Cardiovascular Effects of Carbetocin Given During Elective Cesarean

Pregnancy Clinical Trial

Official title:

Cardiovascular Effects of Carbetocin During Elective Caesarean Delivery: A Randomized Controlled Trial Comparing Infusion Versus Bolus Administration Using Nexfin™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636816
• Other study ID #: H15-03007
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2015
• Last updated: November 15, 2016
• Start date: March 2016
• Est. completion date: June 2016

Study information

• Verified date: November 2016
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators are investigating whether slow administration of carbetocin is tolerated by patients better than if it is administered quickly, with respect to side effects such as headache, nausea, vomiting and facial flushing.

Description:

Patients undergoing elective cesarean under spinal are included in the study. These patients are treated with carbetocin to reduce blood loss from the lining of the womb after delivery of the baby. The study is a randomised double blind controlled trial with 2 groups. One group will receive carbetocin quickly, the second group will receive carbetocin slowly. The investigators will compare the difference between groups with respect to side effects and the effect of carbetocin on the cardiovascular system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• elective cesarean delivery under spinal,

• low risk for post partum hemorrhage,

• able to understand english

Exclusion Criteria:

• cesarean under general anesthesia,

• bleeding condition,

• placenta previa,

• unable to understand english

Related Conditions & MeSH terms

• Effect of Carbetocin on Cardiovascular System
• Pregnancy

Intervention

Drug:
• carbetocin
drug used to increase the tone of uterine muscle to prevent post partum hemorrhage after cesarean delivery.

Locations

Country	Name	City	State
Canada	BC Women's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Edwards Lifesciences

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent change in cardiac output parameters as measured by non-invasive cardiac output monitor	the parameters will be presented as percentage change from the baseline, which is determined prior to the start of the study period	10 minutes
Secondary	incidence of side effects occurring within timeframe below	headache, nausea, vomiting, facial flushing	30 minutes