NCT01719952

Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin

Comparison of Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin in Women Undergoing Elective Caesarean Section: A Double-blinded Randomised Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Universiti Kebangsaan Malaysia Medical Centre · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

A double-blinded randomised control trial conducted in the Department of Obstetrics and Gynaecology of a tertiary hospital, Universiti Kebangsaan Malaysia Medical Centre (UKMMC) for two years duration from January 1st, 2012 till December 31st, 2013. The aim of the study is to compare the haemodynamic and cardiovascular effects between intravenous carbetocin 100 μg and intravenous oxytocin 5 IU in women undergoing elective Lower Segment Caesarean Section (EL LSCS). Study hypothesis: A single injection of carbetocin is haemodynamically and cardiovascularly safe and has similar efficacy in comparison to a single injection of oxytocin.

Detailed description

OUTCOME MEASURES systolic blood pressure (SBP), diastolic blood pressure (DBP), Heart Rate (HR), saturation of oxygen (SpO2) in certain time after drug injection. The presence of myocardial ischemia symptoms and side effects of both drugs, ECG changes such as ST depression and changes in T-waves. Hemoglobin and troponin-T level The need for additional oxytocin infusion and estimated blood loss The time interval between initial drug administration, type of additional oxytocic intervention that used and complication that happened.

Conditions

• Pregnancy Related
• Anaesthesia

Interventions

Type	Name	Description
DRUG	Carbetocin	IV carbetocin 100mcg, only in selected patient given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group. pitocin 5 IU also given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.
DRUG	Oxytocin	5 IU given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2012-11-01
• Last updated: 2015-02-27

Locations

1 site across 1 country: Malaysia