Randomization of Oxytocin, Oxytocin+Intrauterine Misoprostol and Carbetocin During C-section

What Was Tested

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

Drugs such as oxytocin, carbetocin, misoprostol, prostaglandin F2a and methylergonovine have been tested for bleeding control during and after cesarean section.

It had three arms (groups): Oxytocin Group (experimental), Oxytocin+Intrauterine Misoprostol (experimental) and Carbetocin (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.

The researchers included a total of 156 women between 18 and 40 years of age who underwent a primary cesarean section or old 1 cesarean section under spinal anesthesia at term single pregnancy with an American Society of Anesthesiology physical status of I or II.

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 three groups by random allocation using a computer-generated random number.

Who Took Part

Enrollment: 156 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 Volunteer.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: clinical diagnosis of gestational diabetes; clinical diagnosis of gestational hypertension; clinical diagnosis of preeclampsia.

How the Study Was Run

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

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

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

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 2021-07-01 with completion listed for 2022-01-22.

It ran at 2 sites in Turkey (Türkiye) (2).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Hemogram status (time frame: Postoperative 8th 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 156 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.