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Impact of Uterotonic Agents on Isolated Human Myometrium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00989027
Recruitment Status : Completed
First Posted : October 2, 2009
Last Update Posted : February 20, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Postpartum Hemorrhage Drug: Oxytocin Drug: Ergonovine Drug: Carboprost Drug: Oxytocin and Ergonovine Drug: Oxytocin and Carboprost

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Uterotonic Agents on Isolated Human Myometrium
Study Start Date : June 2007
Primary Completion Date : August 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
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


Outcome Measures

Primary Outcome Measures :
  1. Amplitude of contraction [ Time Frame: 6-8 hours ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00989027     History of Changes
Other Study ID Numbers: 07-08
First Posted: October 2, 2009    Key Record Dates
Last Update Posted: February 20, 2014
Last Verified: February 2014

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
Oxytocin
Ergonovine
Carboprost tromethamine
Carboprost
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents