Impact of Uterotonic Agents on Isolated Human Myometrium
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|ClinicalTrials.gov Identifier: NCT00989027|
Recruitment Status : Completed
First Posted : October 2, 2009
Last Update Posted : February 20, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Hemorrhage||Drug: Oxytocin Drug: Ergonovine Drug: Carboprost Drug: Oxytocin and Ergonovine Drug: Oxytocin and Carboprost||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Uterotonic Agents on Isolated Human Myometrium|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
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.
Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Other Name: Ergonovine Maleate
Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Other Name: Hemabate
Drug: Oxytocin and Ergonovine
Oxytocin and Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Drug: Oxytocin and Carboprost
Oxytocin and Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
- Amplitude of contraction [ Time Frame: 6-8 hours ]
- Integrated area under response curve (AUC) [ Time Frame: 6-8 hours ]
- Basal tone [ Time Frame: 6-8 hours ]
- Frequency of contraction [ Time Frame: 6-8 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00989027
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Principal Investigator:||Mrinalini Balki, MD||Mount Sinai Hospital, New York|