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Completed

NCT Number: NCT00989027

Impact of Uterotonic Agents on Isolated Human Myometrium

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.

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Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

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

Ergonovine

Drug

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

Other names: Ergonovine Maleate

Carboprost

Drug

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

Other names: Hemabate

Oxytocin and Ergonovine

Drug

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

Other names: Oxytocin, Ergonovine

Oxytocin and Carboprost

Drug

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

Other names: Oxytocin, Hemabate

Primary outcomes

  1. Amplitude of contraction

    Time frame: 6-8 hours

Secondary outcomes

  1. Integrated area under response curve (AUC)

    Time frame: 6-8 hours

  2. Basal tone

    Time frame: 6-8 hours

  3. Frequency of contraction

    Time frame: 6-8 hours

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Oct 2, 2009
Registry last updated
Feb 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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