NCT03899961: CMT2014/2

Carbetocin Myocardium Trial 2014 Part 2

Completed Phase 4 Results posted Last updated 10 February 2026

What this trial tests

Phase 4 trial testing Oxytocin in Pregnancy Complications in 240 participants. Completed in 15 April 2022.

Timeline

2 April 2019

Primary endpoint
1 March 2022

15 April 2022

Quick facts

Lead sponsor	Oslo University Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	240
Start date	2 April 2019
Primary completion	1 March 2022
Estimated completion	15 April 2022
Sites	2 locations across Norway

Drugs / interventions tested

• Oxytocin (OXYTOCIN) — full drug profile →
• Carbetocin (CARBETOCIN) — full drug profile →

Conditions studied

• Pregnancy Complications — all drugs for Pregnancy Complications →

Sponsor

Oslo University Hospital

Who can join

Adults 18 to 50, female only, with Pregnancy Complications. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Plasma Concentration Troponin I Primary · 8 hours

Group difference in plasma concentration of Troponin I

Group	Value	95% CI
Oxytocin	1.2	1.0 – 47.0
Carbetocin	1.2	1.0 – 19.5

Blood Loss Secondary · 10 hours

Blood loss estimated by hemoglobin

Group	Value	95% CI
Oxytocin	386	± 369
Carbetocin	361	± 435

Uterine Tone Grade Secondary · 5 min

Peroperative assessment of uterine tone grade 0-10 where 0 is no tonus, 10 is maximal tonus

Group	Value	95% CI
Oxytocin	7	4 – 10
Carbetocin	8	4 – 10

Side Effects Secondary · 10 min

Perioperative side effects, such as palpitations

Group	Value	95% CI
Oxytocin	50
Carbetocin	55

Adverse events — posted to ClinicalTrials.gov

Time frame: 48 h. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Oxytocin

Serious: 0/112 (0%)

Deaths: 0/112

Carbetocin

Serious: 0/103 (0%)

Deaths: 0/103

Other adverse events (8 terms — click to expand)

Reaction	System	Oxytocin	Carbetocin
Feeling hot	General disorders	—	—
dry mouth	Gastrointestinal disorders	—	—
Chest pain	Cardiac disorders	—	—
flushing	Vascular disorders	—	—
nausea	Gastrointestinal disorders	—	—
dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
headache	Nervous system disorders	—	—
palpitations	Cardiac disorders	—	—

Data from ClinicalTrials.gov NCT03899961 adverse events section.

Sponsor's own 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 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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. A study protocol for the cardiac effects of a single dose of either oxytocin 2.5 IU or carbetocin 100 µg after caesarean delivery: a prospective randomized controlled multi-centre trial in Norway.
   Bekkenes M, Jørgensen MM, Flem Jacobsen A, Wang Fagerland M, et al · · 2021 · cited 1× · PMID 34745566 · DOI 10.12688/f1000research.73112.2
2. Effects of Prophylactic Oxytocin or Carbetocin on Troponin Release and Postpartum Haemorrhage at Planned Caesarean Delivery: A Double-Blind Randomised Controlled Trial.
   Bekkenes ME, Jørgensen MM, Jacobsen AF, Fagerland MW, et al · · 2025 · PMID 40772429 · DOI 10.1111/1471-0528.18312
3. A study protocol for the cardiac effects of a single dose of either oxytocin 2.5 IU or carbetocin 100 µg after caesarean delivery: a prospective randomized controlled multi-centre trial in Norway
   Bekkenes M, Jørgensen MM, Flem Jacobsen A, Wang Fagerland M, et al · · 2022 · DOI 10.12688/f1000research.73112.2