Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage

What Was Tested

The trial (not phased) is built around Oxytocin and Carbetocin.

It had three arms (groups): oxytocin (active comparator), oxytocin plus misoprostol (active comparator) and Carbetocin (active comparator).

The patient will be received Carbetocin 100 mic gm IV.

The registry classes the interventions as drug.

More on the Plan

The first cause of hemorrhage at the time of delivery is uterine atony; therefore, there is general agreement that active management of the third stage of labor is recommended.

Oxytocin is the most widely used uterotonic agent but has a half-life of only 4-10 min, that is why it is better administered as a continuous intravenous infusion to achieve sustained uterotonic activity.

Its prolonged uterine activity may theoretically offer advantages over oxytocin in the management of the third stage of labor.

The side-effect profile of carbetocin was not found to be different from that of Oxytocin but may prove to be advantageous when compared to Syntometrine.

Who Took Part

Enrollment: 135 actual participants took part.

It was open to women only aged from 20 years up to 40 years.

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

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: gestational age\<37 weeks,; genital tract trauma,; coagulation defect,.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

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

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2019-04-01 with completion listed for 2021-06-30.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The amount of blood loss (time frame: 6 hours post delivery).

It also tracked 2 secondary outcomes, for example The number of patient need blood transfusion.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin and Carbetocin in 135 people.

The trial is marked completed; 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.