Trial · Interventional

CompletedPhase 4Results postedRegistry data

Carbetocin Myocardium Trial 2014 Part 2

Short name CMT2014/2

NCTNCT03899961Other id2014/1210

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 240 participants (actual)
Sponsor: Oslo University Hospital · Other
Design: Randomized · Quadruple masking
Countries: 1 country
Norway
Start: 2 Apr 2019
Primary completion: 1 Mar 2022
Completion: 15 Apr 2022
First posted: 2 Apr 2019
Last update posted: 10 Feb 2026
Conditions: Pregnancy Complications

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20192020202120222023

Ph 4
CMT2014/2
NCT03899961
2 Apr 2019 to 15 Apr 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

OxytocinDrug
CarbetocinDrug

Arms2

Active comparator
Oxytocin
Oxytocin 2.5 U i.v.
Experimental
Carbetocin
Carbetocin 100 µg i.v.

Primary outcomes1

Outcomes the sponsor listed as primary.

Plasma Concentration Troponin I
Time frame · 8 hours
Registry description
Group difference in plasma concentration of Troponin I

Secondary outcomes(3)

Blood Loss
Time frame · 10 hours
Registry description
Blood loss estimated by hemoglobin
Uterine Tone Grade
Time frame · 5 min
Registry description
Peroperative assessment of uterine tone grade 0-10 where 0 is no tonus, 10 is maximal tonus
Side Effects
Time frame · 10 min
Registry description
Perioperative side effects, such as palpitations

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· 8 hours

Plasma Concentration Troponin I

Group	Value (ng/L)
Oxytocin	1.2
Carbetocin	1.2

Secondary and other outcome results(3)

Secondary outcomeMean· 10 hours

Blood Loss

Group	Value (mL)	Spread
Oxytocin	386	369
Carbetocin	361	435

Secondary outcomeMedian· 5 min

Uterine Tone Grade

Group	Value (score on a scale)
Oxytocin	7
Carbetocin	8

Secondary outcomeCount of participants· 10 min

Side Effects

Group	Value (Participants)
Oxytocin	50
Carbetocin	55

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
OxytocinOxytocin 2.5 U i.v. Oxytocin: Oxytocin 2.5 U i.v.	0 / 112	0 / 112	50 / 112
CarbetocinCarbetocin 100 µg i.v. Carbetocin: Carbetocin 100 µg i.v.	0 / 103	0 / 103	55 / 103

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

More studies

2 studies on this page

Indexing hint: Randomized controlled trial · 2025

Effects of Prophylactic Oxytocin or Carbetocin on Troponin Release and Postpartum Haemorrhage at Planned Caesarean Delivery: A Double-Blind Randomised Controlled Trial.

Bekkenes et al. 2025BJOG : an international journal of obstetrics and gynaecologycited by 1

PMID 40772429DOI 10.1111/1471-0528.18312PUB-40772429

Full text at the publisher

Publisher page

Indexing hint: Clinical trial · 2021

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 et al. 2021F1000Researchcited by 2

PMID 34745566PMC8561611DOI 10.12688/f1000research.73112.2PUB-34745566

CC BY

Download PDF

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 50 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Healthy pregnant women age 18 to 50 2. Singleton pregnancy at gestational age 36 weeks or more 3. Able to read and understand Norwegian. 4. 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. Exclusion Criteria: 1. Patients with placenta pathology such as praevia, accreta, pre-eclampsia 2. Patients with bleeding disorders including vonWillebrand disease type I. 3. Known intolerance to one of the two drugs. 4. Patients with prolonged QT-time or other serious cardiac diseases. 5. Liver or kidney failure. 6. Epilepsy. 7. Any medical reason why, in the opinion of the investigator, the patient should not participate.

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