Impact of Uterotonic Agents on Isolated Human Myometrium

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status: Completed

Conditions: Postpartum Hemorrhage

Treatments: Drug: Oxytocin and Ergonovine; Drug: Oxytocin; Drug: Ergonovine; Drug: Oxytocin and Carboprost; Drug: Carboprost

Study type: Interventional

Funder types: Other

Identifiers

NCT00989027

07-08

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 56 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

No treatment

No Intervention group

Description:

A control sample from each patient (no uterotonic drug applied) will be measured concurrently with samples treated with various drugs.

Treatment

Active Comparator group

Description:

Samples from each patient will be bathed in solutions containing varying concentrations of either oxytocin, carboprost and ergonovine, and contractility will be measured.

Treatment:

Drug: Carboprost

Drug: Oxytocin and Carboprost

Drug: Ergonovine

Drug: Oxytocin

Drug: Oxytocin and Ergonovine