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OpenTrials
Completed

NCT Number: NCT02528136

The Clinical Carbetocin Myocardium Trial

Randomized comparison of different cardiotoxicity of carbetocin and oxytocin.

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Key information

Conditions

Pregnancy

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Oslo University Hospital, Division of Emergencies and Critical Care

Oslo, 0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Carbetocin

Drug

Other names: Pabal

Oxytocin

Drug

Other names: Syntocinon

Primary outcomes

  1. P-Troponin I

    Time frame: 48 hours

    P-Troponin I group differences

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Acronym: CMT

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 19, 2015
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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