Carbetocin Versus Oxytocin for the Prevention of Postpartum Hemorrhage in Emergency Caesarean Delivery

What Was Tested

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

Postpartum haemorrhage keeps to be the leading cause of maternal mortality in middle and low-income countries, including Iraq.

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

The registry classes the interventions as drug.

More on the Plan

Setting and design: It is a double blinded randomized parallel clinical trial.

Written consent was insured for all the participants.

Data collection: Three hundred and twenty pregnant women who were underwent emergency caesarean sections under regional anesthesia were enrolled in the study (due to limitation of carbetocin ampoules that were available).

Those women were randomized to oxytocin or carbetocin in a rate of 2:1 (for prophylaxis of PPH in the active management of third stage of labour).

Who Took Part

Enrollment: 300 actual participants took part.

It was open to women only aged from 18 years up to 43 years.

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

Examples of who could join: Patients age ≥18 years. Full term gestation. Emergency cesarean section during labor.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: cases of coagulopathy; drug hypersensitivity; medical diseases as; cardiac, hypertension, liver, renal or endocrine diseases.

How the Study Was Run

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

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

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

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

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

It started in 2018-01-04 with completion listed for 2018-06-10.

It ran at 1 site in Iraq.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Use of additional uterotonics (time frame: During the first 24 hours).

It also tracked 3 secondary outcomes, for example Blood pressure changes in carbetocin versus oxytocin group, Pulse rate changes in carbetocin versus oxytocin group and Blood transfusion need.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin and Carbetocin in 300 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.