World Maternal Antifibrinolytic Trial_2

Summary

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.

Conditions

• Intrapartum - Moderate and Severe Anaemia

Interventions

DRUG

Tranexamic Acid

Ampoules and packaging for both arms will be identical in appearance.

OTHER

Placebo

Ampoules and packaging for both arms will be identical in appearance.

Sponsors & Collaborators

• Wellcome Trust

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  lead OTHER

Principal Investigators

• Ian Roberts · Clinical Trials Unit, London School of Hygiene and Tropical Medicine

• Haleema Shakur-Still · Clinical Trials Unit, London School of Hygiene and Tropical Medicine

• Rizwana Chaudhri · National Coordinating Investigator, Shifa Tameer-e-Millat University, Pakistan

• Folasade A Bello · National Coordinating Investigator, College of Medicine, University of Ibadan, Nigeria

• Bellington Vwalika · National Coordinating Investigator, University of Zambia School of Medicine, Zambia

• Projestine Muganyizi · National Coordinating Investigator, Muhimbili University of Health and Allied Sciences, Tanzania

• Oladapo Olayemi · National Coordinating Investigator, College of Medicine, University of Ibadan, Nigeria

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-24

Primary Completion

2023-09-20

Completion

2023-10-29

Countries

• Nigeria
• Pakistan
• Tanzania
• Zambia

Study Locations