Carbetocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy.

What Was Tested

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

Poor uterine tone after the birth of a baby can cause excess bleeding (called postpartum hemorrhage or PPH).

It had six arms (groups): one (active comparator), one (active comparator), one (active comparator), one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

There is a lack of consensus as to what the optimal uterotonic regime is globally.

Who Took Part

30 actual participants took part.

It was open to women only aged from 18 years up to 55 years.

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

Examples of who could join: Elective cesarean delivery under regional anesthesia. Gestational age ≥ 36 weeks. No known additional risk factors for postpartum hemorrhage. Written informed consent to participate in this study.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: refusal to give written informed consent; allergy or hypersensitivity to oxytocin; hepatic, renal, and vascular disease.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

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

As a double-blind Carbetocin 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 2021-10-14 with completion listed for 2023-04-27.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Uterine tone 2 minutes: questionnaire (time frame: 2 minutes).

It also tracked 16 secondary outcomes, for example Uterine tone 5 minutes: questionnaire, Additional uterotonics administered, Estimated blood loss, Intravenous fluid administered during surgery, Presence of ventricular tachycardia: ECG and Presence of atrial fibrillation: ECG.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Carbetocin in 30 people.

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

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

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