Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section

What Was Tested

The trial (phase 3) is built around Oxytocin.

It had two arms (groups): Group A (experimental) and Group B (active comparator).

The registry classes the interventions as drug.

More on the Plan

Estimated blood loss (EBL) using the difference in hematocrit values taken prior to and 48 hours after caesarean delivery.

The investigators will also note the standard EBL based on estimates made by the anaesthetist after assessment of patient's linen and abdominal swabs.

COSTS AND COMPENSATION Study participants will not receive any compensation.

The cost of TXA shall not be incurred by the study participants.

Who Took Part

506 actual participants took part.

It was open to women only.

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

Examples of who could join: Pregnant woman with signed informed consent\*\*\*. Understand English and/or Shona. Estimated gestational age of 38 weeks or older. Requiring Elective Caesarean Section defined as caesarean section performed before onset of labour. Live intrauterine fetus.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: placental abruption; emergency caesarean section; known coagulopathy or history of deep venous thrombosis and/or pulmonary embolism, or arterial thrombosis (angina pectoris, myocardial infarction, stroke).

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2018-04-08 with completion listed for 2018-12-31.

It ran at 2 sites in Zimbabwe (2).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Number of Participants With Postpartum Haemorrhage (PPH) (time frame: Up to 48 hours post-caesarean section).

It also tracked 12 secondary outcomes, for example Estimated Blood Loss, Amount of Blood Transfused, Number of Participants With Use of Additional Uterotonics, Number of Participants With Tranexamic Acid Side Effects, Number of Participants Requiring Emergency Surgery for PPH and Number of Days of Participants' Hospital Stay.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in 506 people.

With 506 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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