Pregnancy ComplicationsPhase 4CMT2014/2NCT03899961
Carbetocin Myocardium Trial 2014 Part 2
A Phase 4 study testing Oxytocin and Carbetocin in people with Pregnancy Complications, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy Complications
- What is being tested?
- Oxytocin and Carbetocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesNorway
- Study dates
- 2 Apr 2019to 15 Apr 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
- Patients will be recruited from the general population at the birth clinic at Oslo University Hospital or the birth clinic of Akershus University Hospital. Signed informed consent form (ICF) and expected cooperation of the patients for the treatment and follow up will be obtained and documented according to ICH GCP, and national/local regulations.
Who cannot join
- Patients with placenta pathology such as praevia, accreta, 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
2 sites in 1 country.
Norway2 sites
Akershus University Hospital
Lørenskog
Division of Anaesthesia and Intensive Care Medicine, Oslo University Hospital - Rikshospitalet
Oslo, 0027
About this study
Official title: The Clinical Carbetocin Myocardium Trial Part 2
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 the investigators 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.
Read the detailed description
Background -Treatment Caesarean delivery is a commonly performed surgical procedure. Uterus contraction after delivery of the baby is necessary to avoid excessive bleeding.
Background - Therapeutic Information Adequate uterus contraction after delivery of the baby is necessary to avoid excessive bleeding. Prophylactic administration of an oxytocin receptor agonist is first line practice. Intravenous injection of oxytocin has been the standard procedure but serious cardiovascular adverse events have been reported. Lowering the dose or administering the drug as a 5 minute infusion may increase safety. Carbetocin, a synthetic oxytocin receptor agonist, has significantly longer half life and may reduce blood loss compared with oxytocin. The hemodynamic vasodilatory effects are comparable to oxytocin, but potential differences in adverse effects on myocardium are not well described yet.
Pre-Clinical \& Clinical Experience with Carbetocin (IMP) and Oxytocin Carbetocin has been in clinical use in EU for some years and the efficacy is documented in several RCTs. In the proposed study, carbetocin will be used within the conditions of the marketing authorization. Oxytocin is the first line treatment and prophylaxis in Norway and most countries in the world. According to recently published guidelines from EU drug authorities (EMA), oxytocin should be given as a slow, 5-minute infusion in order to avoid hypotension. This has so far not been implemented in Norway. The pre-clinical and clinical experience of the two drugs are summarized in the Summaries of Product Characteristics.
Rationale for the Study Pregnancy and delivery is a natural process, but for many women this period is stressful and not without risks of morbidity, and even mortality. 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 the investigators 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.
STUDY OBJECTIVES The aims of this study are to compare 0h (before C-section) plasma concentrations of Troponin I (high sensitive methods) with a second measurement of plasma concentration of Troponin I drawn within an interval of 6 to 10 hours after administration of study drug, in elective healthy C-section patients randomized to oxytocin 2.5 U or carbetocin 100 µg, 1 minute injection immediately after delivery.
Primary Endpoint Primary outcome measure is the difference in plasma concentration of Troponin I from baseline (0h) to the second measurement 6-10 hours after test drug administration, according to treatment allocation. Plasma concentrations will be collected before C-section, and at an interval of 6-10 h after test drug administration.
Secondary Endpoints
- Other myocardial biomarkers
- Uterus tone evaluated repeatedly
- Blood loss (estimated calculated blood loss)
- Postoperative pain and side effects.
- BP, heart rate and ECG changes
- Conditions
- Pregnancy Complications
- Being tested
- Oxytocin, Carbetocin
- Keywords
- cesarean delivery, blood loss, troponin
- Medical subject headings
- Pregnancy Complications, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Oxytocin 2.5 U i.v.
CarbetocinDrug
Carbetocin 100 µg i.v.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Active comparator | Oxytocin 2.5 U i.v. Receives: Drug: Oxytocin |
| Carbetocin | Experimental | Carbetocin 100 µg i.v. Receives: Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentration Troponin I
Group difference in plasma concentration of Troponin I
Measured: 8 hours
Secondary outcomes (3)
Blood Loss
Blood loss estimated by hemoglobin
Measured: 10 hours
Uterine Tone Grade
Peroperative assessment of uterine tone grade 0-10 where 0 is no tonus, 10 is maximal tonus
Measured: 5 min
Side Effects
Perioperative side effects, such as palpitations
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start2 Apr 2019
- Primary completion1 Mar 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a parallel, randomized, blinded phase 4 study (safety)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Akershus
- Responsible party
- Principal investigator, Leiv Arne Rosseland, Oslo University Hospital
- Investigators
- Kristin Sem-Thagaard, MD, Study director, Oslo Universitetssykehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899961
- Sponsor's protocol ID
- 2014/1210
- Acronym
- CMT2014/2
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2019
- Last updated
- 10 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bekkenes ME, Jorgensen MM, Jacobsen AF, Fagerland MW, Rakstad-Larsen H, Aaberge L, Klingenberg O, Steinsvik T, Asphaug L, Rosseland LA. Effects of Prophylactic Oxytocin or Carbetocin on Troponin Release and Postpartum Haemorrhage at Planned Caesarean Delivery: A Double-Blind Randomised Controlled Trial. BJOG. 2025 Nov;132(12):1742-1752. doi: 10.1111/1471-0528.18312. Epub 2025 Aug 7.
PubMed 40772429Bekkenes M, Jorgensen MM, Flem Jacobsen A, Wang Fagerland M, Rakstad-Larsen H, Solberg OG, Aaberge L, Klingenberg O, Steinsvik T, Rosseland LA. A study protocol for the cardiac effects of a single dose of either oxytocin 2.5 IU or carbetocin 100 microg after caesarean delivery: a prospective randomized controlled multi-centre trial in Norway. F1000Res. 2021 Sep 27;10:973. doi: 10.12688/f1000research.73112.2. eCollection 2021.
