Cardiovascular Effects of Carbetocin Given During Elective Cesarean

University of British Columbia

Status and phase: Completed; Phase 4

Conditions: Effect of Carbetocin on Cardiovascular System; Pregnancy

Treatments: Drug: carbetocin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02636816

H15-03007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: Female

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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57 participants in 2 patient groups

Infusion

Experimental group

Description:

carbetocin is given slowly

Treatment:

Drug: carbetocin

Bolus

Active Comparator group

Description:

carbetocin is given quickly

Treatment:

Drug: carbetocin