10.17037/DATA.00002164
Supplementary information that supports the manuscript, “WOMAN-PharmacoTXA trial: Study protocol for a randomised controlled trial to assess the pharmacokinetics and pharmacodynamics of intramuscular, intravenous and oral administration of tranexamic acid in women giving birth by caesarean section”.
Files are made available under a Creative Commons 4.0 Attribution (CC BY 4.0) licence.
Pharmacokinetics, Pharmacodynamics, Tranexamic acid, alternative routes, Caesarean Section, Pregnancy, PPH, Postpartum hemorrhage, intramuscular
English
Written signatures were removed by the study team prior to submission.
| Project name | Funder/sponsor | Grant number |
| WOMAN-PharmacoTXA | Wellcome Trust | 208870 |
| WOMAN-PharmacoTXA | Bill and Melinda Gates Foundation | OPP1176150 |
| Forename | Surname | Faculty / Dept | Institution | Role |
| Haleema | Shakur-Still | Faculty of Epidemiology and Population Health / Department of Population Health | London School of Hygiene & Tropical Medicine | Data Creator |
| Monica | Arribas | Faculty of Epidemiology and Population Health / Department of Population Health | London School of Hygiene & Tropical Medicine | Data Creator |
| Ian | Roberts | Faculty of Epidemiology and Population Health / Department of Population Health | London School of Hygiene & Tropical Medicine | Data Creator |
| Rizwana | Chaudhri | Shifa Tameer-e-Millat University, Pakistan | Data Creator | |
| Amber | Geer | Faculty of Epidemiology and Population Health / Department of Population Health | London School of Hygiene & Tropical Medicine | Data Creator |
| Danielle | Prowse | Faculty of Epidemiology and Population Health / Department of Population Health | London School of Hygiene & Tropical Medicine | Data Creator |
| Mwansa Ketty | Lubeya | Women and Newborn Hospital, Lusaka, Zambia | Data Creator | |
| Aasia | Kayani | Shifa Tameer-e-Millat University, Pakistan | Data Creator | |
| Kiran | Javaid | Shifa Tameer-e-Millat University, Pakistan | Data Creator | |
| Stanislas | Grassin Delyle | Université Paris-Saclay, UVSQ, France | Data Creator |
The following files are licensed under a Creative Commons 4.0 Attribution (CC BY 4.0) licence.
| File name | Description | Access status | Licence |
| File01-SPIRIT_checklist | SPIRIT guidelines for WOMAN-PharmacoTXA trial | Open to all | Creative Commons Attribution (CC BY) |
| File02-WHO_trial_registration_dataset | WHO WOMAN-PharmacoTXA trial registration dataset | Open to all | Creative Commons Attribution (CC BY) |
| File03-WOMAN_PharmacoTXA_protocol | Trial Protocol | Open to all | Creative Commons Attribution (CC BY) |
| File04-PIS_and_consent_form | Patient Information Sheet and Consent form | Open to all | Creative Commons Attribution (CC BY) |
| File05-Consent_procedure_overview | Trial overview of the Consent procedure | Open to all | Creative Commons Attribution (CC BY) |
| File06_Safety_reporting_flowchart | Trial safety reporting flowchart | Open to all | Creative Commons Attribution (CC BY) |
| File07-Main_contacts | Contact details of the Clinical Trials Unit- LSHTM and Sponsor | Open to all | Creative Commons Attribution (CC BY) |
| File08-DMC_Composition | Composition of the Data Monitoring Committee | Open to all | Creative Commons Attribution (CC BY) |
| File09-LSHTM_Ethics_Approval | LSHTM (Sponsor) Ethics Approval Letter | Open to all | Creative Commons Attribution (CC BY) |
| File10-UNZABREC_Approval | UNZABREC Approval Letter | Open to all | Creative Commons Attribution (CC BY) |
| File11-ZAMRA_Approval | ZAMRA Approval letter | Open to all | Creative Commons Attribution (CC BY) |
| File12-Zambia_NHREB_Approval | Zambia NHREB Approval letter | Open to all | Creative Commons Attribution (CC BY) |
| File13-Pakistan_NBC_Approval | Pakistan NBC Approval Letter | Open to all | Creative Commons Attribution (CC BY) |
| File14-DRAP_Approval | DRAP Approval Letter | Open to all | Creative Commons Attribution (CC BY) |
| File15-PIMS_Hospital_ERB_Approval | Pakistan Institute of Medical Sciences Hospital ERB Approval Letter | Open to all | Creative Commons Attribution (CC BY) |
| File16-FGPC_Hospital_LEC_Approval | Federal Government Polyclinic LEC Approval Letter | Open to all | Creative Commons Attribution (CC BY) |