Clinical Study to Assess the Equivalence of Tranexamic Acid vs Oxytocin in Reducing the PPH

What Was Tested

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

PPH is called "primary" when blood loss arose within 24 hours after birth.

It had two arms (groups): arm A (TXA) (experimental) and arm B (OXY) (active comparator).

The registry classes the interventions as drug.

More on the Plan

The randomization 1:1 (block design), generated by the computer.

Primary outcomes: assessment of total blood loss expressed in mL: * immediately after delivery * two hours after delivery The measurement of the overall blood loss at delivery (ml) will be performed by the graduated bag, immediately after birth.

The measurement two hours after delivery will be performed by weighing of the adsorbent material \[ N.ml = N. gr indicated by the balance - dry weight of the sanitary napkin\].

The overall loss in blood measured (ml) two hours of delivery will then be performed by adding the two collections.

Who Took Part

256 actual participants took part.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: Subjects full capacity and the willingness to give written informed consent .

The full record lists 2 inclusion and 15 exclusion criteria; among the exclusions: subjects with preterm pregnancy (\<37 weeks ) or with prolonged pregnancy ( \> 42 weeks ); subjects at the end of pregnancy ( 37 weeks - 42 weeks ) with the following risk factors for pph (tab1.protocol study, vers.2.0 of 07/05/2016); multiple pregnancy.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Being open-label, the Oxytocin study did not mask who received what.

It started in 2018-01-30 with completion listed for 2018-12-31.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: assessment of total blood loss expressed in mL (time frame: immediately after delivery). assessment of total blood loss expressed in mL (time frame: two hours after delivery).

It also tracked 8 secondary outcomes, for example assessment of the number of hemodynamic changes, assessment of the number of hemodynamic changes, assessment of the need of using additional uterotonic, assessment of the need of using additional uterotonic, assessment the need for surgical manoeuvres for the bleeding control and assessment the need for surgical manoeuvres for the bleeding control.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in 256 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.