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Comparison of Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin in Women Undergoing Elective Caesarean Section: A Double-blinded Randomised Clinical Trial
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.
Details
| Lead sponsor | Universiti Kebangsaan Malaysia Medical Centre |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 50 |
| Start date | 2012-01 |
| Completion | 2014-01 |
Conditions
- Pregnancy Related
- Anaesthesia
Interventions
- Carbetocin
- Oxytocin
Primary outcomes
- Haemodynamic effects — 2 years
1. Haemodynamic effect (blood pressure, heart rate, saturation of oxygen) 2. Presence of ECG changes such as ST depression and changes in T-waves 3. Presence of myocardial ischemia symptoms (such as chest pain, shortness of breath, feeling of heaviness in chest pain) 4. To compare the troponin T levels
Countries
Malaysia