PubMed 34745566
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Carbetocin Myocardium Trial Part 2
- ClinicalTrials.gov ID
- NCT03899961
- Acronym / sponsor ID
- CMT2014/2 / 2014/1210
- Conditions
- Pregnancy Complications
- Keywords
- cesarean delivery, blood loss, troponin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Akershus
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Posted 25 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 the investigators 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.
Detailed description
Background -Treatment Caesarean delivery is a commonly performed surgical procedure. Uterus contraction after delivery of the baby is necessary to avoid excessive bleeding.
Background - Therapeutic Information Adequate uterus contraction after delivery of the baby is necessary to avoid excessive bleeding. Prophylactic administration of an oxytocin receptor agonist is first line practice. Intravenous injection of oxytocin has been the standard procedure but serious cardiovascular adverse events have been reported. Lowering the dose or administering the drug as a 5 minute infusion may increase safety. Carbetocin, a synthetic oxytocin receptor agonist, has significantly longer half life and may reduce blood loss compared with oxytocin. The hemodynamic vasodilatory effects are comparable to oxytocin, but potential differences in adverse effects on myocardium are not well described yet.
Pre-Clinical \& Clinical Experience with Carbetocin (IMP) and Oxytocin Carbetocin has been in clinical use in EU for some years and the efficacy is documented in several RCTs. In the proposed study, carbetocin will be used within the conditions of the marketing authorization. Oxytocin is the first line treatment and prophylaxis in Norway and most countries in the world. According to recently published guidelines from EU drug authorities (EMA), oxytocin should be given as a slow, 5-minute infusion in order to avoid hypotension. This has so far not been implemented in Norway. The pre-clinical and clinical experience of the two drugs are summarized in the Summaries of Product Characteristics.
Rationale for the Study Pregnancy and delivery is a natural process, but for many women this period is stressful and not without risks of morbidity, and even mortality. 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 the investigators 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.
STUDY OBJECTIVES The aims of this study are to compare 0h (before C-section) plasma concentrations of Troponin I (high sensitive methods) with a second measurement of plasma concentration of Troponin I drawn within an interval of 6 to 10 hours after administration of study drug, in elective healthy C-section patients randomized to oxytocin 2.5 U or carbetocin 100 µg, 1 minute injection immediately after delivery.
Primary Endpoint Primary outcome measure is the difference in plasma concentration of Troponin I from baseline (0h) to the second measurement 6-10 hours after test drug administration, according to treatment allocation. Plasma concentrations will be collected before C-section, and at an interval of 6-10 h after test drug administration.
Secondary Endpoints
- Other myocardial biomarkers
- Uterus tone evaluated repeatedly
- Blood loss (estimated calculated blood loss)
- Postoperative pain and side effects.
- BP, heart rate and ECG changes
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a parallel, randomized, blinded phase 4 study (safety)
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Active comparator | Drug: OxytocinOxytocin 2.5 U i.v. |
| Carbetocin | Experimental | Drug: CarbetocinCarbetocin 100 µg i.v. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy pregnant women age 18 to 50
- Singleton pregnancy at gestational age 36 weeks or more
- Able to read and understand Norwegian.
- Patients will be recruited from the general population at the birth clinic at Oslo University Hospital or the birth clinic of Akershus University Hospital. Signed informed consent form (ICF) and expected cooperation of the patients for the treatment and follow up will be obtained and documented according to ICH GCP, and national/local regulations.
Key exclusion criteria (7 listed)
- Patients with placenta pathology such as praevia, accreta, 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 |
|---|---|---|
| OxytocinOxytocin 2.5 U i.v. | Drug | Oxytocin |
| CarbetocinCarbetocin 100 µg i.v. | Drug | Carbetocin |
Primary outcome
Plasma Concentration Troponin I
Time frame: 8 hours
Group difference in plasma concentration of Troponin I
3 secondary outcomes
Blood Loss
Time frame: 10 hours
Uterine Tone Grade
Time frame: 5 min
Side Effects
Time frame: 10 min
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40772429Bekkenes ME, Jorgensen MM, Jacobsen AF, Fagerland MW, Rakstad-Larsen H, Aaberge L, Klingenberg O, Steinsvik T, Asphaug L, Rosseland LA. Effects of Prophylactic Oxytocin or Carbetocin on Troponin Release and Postpartum Haemorrhage at Planned Caesarean Delivery: A Double-Blind Randomised Controlled Trial. BJOG. 2025 Nov;132(12):1742-1752. doi: 10.1111/1471-0528.18312. Epub 2025 Aug 7.
- Derived from this study: PubMed 34745566Bekkenes M, Jorgensen MM, Flem Jacobsen A, Wang Fagerland M, Rakstad-Larsen H, Solberg OG, Aaberge L, Klingenberg O, Steinsvik T, Rosseland LA. A study protocol for the cardiac effects of a single dose of either oxytocin 2.5 IU or carbetocin 100 microg after caesarean delivery: a prospective randomized controlled multi-centre trial in Norway. F1000Res. 2021 Sep 27;10:973. doi: 10.12688/f1000research.73112.2. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Kristin Sem-Thagaard, MD study director
Oslo Universitetssykehus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxytocin and Carbetocin in people with Pregnancy Complications, run by Oslo University Hospital at 2 sites 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 4 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 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 25 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Plasma Concentration Troponin I (time frame: 8 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 NCT03899961, which also lists 2 linked publications.
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 10 Feb 2026.