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Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin

NCT01719952 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-02-27

No results posted yet for this study

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.

Conditions

  • Pregnancy Related
  • Anaesthesia

Interventions

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.

Sponsors & Collaborators

  • Universiti Kebangsaan Malaysia Medical Centre

    lead OTHER

Principal Investigators

  • Nirmala C Kampan, MRCOG(UK) · Universiti Kebangsaan Malaysia Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-12-31
Completion
2014-01-31

Countries

  • Malaysia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01719952 on ClinicalTrials.gov