The Clinical Carbetocin Myocardium Trial (CMT)
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|ClinicalTrials.gov Identifier: NCT02528136|
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : June 14, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Drug: Carbetocin Drug: Oxytocin||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
One minute injection of carbetocin 100 µg after the delivery of the baby
Other Name: Pabal
Active Comparator: Oxytocin
One minute injection of oxytocin 2.5 U after the delivery of the baby
Other Name: Syntocinon
- P-Troponin I [ Time Frame: 48 hours ]P-Troponin I group differences
- P-Biomarkers [ Time Frame: 48 hours ]P-Biomarkers group differences
- ECG-changes [ Time Frame: 1 hour ]Group differences in ECG-changes
- Blood loss [ Time Frame: 48 hours ]Calculated estimated blood loss (group differences in Hb change)
- Adverse events [ Time Frame: 48 hours ]Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
- Pain intensity [ Time Frame: 48 hours ]Group differences in pain intensity (Numeric rating scale 0 - 10) and consumption of PCA Morphine
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|Ages Eligible for Study:||18 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Healthy pregnant women age 18 to 50
- Singleton pregnancy at gestational age 36 weeks or more
- Able to read and understand Norwegian.
- 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.
- Any medical reason why, in the opinion of the investigator, the patient should not participate
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
|Oslo University Hospital, Division of Emergencies and Critical Care|
|Oslo, Norway, 0424|
|Study Director:||Leiv Arne Rosseland, PhD||Dep of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway|
Documents provided by Leiv Arne Rosseland, Oslo University Hospital:
|Responsible Party:||Leiv Arne Rosseland, Head for R&D department, Oslo University Hospital|
|Other Study ID Numbers:||
|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|
Reproductive Control Agents
Physiological Effects of Drugs