Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage

What Was Tested

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

Double blinded randomized controlled study.

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

The registry classes the interventions as drug.

More on the Plan

Women will be randomized into two groups using COMPUTER-GENERATED RANDOM NUMBER LIST. 264 dark colored envelops will be serially numbered containing the corresponding letter of the corresponding drug that will be used.

The need for blood transfusion or operative interventions related to PPH \- The need for blood transfusion or operative intervention (B-Lynch sutures, uterine artery ligation, internal iliac artery ligation, Hysterectomy) will be considered. 3.

The change in hemoglobin and hematocrit post versus pre CS \- The drop in hemoglobin level and hematocrit will be evaluated by comparing the hemoglobin concentration on admission and 24 hours after delivery. 4.

Who Took Part

264 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.

Examples of who could join: Presence of uterine fibroid. Presence of placenta previa. Past History of PPH.

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: cardiac, renal, liver diseases; history of hypersensitivity to carbetocin.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 care provider.

It started in 2015-02 with completion listed for 2016-09.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): amount of blood loss (time frame: 24 hours).

It also tracked 2 secondary outcomes, for example need for another uterotonic medication and need for blood transfusion or operative intervention.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin and Carbetocin in 264 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.