Oxytocin to Decrease Blood Loss During Cesarean Section

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

It had three arms (groups): oxytocin (active comparator), oxytocin2 (active comparator) and oxytocin3 (active comparator).

The registry classes the interventions as drug.

More on the Plan

Study subjects will be randomized using a computer-generated random number sequence stratified by elective or emergency cesarean section.

At surgery, a sealed opaque envelope containing the randomization number and data sheet will be opened for each consenting patient.

The bags will be identical in appearance.

Immediately after delivery of the infant, the study solution will be infused over 30 minutes using a continuous infusion pump (666 mU/min versus 999 mU/min versus 1332mU/min).

Who Took Part

Enrollment: 200 planned participants were the target.

It was open to women only aged from 15 years up to 45 years.

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

Examples of who could join: Study subjects will be women delivering via an elective cesarean section at term.

The full record lists 2 inclusion and 14 exclusion criteria; among the exclusions: laboring women; multifetal gestation; prolonged oxytocin use (\>12 hours).

How the Study Was Run

The set-up was randomized, parallel-group and triple-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.

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

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 and investigator.

It started in 2012-07 with completion listed for 2013-02.

It ran at 1 site in Lebanon.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: The change in hemoglobin as a measure of blood loss. The change in hemoglobin is defined as the difference between the predelivery hemoglobin value and the postpartum value (time frame: 1 year).

It also tracked 1 secondary outcome, for example The need for blood transfusion and the use of additional uterotonic agents, pad weight, pad count, estimated blood loss.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 200 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, all human trials.