Effect of the Uterotonic Carbetocin on Acute Post Cesarean-Section Pain

What Was Tested

In this phase 4 trial, researchers set out to test Carbetocin.

First studies revealed in 2012 an analgesic effect of carbetocin, compared to its parent substance oxytocin.

This study will enroll 78 women undergoing cesarean delivery.

It had two arms (groups): Oxytocin (no intervention) and Carbetocin (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 78 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: Age 18-45, uneventful pregnancy, on term (\>37 0/7 weeks of gestation), scheduled elective CS including repeat CS.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: lack of informed consent, active labor, multiple pregnancy, polyhydramnios, severe fetal malformations.

How the Study Was Run

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

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

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

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 2019-02-01 with completion listed for 2020-12.

It ran at 1 site in Switzerland.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Cesarean delivery scar cutaneous hyperalgesia (time frame: 4 hours after cesarean delivery).

It also tracked 10 secondary outcomes, for example Pressure pain detection threshold, Pressure pain detection threshold, Pressure pain detection threshold, Pressure pain detection threshold, Pressure pain detection threshold and Baseline depression detection.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Carbetocin in 78 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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