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The Clinical Carbetocin Myocardium Trial (CMT)

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: NCT02528136
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
Leiv Arne Rosseland, Oslo University Hospital

Study Description
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Brief Summary:
Randomized comparison of different cardiotoxicity of carbetocin and oxytocin.

Condition or disease Intervention/treatment Phase
Pregnancy Drug: Carbetocin Drug: Oxytocin Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Clinical Carbetocin Myocardium Trial
Study Start Date : September 2015
Actual Primary Completion Date : January 28, 2019
Actual Study Completion Date : January 28, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Carbetocin
One minute injection of carbetocin 100 µg after the delivery of the baby
 Drug: Carbetocin
Other Name: Pabal
Active Comparator: Oxytocin
One minute injection of oxytocin 2.5 U after the delivery of the baby
 Drug: Oxytocin
Other Name: Syntocinon


Outcome Measures
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Primary Outcome Measures :
  1. P-Troponin I [ Time Frame: 48 hours ]
    P-Troponin I group differences


Secondary Outcome Measures :
  1. P-Biomarkers [ Time Frame: 48 hours ]
    P-Biomarkers group differences

  2. ECG-changes [ Time Frame: 1 hour ]
    Group differences in ECG-changes

  3. Blood loss [ Time Frame: 48 hours ]
    Calculated estimated blood loss (group differences in Hb change)


Other Outcome Measures:
  1. Adverse events [ Time Frame: 48 hours ]
    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  2. Pain intensity [ Time Frame: 48 hours ]
    Group differences in pain intensity (Numeric rating scale 0 - 10) and consumption of PCA Morphine


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT02528136


Locations
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Norway
Oslo University Hospital, Division of Emergencies and Critical Care
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Study Director: Leiv Arne Rosseland, PhD Dep of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway
  Study Documents (Full-Text)

Documents provided by Leiv Arne Rosseland, Oslo University Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] February 6, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Leiv Arne Rosseland, Head for R&D department, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02528136    
Other Study ID Numbers: CarbeteocinHeart2014
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participant data will be analyzed in the Research Group only
Additional relevant MeSH terms:
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Oxytocin
Carbetocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs