PregnancyPhase 4CMTNCT02528136
The Clinical Carbetocin Myocardium Trial
A Phase 4 study testing Carbetocin and Oxytocin in people with Pregnancy, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Randomized comparison of different cardiotoxicity of carbetocin and oxytocin. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Carbetocin and Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2015to 28 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy pregnant women age 18 to 50
- Singleton pregnancy at gestational age 36 weeks or more
- Able to read and understand Norwegian.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital, Division of Emergencies and Critical Care
Oslo, 0424
About this study
Randomized comparison of different cardiotoxicity of carbetocin and oxytocin.
Read the detailed description
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbetocinDrug
Also called Pabal
OxytocinDrug
Also called Syntocinon
| Study group | Role | What they receive |
|---|---|---|
| Carbetocin | Experimental | One minute injection of carbetocin 100 µg after the delivery of the baby Receives: Drug: Carbetocin |
| Oxytocin | Active comparator | One minute injection of oxytocin 2.5 U after the delivery of the baby Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
P-Troponin I
P-Troponin I group differences
Measured: 48 hours
Secondary outcomes (3)
P-Biomarkers
P-Biomarkers group differences
Measured: 48 hours
ECG-changes
Group differences in ECG-changes
Measured: 1 hour
Blood loss
Calculated estimated blood loss (group differences in Hb change)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startSep 2015
- Primary completion28 Jan 2019
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leiv Arne Rosseland, Oslo University Hospital
- Investigators
- Leiv Arne Rosseland, PhD, Study director, Dep of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528136
- Sponsor's protocol ID
- CarbeteocinHeart2014
- Acronym
- CMT
- Status last verified
- Jun 2021
- First submitted
- 14 Aug 2015
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Participant data will be analyzed in the Research Group only
Publications
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.
PubMed 36239406
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Carbetocin Myocardium Trial
- ClinicalTrials.gov ID
- NCT02528136
- Acronym / sponsor ID
- CMT / CarbeteocinHeart2014
- Conditions
- Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized comparison of different cardiotoxicity of carbetocin and oxytocin.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbetocin | Experimental | Drug: CarbetocinOne minute injection of carbetocin 100 µg after the delivery of the baby |
| Oxytocin | Active comparator | Drug: OxytocinOne minute injection of oxytocin 2.5 U after the delivery of the baby |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy pregnant women age 18 to 50
- Singleton pregnancy at gestational age 36 weeks or more
- Able to read and understand Norwegian.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarbetocinAlso: Pabal | Drug | Carbetocin |
| OxytocinAlso: Syntocinon | Drug | Oxytocin |
Primary outcome
P-Troponin I
Time frame: 48 hours
P-Troponin I group differences
3 secondary outcomes
P-Biomarkers
Time frame: 48 hours
ECG-changes
Time frame: 1 hour
Blood loss
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Derived from this study: PubMed 36239406Bekkenes 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.
- Individual participant dataSharing planned: No. Participant data will be analyzed in the Research Group only
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leiv Arne Rosseland, PhD study director
Dep of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carbetocin and Oxytocin in people with Pregnancy, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P-Troponin I (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02528136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.