Impact of Uterotonic Agents on Isolated Human Myometrium
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.
Drug: Oxytocin and Ergonovine
Drug: Oxytocin and Carboprost
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Impact of Uterotonic Agents on Isolated Human Myometrium|
- Amplitude of contraction [ Time Frame: 6-8 hours ] [ Designated as safety issue: No ]
- Integrated area under response curve (AUC) [ Time Frame: 6-8 hours ] [ Designated as safety issue: No ]
- Basal tone [ Time Frame: 6-8 hours ] [ Designated as safety issue: No ]
- Frequency of contraction [ Time Frame: 6-8 hours ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
No Intervention: No treatment
A control sample from each patient (no uterotonic drug applied) will be measured concurrently with samples treated with various drugs.
Active Comparator: 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, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Other Name: OxytocinDrug: Ergonovine
Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Other Name: Ergonovine MaleateDrug: Carboprost
Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Other Name: HemabateDrug: Oxytocin and Ergonovine
Oxytocin and Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Other Names:Drug: Oxytocin and Carboprost
Oxytocin and Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
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.
|Contact: Mrinalini Balki, MD||416-586-4800 ext firstname.lastname@example.org|
|Mount Sinai Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 1X5|
|Contact: Mrinalini Balki, MD 416-586-4800 ext 5270 email@example.com|
|Principal Investigator: Mrinalini Balki, MD|
|Sub-Investigator: Magda Erik-Soussi, MSc|
|Sub-Investigator: John Kingdom, MD|
|Sub-Investigator: Jose CA Carvalho, MD PhD|
|Principal Investigator:||Mrinalini Balki, MD||Mount Sinai Hospital, New York|