The Clinical Carbetocin Myocardium Trial
CMT
1 other identifier
interventional
40
1 country
1
Brief Summary
Randomized comparison of different cardiotoxicity of carbetocin and oxytocin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 pregnancy
Started Sep 2015
Typical duration for phase_4 pregnancy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2015
CompletedFirst Posted
Study publicly available on registry
August 19, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2019
CompletedJune 14, 2021
June 1, 2021
3.4 years
August 14, 2015
June 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
P-Troponin I
P-Troponin I group differences
48 hours
Secondary Outcomes (3)
P-Biomarkers
48 hours
ECG-changes
1 hour
Blood loss
48 hours
Other Outcomes (2)
Adverse events
48 hours
Pain intensity
48 hours
Study Arms (2)
Carbetocin
EXPERIMENTALOne minute injection of carbetocin 100 µg after the delivery of the baby
Oxytocin
ACTIVE COMPARATOROne minute injection of oxytocin 2.5 U after the delivery of the baby
Interventions
Eligibility Criteria
You may qualify if:
- Healthy pregnant women age 18 to 50
- Singleton pregnancy at gestational age 36 weeks or more
- Able to read and understand Norwegian.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oslo University Hospital, Division of Emergencies and Critical Care
Oslo, 0424, Norway
Related Publications (1)
Bekkenes ME, Fagerland MW, Solberg OG, Aaberge L, Klingenberg O, Norseth J, Rosseland LA. Exploring cardiac effects after oxytocin 2.5 IU or carbetocin 100 mug: A randomised controlled trial in women undergoing planned caesarean delivery. Eur J Anaesthesiol. 2022 Dec 1;39(12):928-938. doi: 10.1097/EJA.0000000000001763. Epub 2022 Oct 17.
PMID: 36239406DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Leiv Arne Rosseland, PhD
Dep of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head for R&D department
Study Record Dates
First Submitted
August 14, 2015
First Posted
August 19, 2015
Study Start
September 1, 2015
Primary Completion
January 28, 2019
Study Completion
January 28, 2019
Last Updated
June 14, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share
Participant data will be analyzed in the Research Group only