Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin

What Was Tested

In this not phased trial, researchers set out to test Oxytocin and Carbetocin.

It had two arms (groups): Carbetocin (experimental) and Oxytocin (active comparator).

Other names are Pitocin, syntocinon 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.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 50 actual participants took part.

It was open to women only aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Viable, singleton pregnancy ≥ 37 weeks gestation undergoing EL LSCS. Ability to provide informed consent.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: emergency caesarean section; preterm labour; multiple pregnancy.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

The Oxytocin group and the comparison group ran side by side rather than switching.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2012-01 with completion listed for 2013-12.

It ran at 1 site in Malaysia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Haemodynamic effects (time frame: 2 years).

It also tracked 1 secondary outcome, for example Blood loss measurement.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin and Carbetocin in 50 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page and the Carbetocin compound page, all human trials.