The Clinical Carbetocin Myocardium Trial (CMT)

June 9, 2021 updated by: Leiv Arne Rosseland, Oslo University Hospital
Randomized comparison of different cardiotoxicity of carbetocin and oxytocin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Carbetocin has been in clinical use in EU for some years and the efficacy is documented in several RCTs. Circulatory adverse events leading to death has been reported after intravenous injection of oxytocin. Some studies indicate that oxytocin may lead to dose dependent ischemic ECG changes, prolongation of QT time and liberation of biomarkers of myocardial cell death. Previously we have demonstrated comparable vasodilatory effects of oxytocin and carbetocin. There is no clinical study comparing the specific myocardial effects of oxytocin with carbetocin. It may have great impact on the choice of standard medication if the cardiotoxicity of carbetocin is lower compared with oxytocin. The study of potential cardiotoxicity has to be performed in healthy women. Knowing that millions of laboring women have had uneventful injections of oxytocin and carbetocin after delivery, there is probably no reason to fear long lasting negative effects of either drug. If there are differences in cardiotoxicity, this new information should be taken into consideration when planning delivery in pregnant women with heart disease.

The aims of this study are to compare 0h (before C-section), 4h, 12h, 24h, and 48h plasma concentrations of Troponin I, Troponin T, proBNP, CK, and other relevant myocardial markers in elective healthy C-section patients randomized to oxytocin 2.5 U or carbetocin 100 µg, 1 minute injection immediately after delivery.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

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

  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital, Division of Emergencies and Critical Care

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Healthy pregnant women age 18 to 50
  2. Singleton pregnancy at gestational age 36 weeks or more
  3. Able to read and understand Norwegian.

Exclusion Criteria:

  1. Patients with placenta pathology such as praevia, acreta, pre-eclampsia
  2. Patients with bleeding disorders including vonWillebrand disease type I.
  3. Known intolerance to one of the two drugs.
  4. Patients with prolonged QT-time or other serious cardiac diseases.
  5. Liver or kidney failure.
  6. Epilepsy.
  7. Any medical reason why, in the opinion of the investigator, the patient should not participate

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carbetocin
One minute injection of carbetocin 100 µg after the delivery of the baby
Drug: Carbetocin
Other Names:
  • Pabal
Active Comparator: Oxytocin
One minute injection of oxytocin 2.5 U after the delivery of the baby
Drug: Oxytocin
Other Names:
  • Syntocinon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
P-Troponin I
Time Frame: 48 hours
P-Troponin I group differences
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
P-Biomarkers
Time Frame: 48 hours
P-Biomarkers group differences
48 hours
ECG-changes
Time Frame: 1 hour
Group differences in ECG-changes
1 hour
Blood loss
Time Frame: 48 hours
Calculated estimated blood loss (group differences in Hb change)
48 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 48 hours
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
48 hours
Pain intensity
Time Frame: 48 hours
Group differences in pain intensity (Numeric rating scale 0 - 10) and consumption of PCA Morphine
48 hours

Collaborators and Investigators

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

Sponsor

Oslo University Hospital

Investigators

  • Study Director: Leiv Arne Rosseland, PhD, Dep of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway

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

September 1, 2015

Primary Completion (Actual)

January 28, 2019

Study Completion (Actual)

January 28, 2019

Study Registration Dates

First Submitted

August 14, 2015

First Submitted That Met QC Criteria

August 17, 2015

First Posted (Estimate)

August 19, 2015

Study Record Updates

Last Update Posted (Actual)

June 14, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CarbeteocinHeart2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participant data will be analyzed in the Research Group only

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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