Efficacy of Four Different Treatment Regimes on Postpartum Hemorrhage

What Was Tested

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

Drugs such as oxytocin, carbetocin and tranexamic acid are used for bleeding control after normal vaginal delivery.

It had four arms (groups): Carbetocin (experimental), Oxytocin Group (experimental), Carbetocin and Tranexamic acid Group (experimental) and Oxytocin and Tranexamic acid Group (experimental).

100-mg carbetocin was intravenously administered immediately after birth of the baby.

The registry classes the interventions as drug.

More on the Plan

Written informed consent was obtained from all patients.

Investigators included a total of 272 women between 18 and 40 years of age who came to hospital for vaginal delivery at term single pregnancy.

This trial was designed and reported according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.

The patients included in this study were randomly divided into four groups by random allocation using a computer-generated random number.

Who Took Part

300 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Single pregnancy greater than 37 weeks. Pregnant women between the ages of 18-40.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: pregnancy less than 37 weeks; patients under stress who cannot give informed consent; patients allergic to carbetocin, oxytocin or tranexamic acid.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

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

In this single-blind Oxytocin study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2022-08-01 with completion listed for 2023-01-25.

It ran at 1 site in Turkey (Türkiye).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Hemogram status (time frame: Postpartum 24th hour).

It also tracked 1 secondary outcome, for example Blood Transfusion.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin and Carbetocin in 300 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.