Carbetocin Myocardium Trial 2014 Part 2

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Collaborator: University Hospital, Akershus
• Treatments: Carbetocin; Oxytocin

Criteria

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.