Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium

What Was Tested

This registered not phased trial tested Oxytocin and Carbetocin.

This study will investigate the effects of drugs called "uterotonics" that help with the contraction of the uterus after a baby is born.

This uterine contraction is very important to stop the bleeding after delivery.

It had five arms (groups): Carbetocin (active comparator), Oxytocin (active comparator), Ergometrine (active comparator), Carboprost (active comparator) and Control (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Postpartum hemorrhage (PPH) remains to be one of the leading causes of maternal morbidity and mortality.

According to current guidelines for medical management of PPH, the first line therapy for post CD uterotonic agent in Canada is carbetocin.

It is also unknown if prior carbetocin administration would affect myometrial contractility induced by other second line uterotonics such as ergometrine or carboprost.

This will help them better understand the comparative myometrial contractility response for a range of uterotonics.

Who Took Part

Enrollment: 32 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Patients who give written consent to participate in this study. Patients with gestational age 37-41 weeks. Non-laboring patients, not exposed to exogenous oxytocin. Patients requiring elective primary or first repeat CD. Patients undergoing CD under spinal anesthesia.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: patient refusal; patients who require general anesthesia; patients in labour and those receiving oxytocin for induction of labour.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-04-04 with completion listed for 2026-12.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Motility index (time frame: 4 hours).

It also tracked 3 secondary outcomes, for example Amplitude of contraction, Frequency of contraction and Integrated area under response curve (AUC).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin and Carbetocin in 32 people.

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

It is still recruiting; 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.