with placental anomalies
* Patients with multiple pregnancy (twins, etc.)
FEMALE
Yes
Sponsors
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University of Toronto
OTHER
Canadian Anesthesiologists' Society
OTHER
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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References
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Balki M, Erik-Soussi M, Kingdom J, Carvalho JC. Comparative efficacy of uterotonic agents: in vitro contractions in isolated myometrial strips of labouring and non-labouring women. Can J Anaesth. 2014 Sep;61(9):808-18. doi: 10.1007/s12630-014-0190-1. Epub 2014 Jun 7.
Other Identifiers
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09-0053-E
Identifier Type: OTHER
Identifier Source: secondary_id
12-06
Identifier Type: -
Identifier Source: org_study_id