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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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12 December 2020 |
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Main ID: |
NCT02221531 |
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Date of registration:
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19/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Carbetocin Trial: Carbetocin Appropriate Rate Better Equilibrium Between Tonus (TOnus) and CIrculatioN
CARBETOCIN |
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Scientific title:
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Double-blind Randomised Non-inferiority Trial to Assess Efficacy and Safety of Carbetocin After Caesarean Section Applied as Iv-bolus as Compared to a Short-infusion |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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140 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02221531 |
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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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Switzerland
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Contacts
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Name:
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Salome Dell-Kuster, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Anaesthesiology, University Hospital Basel, Switzerland |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- healthy women
- singleton pregnancy
- caesarean section under regional anaesthesia
- older than 18 years
- written informed consent
Exclusion Criteria:
- emergency caesarean section
- secondary caesarean section due to fetal distress
- comorbidities (cardiovascular, kidney or liver disorder, epilepsy)
- obstetric diseases (hypertension, (pre-)eclampsia)
- uterine malformation (including uterine fibroids)
- bleeding disorder
- known hypersensitivity to carbetocin or oxytocin
- fetal malformation
Age minimum:
18 Years
Age maximum:
46 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Complications; Cesarean Section
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Anesthesia; Reaction
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Intervention(s)
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Drug: Carbetocin Short-infusion
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Drug: Carbetocin Bolus application
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Primary Outcome(s)
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Maximal uterine tone
[Time Frame: within the first 5 minutes after cord clamping]
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Secondary Outcome(s)
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Mean arterial pressure
[Time Frame: within first five minutes after cord clamping]
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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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