The Clinical Carbetocin Myocardium Trial

Pregnancy Clinical Trial

— CMT  

Official title:

The Clinical Carbetocin Myocardium Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528136
• Other study ID #: CarbeteocinHeart2014
• Status: Completed
• Phase: Phase 4
• Start date: September 2015
• Est. completion date: January 28, 2019

Study information

• Verified date: June 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized comparison of different cardiotoxicity of carbetocin and oxytocin.

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 we 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.

The aims of this study are to compare 0h (before C-section), 4h, 12h, 24h, and 48h plasma concentrations of Troponin I, Troponin T, proBNP, CK, and other relevant myocardial markers in elective healthy C-section patients randomized to oxytocin 2.5 U or carbetocin 100 µg, 1 minute injection immediately after delivery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 28, 2019
• Est. primary completion date: January 28, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Exclusion Criteria:

1. Patients with placenta pathology such as praevia, acreta, 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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• Carbetocin

• Oxytocin

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Division of Emergencies and Critical Care	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0	48 hours
Other	Pain intensity	Group differences in pain intensity (Numeric rating scale 0 - 10) and consumption of PCA Morphine	48 hours
Primary	P-Troponin I	P-Troponin I group differences	48 hours
Secondary	P-Biomarkers	P-Biomarkers group differences	48 hours
Secondary	ECG-changes	Group differences in ECG-changes	1 hour
Secondary	Blood loss	Calculated estimated blood loss (group differences in Hb change)	48 hours