Control of Blood Loss During Caesarean Section

What Was Tested

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

Trial of 3 protocols to determine the best one to control blood loss during caesarean section.

It had three arms (groups): oxytocin bolus (active comparator), oxytocin bolus & oxytocin infusion (active comparator) and misoprostol intrauterine (active comparator).

The registry classes the interventions as drug.

More on the Plan

The study population will be divided into 3 groups each containing 200 women: Group (A): 200 patients will receive 5-IU oxytocin bolus over 3 minutes after delivery of the baby.

Operative blood loss will be estimated in theatre based on the volume in the suction bottle and the weight of swabs used.

The researchers will record blood loss up until the time the woman will be discharged from the theatre recovery ward.

Who Took Part

Enrollment: 600 actual participants took part.

It was open to women only aged from 25 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Patients booked for elective cesarean section. Primigravida or multipara ,first cesarean section or previous .

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: patients with obstetric hemorrhage; uterine laceration; placenta previa.

How the Study Was Run

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

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

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

Only one side, usually the participants, was kept unaware of whether Oxytocin was given.

Those kept unaware of assignments: participant.

It started in 2011-09 with completion listed for 2014-09.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: amount of blood loss (time frame: 12 month).

It also tracked 1 secondary outcome, for example Haemoglobin % and haematocrit value.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in 600 people.

With 600 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.