The WOMAN (World Maternal Antifibrinolytic) Trial Dataset
The WOMAN trial was a large, pragmatic, randomised, double blind, placebo controlled trial to quantify the effects of the early administration of tranexamic acid on death, hysterectomy and other relevant outcomes. This dataset includes the data for 20,060 adult women, who had clinically diagnosed postpartum haemorrhage and who fulfilled the eligibility criteria, who were randomised to receive either TXA or placebo.
Relevant data on an entry form was collected before randomisation to assess eligibility and then the woman was randomised. Outcome data was completed at death, discharge from the randomising hospital or 6 weeks (42 days) after randomisation, whichever occurred first. Each row in the dataset represents the full entry and outcome data collected for one woman. Additional information was collected on the sequence of events leading to death to confirm the cause of death. Data may be accessed by visiting https://freebird.lshtm.ac.uk.
Additional Information
The trial was a global collaboration, conducted in 193 hospitals across 21 countries.
Keywords
Postpartum haemorrhage, antifibrinolytic, Tranexamic acid, Maternal healthItem Type | Dataset |
---|---|
Description of data capture | This trial was coordinated from LSHTM and conducted in hospitals from 21 countries worldwide. Data was collected at each site by local investigators and transmitted to the CTU either as a paper form (by fax or email) or by entering the data directly into the trial database. Data outlined on the entry, outcome and adverse event forms was collected for this trial. The data was collected from the woman’s and her baby/ies routine medical records; no special tests were required. |
Capture method | Questionnaire: Fixed form |
Collection Period |
From To 22 March 2010 8 July 2016 |
Date | 7 July 2020 |
Language(s) of written materials | English |
Creator(s) | WOMAN trial collaborative group |
Associated roles | Shakur-still, H (Principal Investigator) |
LSHTM Faculty/Department | Faculty of Epidemiology and Population Health > Dept of Population Health (2012- ) |
Participating Institutions | London School of Hygiene & Tropical Medicine, London, United Kingdom |
Funders |
Project Funder Grant Number Funder URI Tranexamic acid for the treatment of postpartum haemorrhage: an international randomised, double blind placebo controlled trial HICF-T2-0510-007 http://dx.doi.org/10.13039/501100000276 Tranexamic acid for the treatment of postpartum haemorrhage: an international randomised, double blind placebo controlled trial WT094947 http://dx.doi.org/10.13039/100010269 Tranexamic acid for the treatment of postpartum haemorrhage: an international randomised, double blind placebo controlled trial UNSPECIFIED http://dx.doi.org/10.13039/100000865 Tranexamic acid for the treatment of postpartum haemorrhage: an international randomised, double blind placebo controlled trial UNSPECIFIED https://www.pfizer.co.uk/ |
Date Deposited | 21 Jul 2020 11:36 |
Last Modified | 24 May 2023 10:15 |
Publisher | London School of Hygiene & Tropical Medicine |
-
subject - Documentation
- Creative Commons: Attribution
- Available under Creative Commons: Attribution 3.0
-
info - The trial protocol covering the objective(s), design, methodology, statistical considerations and organisation of the WOMAN trial
picture_as_pdf - application/pdf
- folder_info
- 4MB
-
subject - Data
-
lock - Restricted to Request access for all
- Data Sharing Agreement
- Available under Data Sharing Agreement
-
info - Anonymised dataset containing entry and outcome data for 20,060 patients. Data may be accessed by visiting https://freebird.lshtm.ac.uk.
description - text/plain
- folder_info
- 46B
-
subject - Documentation
- Creative Commons: Attribution
- Available under Creative Commons: Attribution 3.0
-
info - User guide for WOMAN Trial Dataset
html - text/html
- folder_info
- 5kB