Cardiovascular Effects of Carbetocin Given During Elective Cesarean

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02636816

Enrollment

Registered

2015-12-22

Start date

2016-03-31

Completion date

2016-06-30

Last updated

2016-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of Carbetocin on Cardiovascular System, Pregnancy

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.

Interventions

DRUGcarbetocin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
incidence of side effects occurring within timeframe below	30 minutes	headache, nausea, vomiting, facial flushing

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026