Cardiovascular Effects of Carbetocin Given During Elective Cesarean

Phase 4

Completed

• Conditions: Effect of Carbetocin on Cardiovascular System; Pregnancy
• Interventions: Drug: carbetocin

• Registration Number: NCT02636816
• Lead Sponsor: University of British Columbia

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2015-12-21
• Study First Posted: 2015-12-22
• Study Start: 2016-03
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-15
• Last Update Posted: 2016-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infusion	carbetocin	carbetocin is given slowly
Bolus	carbetocin	carbetocin is given quickly

Primary Outcome Measures

Name	Time	Method
percent change in cardiac output parameters as measured by non-invasive cardiac output monitor	10 minutes	the parameters will be presented as percentage change from the baseline, which is determined prior to the start of the study period

Secondary Outcome Measures

Name	Time	Method
incidence of side effects occurring within timeframe below	30 minutes	headache, nausea, vomiting, facial flushing

Trial Locations

Locations (1)

BC Women's Hospital; 🇨🇦 Vancouver, British Columbia, Canada