WOMAN trial collaborative group. 2020. The WOMAN (World Maternal Antifibrinolytic) Trial Dataset. [Online]. London School of Hygiene & Tropical Medicine, London, United Kingdom. Available from: https://doi.org/10.17037/DATA.00001811.
WOMAN trial collaborative group. The WOMAN (World Maternal Antifibrinolytic) Trial Dataset [Internet]. London School of Hygiene & Tropical Medicine; 2020. Available from: https://doi.org/10.17037/DATA.00001811.
WOMAN trial collaborative group (2020). The WOMAN (World Maternal Antifibrinolytic) Trial Dataset. [Data Collection]. London School of Hygiene & Tropical Medicine, London, United Kingdom. https://doi.org/10.17037/DATA.00001811.
Alternative Title
Tranexamic acid for the treatment of postpartum haemorrhage: an international randomised, double blind placebo controlled trial
Description
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.
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. | ||||
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Data capture method | Questionnaire: Fixed form | ||||
Data Collection Period |
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Date (Date submitted to LSHTM repository) | 7 July 2020 | ||||
Language(s) of written materials | English |
Data Creators | WOMAN trial collaborative group |
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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 |
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Date Deposited | 21 Jul 2020 11:36 |
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Last Modified | 24 May 2023 10:15 |
Publisher | London School of Hygiene & Tropical Medicine |
Downloads
Data / Code
Restricted to: Request access for all
Filename: WOMAN_trial_dataset.csv
Description: Anonymised dataset containing entry and outcome data for 20,060 patients. Data may be accessed by visiting https://freebird.lshtm.ac.uk.
Licence: Data Sharing Agreement
Content type: Dataset
File size: 46B
Mime-Type: text/plain
Documentation
Filename: WOMAN_Trial_Protocol_v1.1.pdf
Description: The trial protocol covering the objective(s), design, methodology, statistical considerations and organisation of the WOMAN trial
Content type: Textual content
File size: 4MB
Mime-Type: application/pdf
Filename: WOMAN_trial_dataset_userguide.html
Description: User guide for WOMAN Trial Dataset
Content type: Textual content
File size: 5kB
Mime-Type: text/html