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Carbetocin vs. Oxytocin: In-vitro Myometrial Contractions With and Without Oxytocin Pre-treatment

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oxytocin
Carbetocin
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, Oxytocin pretreatment, Oxytocin, Carbetocin

Eligibility Criteria

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

Inclusion Criteria:

  • Gestational age 37-41 weeks
  • Non-laboring patients, not exposed to exogenous oxytocin
  • 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
  • Emergency Cesarean section in labor
  • Patients with multiple pregnancy (twins, etc.)

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

No drug pre-treatment

Drug pre-treatment

Arm Description

A control sample from each patient (no uterotonic drug will be applied during pre-treatment) will be measured concurrently with samples pre-treated with oxytocin. Controls will undergo the same dose response of oxytocin or carbetocin after pre-treatment period as the groups given oxytocin for pre-treatment.

A sample from each patient will be pre-treated with oxytocin 10-5mol/L. These samples will undergo the same dose response of oxytocin or carbetocin after pre-treatment period as the groups given no drug for pre-treatment (controls).

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 17, 2012
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Collaborators
University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01689298
Brief Title
Carbetocin vs. Oxytocin: In-vitro Myometrial Contractions With and Without Oxytocin Pre-treatment
Official Title
Carbetocin vs. Oxytocin: In-vitro Myometrial Contractions With and Without Oxytocin Pre-treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2012 (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

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. Oxytocin is an old standard, but seems to suffer from a desensitization phenomenon. Carbetocin, a similar drug, has recently been suggested to clinicians as a replacement for oxytocin directly after certain types of Cesarean section. The investigators will be testing isolated uterine muscle samples after pre-treatment with oxytocin OR nothing (control) to increasing concentrations of oxytocin OR carbetocin. Contractile measures will be measured and compared between all groups. The investigators hypothesize that oxytocin pre-treatment will reduce contractions in both oxytocin- and carbetocin-induced contractions, and oxytocin and carbetocin 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 and carbetocin. 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, Oxytocin pretreatment, Oxytocin, Carbetocin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No drug pre-treatment
Arm Type
Active Comparator
Arm Description
A control sample from each patient (no uterotonic drug will be applied during pre-treatment) will be measured concurrently with samples pre-treated with oxytocin. Controls will undergo the same dose response of oxytocin or carbetocin after pre-treatment period as the groups given oxytocin for pre-treatment.
Arm Title
Drug pre-treatment
Arm Type
Active Comparator
Arm Description
A sample from each patient will be pre-treated with oxytocin 10-5mol/L. These samples will undergo the same dose response of oxytocin or carbetocin after pre-treatment period as the groups given no drug for pre-treatment (controls).
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)
Carbetocin
Other Intervention Name(s)
Duratocin
Intervention Description
Carbetocin, 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
6-8 hours
Secondary Outcome Measure Information:
Title
Integrated area under response curve (AUC)
Time Frame
6-8 hours
Title
Basal tone
Time Frame
6-8 hours
Title
Frequency of contraction
Time Frame
6-8 hours

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Gestational age 37-41 weeks Non-laboring patients, not exposed to exogenous oxytocin 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 Emergency Cesarean section in labor 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

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Carbetocin vs. Oxytocin: In-vitro Myometrial Contractions With and Without Oxytocin Pre-treatment

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