Evidence map›Paper›PMID 40448004›Full record

ArticleBMC pregnancy and childbirth2025

Study protocol. TRAAPREVIA-TRAnexamic acid for preventing blood loss following a cesarean delivery in women with a placenta pREVIA or low-lying placenta: a multicenter randomized, double blind, placebo controlled trial.

Loïc Sentilhes, Hugo Madar, Amélie Ifrah, Jean-Marie Chrétien, Catherine Deneux-Tharaux, TRAAPREVIA Study Group, the Groupe de Recherche en Obstétrique et Gynécologie (GROG)

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC pregnancy and childbirth, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04304625 (TRAnexamic Acid for Preventing Blood Loss Following a Cesarean Delivery in Women With Placenta pREVIA), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04304625 phase3recruitingnot on this map

TRAnexamic Acid for Preventing Blood Loss Following a Cesarean Delivery in Women With Placenta pREVIA: a Multicenter Randomised, Double Blind Placebo Controlled Trial

TypeinterventionalSponsorUniversity Hospital, BordeauxRan2020 to 2027Enrolled1,380ConditionsPostpartum HemorrhageArmsTranexamic Acid / Sodium chloride
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Loïc SentilhesDepartment of Obstetrics and Gynecology, Bordeaux University Hospital, Place Amélie Raba Léon, 33076, Bordeaux, France. loicsentilhes@hotmail.com.
Hugo MadarDepartment of Obstetrics and Gynecology, Bordeaux University Hospital, Place Amélie Raba Léon, 33076, Bordeaux, France.
Amélie IfrahDepartment of Pharmacy, Angers University Hospital, Angers, France.
Jean-Marie ChrétienDepartment of Data Science, Clinical Research and Innovation Direction, Angers University Hospital, Angers, France.
Catherine Deneux-TharauxObstetrical Perinatal and Pediatric Lifelong Epidemiology Research Team (OPPaLE), Center for Research On Epidemiology and Statistics (CRESS) U1153, Université Paris Cité, Institut Santé Des Femmes, INSERM, INRAE, Paris, France.
TRAAPREVIA Study Group, the Groupe de Recherche en Obstétrique et Gynécologie (GROG)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPlacentas that are previa or low-lying are a major cause of severe postpartum hemorrhage (PPH). Tranexamic acid, by inhibiting the fibrinolytic pathway and protecting blood clots from degradation, is a promising drug for preventing blood loss after childbirth, especially in high-risk conditions. It remains unclear whether tranexamic acid would decrease the incidence of severe PPH among women with placentas that are previa or low-lying. METHODS AND

designThis multicenter, double-blind, randomized controlled trial with two parallel groups will include 1380 women with placenta previa or a low-lying placenta and a cesarean delivery at a term ≥ 32 weeks, modeled on our previous study of tranexamic acid administered after cesarean deliveries (TRAAP2). Women with high antenatal suspicion of placenta accreta spectrum will not be included. Treatment (either tranexamic acid 1 g or placebo) will be administered intravenously just after birth. All women will also receive a prophylactic uterotonic agent. The primary outcome will be the incidence of a red blood cell transfusion before discharge. This study will have a 90% power to show a 33% reduction in the incidence of transfusion, from 20.0% to 13.4%. DISCUSSION: This large multicenter, randomized placebo-controlled trial aims to determine with adequate power if the prophylactic use of tranexamic acid among women with cesarean delivery and a placenta that is previa or low-lying would decrease the incidence of transfusion.

trial registrationClinicalTrials.gov NCT04304625 (March 9, 2020).

Indexed as

Antifibrinolytic AgentsCesarean SectionPlacenta PreviaPostpartum HemorrhageTranexamic AcidAdultDouble-Blind MethodFemaleHumansMulticenter Studies as TopicPregnancyRandomized Controlled Trials as TopicAntifibrinolytic AgentsTranexamic AcidCesarean deliveriesLow-lying placentaPlacenta previaPostpartum hemorrhagePreventionRandomized trialThrombosisTranexamic acidTransfusionTreatment

Identifiers

PMID40448004
PMCPMC12123741

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.