Efficacy of Carbetocin Versus Oxytocin Plus Misoprostol in Decreasing Blood Loss During Cesarean Section

What Was Tested

The trial (phase 4) is built around Oxytocin and Carbetocin.

Researchers will compare 2 groups: * women receiving Oxytocin plus Misoprostol; * women receiving Carbetocin as regards: * estimated blood loss.

It had two arms (groups): Oxytocin+Misoprostol (active comparator) and Carbetocin (experimental).

The registry classes the interventions as drug.

More on the Plan

Recruitment of patients planning to undergo elective cesarean section in ASUMH from antenatal clinic. 3.

An informed written consent will be taken from all participants before enrollment in the study and after explaining the purpose, possible risks and complications. 4.

All participants will be subjected to thorough history taking, general and abdominal examination, obstetric ultrasound examination and laboratory investigations including complete blood count to identify eligible patients. 5.

Who Took Part

The registry lists 90 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Pregnant women planning to deliver by CS. Age between 18-40. Gestational age: (36-42 weeks).

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: women in active labour; rupture of membranes more than 24 hours \&/or intraamniotic infection; suspected extensive adhesions eg: more than p3cs, endometriosis, previous pelvic surgery.

How the Study Was Run

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

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

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 and outcomes assessor.

It started in 2022-12-20 with completion listed for 2023-04-30.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): estimated blood loss in millimeters (time frame: calculated once at the end of the CS).

It also tracked 1 secondary outcome, for example drop in hemoglobin.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin and Carbetocin in 90 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.