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NCT03431805: TRAAP2
TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery
Completed
Phase 3
Last updated 29 April 2020
What this trial tests
Phase 3 trial testing Tranexamic Acid Injectable Solution in Postpartum Hemorrhage in 4,574 participants. Completed in 8 April 2020.
Timeline
3 March 2018
Primary endpoint
14 January 2020
14 January 2020
8 April 2020
Quick facts
| Lead sponsor | University Hospital, Bordeaux |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 4,574 |
| Start date | 3 March 2018 |
| Primary completion | 14 January 2020 |
| Estimated completion | 8 April 2020 |
| Sites | 26 locations across France |
Drugs / interventions tested
- Tranexamic Acid Injectable Solution — full drug profile →
- Sodium Chloride 0.9%
Conditions studied
- Postpartum Hemorrhage — all drugs for Postpartum Hemorrhage →
Sponsor
University Hospital, Bordeaux
Who can join
Adults 18 to 64, female only, with Postpartum Hemorrhage. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim is to assess the impact of tranexamic acid (TXA) for preventing postpartum hemorrhage (PPH) following a cesarean section (CS).
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery.
Sentilhes L, Sénat MV, Le Lous M, Winer N, et al · · 2021 · cited 160× · PMID 33913639 · DOI 10.1056/nejmoa2028788 -
TRAAP2 - TRAnexamic Acid for Preventing postpartum hemorrhage after cesarean delivery: a multicenter randomized, doubleblind, placebo- controlled trial - a study protocol.
Sentilhes L, Daniel V, Deneux-Tharaux C, TRAAP2 Study Group and the Groupe de Recherche en Obstétrique et Gynécologie (GROG). · · 2020 · cited 27× · PMID 32005192 · DOI 10.1186/s12884-019-2718-4 -
Tranexamic acid for reduction of blood loss after Caesarean delivery: a cost-effectiveness analysis of the TRAAP2 trial.
Sentilhes L, Bénard A, Madar H, Froeliger A, et al · · 2023 · cited 7× · PMID 37690946 · DOI 10.1016/j.bja.2023.07.028 -
Association Between Surgeon Gender and Maternal Morbidity After Cesarean Delivery.
Bouchghoul H, Deneux-Tharaux C, Georget A, Madar H, et al · · 2023 · cited 7× · PMID 36696127 · DOI 10.1001/jamasurg.2022.7063 -
Tranexamic acid for preventing postpartum haemorrhage after caesarean section.
Rohwer C, Rohwer A, Cluver C, Ker K, et al · · 2024 · cited 5× · PMID 39535297 · DOI 10.1002/14651858.cd016278
Verify or expand the search:
- PubMed search for NCT03431805
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tranexamic Acid Injectable Solution
Trials testing the same drug.
- NCT03923959 — Evaluation of TXA Prior to Surgery in the Geriatric Hip Fracture Population · Phase 3 · completed
- NCT03433144 — The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery · Phase 4 · withdrawn
- NCT03101124 — Serum Concentration of Tranexamic Acid After Topical Administration in Massive Weight Loss Skin Reducing Surgery · Phase 2 · completed
Other recruiting trials for Postpartum Hemorrhage
Currently open trials in the same condition.
- NCT07401160 — Umbilical Cord Drainage to Prevent Postpartum Hemorrhage · NA · recruiting
- NCT07278037 — Trends in the Administration of Tranexamic Acid for Postpartum Hemorrhage · recruiting
- NCT07279545 — The Effect of Placental Cord Drainage on the Third Stage of Labor and the Amount of Postpartum Bleeding · NA · recruiting
- NCT07229573 — The Effectiveness of Serious Game-Based Training for Nursing Students in Postpartum Haemorrhage Management · NA · recruiting
- NCT07005349 — THUMB: Multi-centre Cluster Trial for Caesarean Section Haemorrhage · NA · recruiting
Other University Hospital, Bordeaux trials
Trials by the same sponsor.
- NCT07506928 — NEURO - Prognostication Using Late Somatosensory Evoked - Potentials · NA · not yet recruiting
- NCT07524036 — Impact of a Nursing Educational Consultation on the Patient's Adherence to Their Post-stroke Care Plan. · NA · not yet recruiting
- NCT07527494 — Digital MEDIcal TWIN for the Prediction of Arrhythmic Sudden Cardiac Death After a Myocardial Infarction · NA · not yet recruiting
- NCT07527442 — Efficacy and Safety of Circumcision Alone on Risk of Febrile Urinary Tract Infections in Boys With Posterior Urethral Va · Phase 2 · not yet recruiting
- NCT07478523 — FAPI-PET Value for the Initial Screening of Pancreatic and Biliary Cancers · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03431805 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Bordeaux
- Last refreshed: 29 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03431805.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing