In Vitro Myometrial Contractions in Laboring and Non-laboring Women

September 20, 2012 updated by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

In Vitro Myometrial Contractions in Laboring and Non-laboring Women: Oxytocin is Superior to Other Uterotonic Agents

The purpose of this study is to compare the ability of an isolated sample of uterine muscle tissue (in a tissue bath) to contract in the presence of various drugs. The drugs studied--uterotonics--are typically used to contract the uterus when a pregnant patient continues to bleed after delivery. Amongst common uterotonic drugs, namely oxytocin, ergonovine, prostaglandin F2alpha, and misoprostol, the most effective one to use is unknown.

The investigators will be testing isolated uterine muscle samples to increasing concentrations of these four drugs in three patient populations: non-laboring, laboring without exogenous oxytocin augmentation, and laboring with oxytocin augmentation. Contractile measures will be measured and compared between all groups. The investigators hypothesize that oxytocin alone will have a weaker uterotonic effect in oxytocin-augmented laboring patients, and all four drugs will induce different patterns of contractions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 in the laboratory for the ability to contract in response to the uterotonics oxytocin, ergonovine, prostaglandin F2alpha, and misoprostol. We will seek to better understand the effects of these drugs by comparing their contractile capability in isolated uterine tissue.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Gestational age 37-41 weeks
  • Patients requiring primary or first repeat Cesarean section
  • Cesarean section under spinal anesthesia

Exclusion Criteria:

  • Patients who require general anesthesia
  • Patient who had previous myometrial surgery or more than one previous Cesarean section
  • Patients with placental anomalies
  • Patients with multiple pregnancy (twins, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
All samples will undergo dose response treatment (increasing concentrations) of one of the four uterotonic drugs: oxytocin, ergonovine, prostaglandin F2alpha, or misoprostol.
Drug: Oxytocin
Oxytocin, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
Other Names:
  • Pitocin
Drug: Ergonovine
Ergonovine, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
Other Names:
  • Ergot
  • Ergometrine
Drug: Prostaglandin F2alpha
Prostaglandin F2alpha, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
Drug: Misoprostol
Misoprostol, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
Other Names:
  • Synthetic prostaglandin E1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amplitude of contraction
Time Frame: 4-5 hours
4-5 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Integrated area under response curve (AUC)
Time Frame: 4-5 hours
4-5 hours
Basal tone
Time Frame: 4-5 hours
4-5 hours
Frequency of contraction
Time Frame: 4-5 hours
4-5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Collaborators

University of Toronto
Canadian Anesthesiologists' Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

September 20, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Estimate)

September 21, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-06
  • 09-0053-E (Other Identifier: REB (MSH))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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