Carbetocin Versus Oxytocin and Ergometrine for the Prevention of Postpartum Hemorrhage

What Was Tested

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

Uterine atony is the most common cause of immediate heavy PPH.Multiple pregnancy ones of a common factor for uterine atony.

It had two arms (groups): carbetocin arm (experimental) and oxytocin and ergometrine arm (active comparator).

The registry classes the interventions as drug.

More on the Plan

Also, intramuscular injection of ergometrine did the same.

All women were subjected to full history taking, general and obstetric examination and investigations in the form of preoperative routine labs and obstetric ultrasound, and postoperative serum hemoglobin %.

Who Took Part

220 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: Women with a multiple term pregnancy undergoing elective cesarean section.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: single gestation; placenta praevia and placental abruption; undergoing cesarean section with general anesthesia.

How the Study Was Run

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

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

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

In this single-blind Oxytocin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2018-04-01 with completion listed for 2020-03-31.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): estimation of intraoperative blood loss (ml) (time frame: intraoperative).

It also tracked 2 secondary outcomes, for example need for blood transfusion and Hemoglobin concentration.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin and Carbetocin in 220 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.