Tranexamic Acid for the Prevention of Postpartum Bleeding in Women With Anaemia: an International, Randomised, Double-blind, Placebo Controlled Trial.

WOMAN_2

Postpartum haemorrhage (PPH) is responsible for about 100,000 maternal deaths every year, almost all of which occur in low and middle income countries. When given within three hours of birth, tranexamic acid reduces deaths due to bleeding in women with PPH by almost one third. However, for many women, treatment of PPH is too late to prevent death and severe morbidities. Over one-third of pregnant women in the world are anaemic and many are severely anaemic. We now want to do the WOMAN-2 trial to see if giving tranexamic acid can prevent PPH and other severe outcomes in women with moderate and severe anaemia.

2019-08-24

2023-09-20

2023-10-29

Completed

Early phase I

15068

Inclusion Criteria: * Women with moderate or severe anaemia (haemoglobin level \<100 g/L or packed cell volume \<30%) after giving birth vaginally where the responsible clinician is substantially uncertain whether to use TXA Exclusion Criteria: * Women who are not legally adult (\<18 years) and not accompanied by a guardian * Women with a known allergy to tranexamic acid or its excipients * Women who experience postpartum haemorrhage before the umbilical cord is cut or clamped.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomised, double blind, placebo controlled trial among 15,000 women with moderate or severe anaemia having given birth vaginally.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': "Masking was done by an independent clinical trials supply company. It will involve the removal of the original manufacturer's label and replacement with the clinical trial label bearing the randomisation number, which will be used as the pack identification. Apart from the randomisation number, all pack label texts will be identical for tranexamic acid and placebo.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 15068, 'type': 'ACTUAL'}}

2024-01-10