The Use of Oxytocin, Carbetocin and Buccal Misoprostol in Patients Undergoing Elective Cesarean Section (CS)

What Was Tested

In this phase 3 trial, researchers set out to test Carbetocin.

The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective Cesarean Section.

It had three arms (groups): Syntocinon (active comparator), Carbetocin (active comparator) and Misoprostol (active comparator).

Drug is given just after delivery of the neonate during cesarean section.

Drug is given just after delivery of the neonate during cesarean section.

Drug is given just after delivery of the neonate during cesarean section.

The registry classes the interventions as drug.

Who Took Part

The registry lists 270 actual participants took part.

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

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

Examples of who could join: Age 18 years or more. Gestational age of pregnancy of 37 completed weeks or more. Written and signed informed consent by the patient to participate in the study.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: fetal or maternal distress where, due to time constraints, it will not possible and/or appropriate to recruit or randomize; women undergoing caesarean section with general anesthesia are also excluded, because carbetocin is licensed for use with regional anaesthesia only; women planned to have any other type of uterine incision other than transverse lower segment.

How the Study Was Run

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

The participants were allocated by chance, so the Carbetocin group and the comparison group should start out alike.

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 2012-12 with completion listed for 2013-08.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

It also tracked 1 secondary outcome, for example Adverse events recorded during the study.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Carbetocin in 270 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.