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TRAnexamic Acid for Preventing Blood Loss Following a Cesarean Delivery in Women With Placenta pREVIA

Study acronym: TRAAPrevia
StatusRecruiting
PhasePhase 3
Started2020-08-07
View on ClinicalTrials.gov ↗

Amendment history

2025-02-07
Study Status, Eligibility v5
Primary completion date2026-12-30→2027-06
Completion date2027-02-28→2027-09
Eligibility criteria-9 characters
[...] thrombotic risk (including cirrhosis, portal hypertension, ASAT>3N, Budd-Chiari syndrome) Active autoimmune disease with thrombo [...]
2023-12-06
Study Status v4
Primary completion date2023-12-30→2026-12-30
Completion date2023-12-30→2027-02-28
2023-04-27
2 amendments v2-v3
2 re-verifications since 2022-04-11, no change to tracked fields
2020-08-10
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2023-06-30→2023-12-30
Completion date2023-06-30→2023-12-30
Start dateestimated 2020-04-20→confirmed 2020-08-07
Study sitesdetails revised at 1 of 1 site
2020-03-09
Original filing
Several randomized, controlled trials, mostly involving women undergoing cesarean delivery, have shown that the prophylactic intravenous administration of 1 g of tranexamic acid after childbirth reduced blood loss. Most were small, single-centre trials with considerable methodologic limitations. It is important to emphasize that none of these RCTs has included women at increased risk of PPH such as placenta previa, a context in which the prevalence of moderate and severe blood loss is significantly higher and where the magnitude of the effect of TXA may highly differ compared to low risk women
Trial Details
NCT Number NCT04304625
Lead Sponsor University Hospital, Bordeaux
Conditions Postpartum Hemorrhage
Enrollment 1,380 participants
Start Date 2020-08-07
Primary Completion 2027-06 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2025-02-10