Carbetocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With BMI ≥ 40kg/m2

What Was Tested

The trial (not phased) is built around Carbetocin.

Postpartum hemorrhage (PPH) due to uterine atony is a major cause of maternal morbidity and mortality.

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

Carbetocin is a synthetic oxytocin analogue.

It causes uterine contraction via the same mechanism as oxytocin.

Laboratory studies show that BMI alone appears to contribute to blunted uterine muscle responses and therefore contraction responses to oxytocin in obese women.

Who Took Part

The registry lists 30 actual participants took part.

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

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

Examples of who could join: Elective cesarean delivery under regional anesthesia. Gestational age ≥ 37 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 carbetocin or oxytocin; hepatic, renal, and vascular disease.

How the Study Was Run

Design: 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.

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

Neither the participants nor the staff measuring them knew who was on Carbetocin, so expectations could not easily colour the readings.

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

It started in 2018-11-19 with completion listed for 2019-05-16.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Intraoperative requirement for additional uterotonic medication (time frame: 1 hour).

It also tracked 17 secondary outcomes, for example Uterine tone 2 minutes, Uterine tone 5 minutes, Additional uterotonics administered, Estimated blood loss, Intravenous fluid administered during surgery and Presence of ventricular tachycardia: 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.