Pregnancy Related Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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