https://doi.org/10.17037/DATA.00001811
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.
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.
The trial was a global collaboration, conducted in 193 hospitals across 21 countries.
100% of the data was subject to quality control data validations checks and central and statistical monitoring.
Human population
Minimal personal data was collected in the trial. Confidential information stored on the consent form was kept separately from the trial data and will be destroyed within five years of the trial ending.
The data has been anonymised of any personal data prior to sharing the data publicly on the data sharing Free Bank of Injury and Emergency Research Data (freeBIRD) website. This include dates, site and country information.
The appropriate national and local ethics approval were obtained for each country/hospital that recruited to the trial.
Postpartum haemorrhage, antifibrinolytic, tranexamic acid, maternal health
English
Tranexamic acid for the treatment of postpartum haemorrhage: an international randomised, double blind placebo controlled trial
Sponsor:
Funder:
ClinicalTrials.gov, number NCT00872469
The WOMAN trial was a large global collaboration involving 6 years of recruitment from 193 hospitals. The citation should refer to the collective ‘WOMAN trial collaborative group’
| Forename | Surname | Faculty / Dept | Institution | Role |
| Haleema | Shakur-Still | Faculty of Epidemiology and Population Health - Dept of Population Health | London School of Hygiene and Tropical Medicine | Contact person – ctu@lshtm.ac.uk |
| Filename | Description | Access status | Licence |
| WOMAN_Trial_Protocol_v1.1 | The trial protocol covering the objective(s), design, methodology, statistical considerations and organisation of the WOMAN trial | Open to all | Creative Commons Attribution (CC BY) |
| WOMAN_trial_dataset | All entry and outcome data for 20,060 patients | Request access for all | Data sharing agreement |
| WOMAN_trial_dataset_codebook | Description of each variable contained within the dataset | Open to all | Creative Commons Attribution (CC BY) |
| WOMAN_trial_dataset_userguide | User guide for dataset (this document) | Open to all | Creative Commons Attribution (CC BY) |