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Impact of Uterotonic Agents on Isolated Human Myometrium

Impact of Uterotonic Agents on Isolated Human Myometrium

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00989027
Enrollment
56
Registered
2009-10-02
Start date
2007-06-30
Completion date
2013-08-31
Last updated
2014-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Hemorrhage

Keywords

Uterine contraction, Dose-response, Oxytocin pre-treatment

Brief summary

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

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.

Interventions

DRUGOxytocin

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

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

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

DRUGOxytocin and Ergonovine

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

DRUGOxytocin and Carboprost

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

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Amplitude of contraction6-8 hours

Secondary

MeasureTime frame
Integrated area under response curve (AUC)6-8 hours
Basal tone6-8 hours
Frequency of contraction6-8 hours

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026