Carbetocin at Cesarean Delivery for Labor Arrest

What Was Tested

This registered not phased trial tested Carbetocin.

It had eight 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

Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity.

The evidence reported for Carbetocin use in the literature has mostly been based upon low risk non-laboring patients undergoing elective cesarean deliveries.

At present, only 2 studies have looked at the use of Carbetocin in low risk patients requiring emergency cesarean deliveries.

Similar to oxytocin, the ED90 of Carbetocin is likely to be higher in laboring women undergoing Cesarean deliveries as compared to the non-laboring women, due to the effect of the desensitization phenomenon.

Who Took Part

The registry lists 40 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: All patients who have given written informed consent to participate in this study. All patients planned for uncomplicated low transverse cesarean delivery secondary to labor arrest, under epidural anesthesia. ≥37 week pregnancy. Patients who have received oxytocin for at least 4 hours for labor augmentation. ASA 1 or 2.

The full record lists 6 inclusion and 16 exclusion criteria; among the exclusions: refusal or inability to obtain informed consent; all patients who claim allergy or hypersensitivity to oxytocin and carbetocin; previous history of uterine atony or pph.

How the Study Was Run

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

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

Blinding on both sides kept the participants and researchers unaware of who received Carbetocin.

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

It started in 2012-11 with completion listed for 2013-03.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: need for additional uterotonics (time frame: 30 minutes).

It also tracked 5 secondary outcomes, for example uterine tone, uterine tone, need for additional uterotonic, Blood loss and side effects.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Carbetocin in 40 people.

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.