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OpenTrials
Completed

NCT Number: NCT02636816

Cardiovascular Effects of Carbetocin Given During Elective Cesarean

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.

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Key information

Conditions

Effect of Carbetocin on Cardiovascular System Pregnancy

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbetocin

Drug

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

Other names: Duratocin

Primary outcomes

  1. percent change in cardiac output parameters as measured by non-invasive cardiac output monitor

    Time frame: 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 outcomes

  1. incidence of side effects occurring within timeframe below

    Time frame: 30 minutes

    headache, nausea, vomiting, facial flushing

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Edwards Lifesciences

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 22, 2015
Registry last updated
Nov 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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