CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 240 enrolled
Drug / intervention
Oxytocin +1 moredrug
Likely dose
Carbetocin 100 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03899961
NCT03899961Phase 4Completed

The Clinical Carbetocin Myocardium Trial Part 2

Oslo University Hospital·interventional·Posted Apr 2, 2019·Updated Feb 10, 2026

In Brief

A Phase 4 clinical trial evaluating Oxytocin and Carbetocin for Pregnancy Complications. Completed, enrolled 240 participants across 2 sites.

Detailed 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. 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNorway

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedApr 2, 2019
Enrollment StartApr 2, 2019
Primary CompletionMar 1, 2022
Study CompletionApr 15, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 7.3 years ago

Interventions

Oxytocindrug

Oxytocin 2.5 U i.v.

Carbetocindrug

Carbetocin 100 µg i.v.