Impact of Uterotonic Agents on Isolated Human Myometrium

NCT ID: NCT00989027

Last Updated: 2014-02-20

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2013-08-31

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.

Conditions

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Postpartum Hemorrhage

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No treatment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment

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

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Oxytocin, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.

Ergonovine

Intervention Type DRUG

Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.

Carboprost

Intervention Type DRUG

Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.

Oxytocin and Ergonovine

Intervention Type DRUG

Oxytocin and Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.

Oxytocin and Carboprost

Intervention Type DRUG

Oxytocin and Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.

Interventions

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Oxytocin

Oxytocin, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.

Intervention Type DRUG

Ergonovine

Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.

Intervention Type DRUG

Carboprost

Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.

Intervention Type DRUG

Oxytocin and Ergonovine

Oxytocin and Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.

Intervention Type DRUG

Oxytocin and Carboprost

Oxytocin and Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.

Intervention Type DRUG

Other Intervention Names

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Ergonovine Maleate Hemabate Oxytocin Ergonovine Oxytocin Hemabate

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Canada

Other Identifiers

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07-08

Identifier Type: -

Identifier Source: org_study_id

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