Impact of Uterotonic Agents on Isolated Human Myometrium

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT00989027
First received: July 29, 2009
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Postpartum Hemorrhage
Drug: Oxytocin
Drug: Ergonovine
Drug: Carboprost
Drug: Oxytocin and Ergonovine
Drug: Oxytocin and Carboprost

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Uterotonic Agents on Isolated Human Myometrium

Resource links provided by NLM:


Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • Amplitude of contraction [ Time Frame: 6-8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Integrated area under response curve (AUC) [ Time Frame: 6-8 hours ] [ Designated as safety issue: No ]
  • Basal tone [ Time Frame: 6-8 hours ] [ Designated as safety issue: No ]
  • Frequency of contraction [ Time Frame: 6-8 hours ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: June 2007
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No treatment
A control sample from each patient (no uterotonic drug applied) will be measured concurrently with samples treated with various drugs.
Active Comparator: Treatment
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
Oxytocin, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Other Name: Oxytocin
Drug: Ergonovine
Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Other Name: Ergonovine Maleate
Drug: Carboprost
Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Other Name: Hemabate
Drug: Oxytocin and Ergonovine
Oxytocin and Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Other Names:
  • Oxytocin
  • Ergonovine
Drug: Oxytocin and Carboprost
Oxytocin and Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Other Names:
  • Oxytocin
  • Hemabate

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989027

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Mrinalini Balki, MD Mount Sinai Hospital, New York
  More Information

No publications provided

Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00989027     History of Changes
Other Study ID Numbers: 07-08
Study First Received: July 29, 2009
Last Updated: February 19, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Uterine contraction
Dose-response
Oxytocin pre-treatment

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Carboprost
Carboprost tromethamine
Ergonovine
Oxytocin
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Oxytocics

ClinicalTrials.gov processed this record on August 26, 2014