Carbetocin Myocardium Trial 2014 Part 2

NCT03899961 | Completed Phase 4 Results DMC

• 1 other identifier: 2014/1210
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pregnancy Complications

Keywords

cesarean delivery; blood loss; troponin

Outcome Measures

Primary Outcomes (1)

• Plasma Concentration Troponin I

  Group difference in plasma concentration of Troponin I

  8 hours

Secondary Outcomes (3)

• Blood Loss

  10 hours

• Uterine Tone Grade

  5 min

• Side Effects

  10 min

Study Arms (2)

Oxytocin

ACTIVE COMPARATOR

Oxytocin 2.5 U i.v.

Drug: Oxytocin

Carbetocin

EXPERIMENTAL

Carbetocin 100 µg i.v.

Drug: Carbetocin

Interventions

Carbetocin DRUG

Carbetocin 100 µg i.v.

Carbetocin

Oxytocin DRUG

Oxytocin 2.5 U i.v.

Oxytocin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• University Hospital, Akershus: collaborator

Study Sites (2)

Akershus University Hospital

Lørenskog, Norway

Location

Division of Anaesthesia and Intensive Care Medicine, Oslo University Hospital - Rikshospitalet

Oslo, 0027, Norway

Location

Related Publications (2)

• 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.

  PMID: 40772429 DERIVED

• Bekkenes 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.

  PMID: 34745566 DERIVED

MeSH Terms

Conditions

Pregnancy Complications; Hemorrhage

Interventions

Oxytocin; carbetocin

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Leiv Arne Rosseland
• Organization: Oslo University Hospital

lrossela@ous-hf.no

92204274

Study Officials

• Kristin Sem-Thagaard, MD

  Oslo Universitetssykehus

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor PhD MD

Model Details: The study is a parallel, randomized, blinded phase 4 study (safety)

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: April 2, 2019
• Study Start: April 2, 2019
• Primary Completion: March 1, 2022
• Study Completion: April 15, 2022
• Last Updated: February 10, 2026
• Results First Posted: March 25, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)