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In Vitro Myometrial Contractions in Laboring and Non-laboring Women

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oxytocin
Ergonovine
Prostaglandin F2alpha
Misoprostol
Sponsored by
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage focused on measuring Uterine contraction, Dose response, Non-laboring, Laboring, Laboring with oxytocin augmentation, Oxytocin, Ergonovine, Prostaglandin F2alpha, Misoprostol

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.)

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

All samples will undergo dose response treatment (increasing concentrations) of one of the four uterotonic drugs: oxytocin, ergonovine, prostaglandin F2alpha, or misoprostol.

Outcomes

Primary Outcome Measures

Amplitude of contraction

Secondary Outcome Measures

Integrated area under response curve (AUC)
Basal tone
Frequency of contraction

Full Information

First Posted
September 17, 2012
Last Updated
September 20, 2012
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Collaborators
University of Toronto, Canadian Anesthesiologists' Society
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1. Study Identification

Unique Protocol Identification Number
NCT01689311
Brief Title
In Vitro Myometrial Contractions in Laboring and Non-laboring Women
Official Title
In Vitro Myometrial Contractions in Laboring and Non-laboring Women: Oxytocin is Superior to Other Uterotonic Agents
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Collaborators
University of Toronto, Canadian Anesthesiologists' Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Uterine contraction, Dose response, Non-laboring, Laboring, Laboring with oxytocin augmentation, Oxytocin, Ergonovine, Prostaglandin F2alpha, Misoprostol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
All samples will undergo dose response treatment (increasing concentrations) of one of the four uterotonic drugs: oxytocin, ergonovine, prostaglandin F2alpha, or misoprostol.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
Oxytocin, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
Intervention Type
Drug
Intervention Name(s)
Ergonovine
Other Intervention Name(s)
Ergot, Ergometrine
Intervention Description
Ergonovine, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
Intervention Type
Drug
Intervention Name(s)
Prostaglandin F2alpha
Intervention Description
Prostaglandin F2alpha, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Synthetic prostaglandin E1
Intervention Description
Misoprostol, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
Primary Outcome Measure Information:
Title
Amplitude of contraction
Time Frame
4-5 hours
Secondary Outcome Measure Information:
Title
Integrated area under response curve (AUC)
Time Frame
4-5 hours
Title
Basal tone
Time Frame
4-5 hours
Title
Frequency of contraction
Time Frame
4-5 hours

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mrinalini Balki, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24906304
Citation
Balki M, Erik-Soussi M, Kingdom J, Carvalho JC. Comparative efficacy of uterotonic agents: in vitro contractions in isolated myometrial strips of labouring and non-labouring women. Can J Anaesth. 2014 Sep;61(9):808-18. doi: 10.1007/s12630-014-0190-1. Epub 2014 Jun 7.
Results Reference
derived

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In Vitro Myometrial Contractions in Laboring and Non-laboring Women

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