Impact of Uterotonic Agents on Isolated Human Myometrium

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Uterotonic Agents on Isolated Human Myometrium

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Ergonovine
* Drug: Carboprost
* Drug: Oxytocin and Ergonovine
* Drug: Oxytocin and Carboprost


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No treatment<br>A control sample from each patient (no uterotonic drug applied) will be measured concurrently with samples treated with various drugs. | |
| Active Comparator: Treatment<br>Samples from each patient will be bathed in solutions containing varying concentrations of either oxytocin, carboprost and ergonovine, and contractility will be measured. | Drug: Oxytocin<br>* Oxytocin, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.<br>Drug: Ergonovine<br>* Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.<br>* Other names: Ergonovine Maleate;Drug: Carboprost<br>* Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.<br>* Other names: Hemabate;Drug: Oxytocin and Ergonovine<br>* Oxytocin and Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.<br>* Other names: Ergonovine;Drug: Oxytocin and Carboprost<br>* Oxytocin and Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.<br>* Other names: Hemabate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude of contraction |  | 6-8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Integrated area under response curve (AUC) |  | 6-8 hours | 
| Basal tone |  | 6-8 hours | 
| Frequency of contraction |  | 6-8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine contraction, Dose-response, Oxytocin pre-treatment