Carbetocin Versus Syntocinon for Prevention of Postpartum Hemorrhage in Cardiac Patients Undergoing Caesarean Section

What Was Tested

The trial (phase 4) is built around Carbetocin.

Management of uterine tone after delivery involves giving a prophylactic uterotonic and the use of controlled cord traction to facilitate delivery of the placenta and minimize blood loss.

It had two arms (groups): syntocinon group (active comparator) and carbetocin group (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 38 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Pregnant female single tone \>38 weeks. Age :18-45 years old. Patient with ASA III. Cardiac patients ( mild and moderate mitral stenosis-aortic stenosis valve disease ).

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: other cardiac conditions (valve regurge, cardiomyopathy, heart failure,severe mitral stenosis, severe aortic stenosis, severe pulmonary hypertension); pregnancy hypertensive disorders (eclampsia,preeclampsia); abnormal placental attachment (accrete,percreta,increta).

How the Study Was Run

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

Because people in this Carbetocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Carbetocin was given.

Those kept unaware of assignments: investigator.

It started in 2021-11-30 with completion listed for 2023-06-25.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Cardiac output (time frame: intraoperative).

It also tracked 1 secondary outcome, for example systemic vascular resistance.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Carbetocin in 38 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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