Carbetocin Versus Buccal Misoprostol Plus IV Tranexamic Acid for Prevention of Postpartum Hemorrhage at Cesarean Section

What Was Tested

This registered not phased trial tested Carbetocin.

Oxytocin is regarded as the gold standard uterotonic agent but only has a half-life of 4-10 min; therefore, at cesarean section oxytocin must be administered as a continuous intravenous infusion to attain sustained uterotonic activity throughout the surgical procedure and immediate postpartum period.

It had two arms (groups): carbetocin (active comparator) and Tranexamic acid plus misoprostol (experimental).

The registry classes the interventions as drug.

More on the Plan

The misoprostol and placebo tablets were similar in size, shape, and color, and ampoules of TA and carbetocin will be also similar to placebo.

Randomization was done by the resident doctors immediately before transfer to the theater, whereas preparation of packets and confidential record maintenance was done by the labor room nursing staff.

Who Took Part

Enrollment: 400 actual participants took part.

It was open to women only aged from 20 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Pregnant women scheduled for an elective cesarean section with at least one risk factor for postpartum hemorrhage.

The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: suspected coagulopathy; women refuse to participate; emergent cesarean section.

How the Study Was Run

Design: randomized, parallel-group and triple-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.

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 and investigator.

It started in 2018-12-01 with completion listed for 2020-05-30.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

It also tracked 3 secondary outcomes, for example intraoperative blood loss, post operative blood loss and Number of participants need for blood transfusion.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Carbetocin in 400 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.