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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 June 2021 |
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Main ID: |
NCT02528136 |
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Date of registration:
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14/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Clinical Carbetocin Myocardium Trial
CMT |
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Scientific title:
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The Clinical Carbetocin Myocardium Trial |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02528136 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Norway
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Contacts
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Name:
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Leiv Arne Rosseland, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dep of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pregnancy
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Intervention(s)
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Drug: Oxytocin
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Drug: Carbetocin
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Primary Outcome(s)
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P-Troponin I
[Time Frame: 48 hours]
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Secondary Outcome(s)
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P-Biomarkers
[Time Frame: 48 hours]
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Blood loss
[Time Frame: 48 hours]
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ECG-changes
[Time Frame: 1 hour]
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Secondary ID(s)
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CarbeteocinHeart2014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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