Evidence map›Paper›PMID 32005192›Full record

ArticleBMC pregnancy and childbirth2020

TRAAP2 - TRAnexamic Acid for Preventing postpartum hemorrhage after cesarean delivery: a multicenter randomized, doubleblind, placebo- controlled trial - a study protocol.

Loïc Sentilhes, Valérie Daniel, Catherine Deneux-Tharaux, TRAAP2 Study Group and the Groupe de Recherche en Obstétrique et Gynécologie (GROG)

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC pregnancy and childbirth, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03431805 (TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
4.6field-weighted citation impact, top 4% of its field
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.

NCT03431805 phase3completednot on this map

TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery :a Multicenter Randomised, Double Blind Placebo Controlled Trial (TRAAP2)

TypeinterventionalSponsorUniversity Hospital, BordeauxRan2018 to 2020Enrolled4,574ConditionsPostpartum HemorrhageArmsTranexamic Acid Injectable Solution, Sodium Chloride 0.9%
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Tranexamic acid for preventing postpartum haemorrhage after vaginal birth.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Pooled it
  3. Trial
  4. Effect of Prophylactic Intraoperative Tranexamic Acid on Postpartum Blood Loss Following Cesarean Section at a Single Center.Medical science monitor : international medical journal of experimental and clinical research · 2025
    Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Article
  10. Tranexamic acid evidence and controversies: An illustrated review.Research and practice in thrombosis and haemostasis · 2021
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 1 country.

Loïc SentilhesDepartment of Obstetrics and Gynecology, Bordeaux University Hospital, Place Amélie Raba Léon, 33076, Bordeaux, France. loicsentilhes@hotmail.com.ORCID http://orcid.org/0000-0003-0009-3625
Valérie DanielDepartment of Obstetrics and Gynecology, Bordeaux University Hospital, Place Amélie Raba Léon, 33076, Bordeaux, France.
Catherine Deneux-TharauxINSERM U1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Center for Epidemiology and Statistics, Sorbonne Paris Cité, DHU Risks in Pregnancy, Paris Descartes University, Paris, France.
TRAAP2 Study Group and the Groupe de Recherche en Obstétrique et Gynécologie (GROG)
Université de Bordeaux · FRCentre de Recherche Épidémiologie et Statistique · FRInserm · FR

Funding

French Ministry of Health PHRC-15-0011
6 · The paper itself

Abstract

backgroundAn antifibrinolytic agent that blocks lysine-binding sites on plasminogen molecules, tranexamic acid reduces bleeding-related mortality in women with postpartum hemorrhage (PPH), especially administered fairly soon after delivery. According to the randomized controlled trials thus far reported for PPH prevention after cesarean deliveries (n = 16), women who received tranexamic acid had significantly less postpartum blood loss and no increase in severe adverse effects. These were, however, primarily small single-center studies that had fundamental methodological flaws. Multicenter randomized controlled trials with adequate power are necessary to demonstrate its value persuasively before tranexamic acid goes into widespread use for the prevention of PPH after cesarean deliveries. METHODS/

designThis study will be a multicenter, double-blind, randomized controlled trial with two parallel groups including 4524 women with cesarean deliveries before or during labor, at a term ≥34 weeks, modeled on our previous study of tranexamic acid administered after vaginal deliveries. 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 PPH, defined by a calculated estimated blood loss > 1000 mL or a red blood cell transfusion before day 2 postpartum. This study will have 80% power to show a 20% reduction in the incidence of PPH, from 15.0 to 12.0%. DISCUSSION: As an, inexpensive, easy to administer drug that can be add to the routine management of cesarean births in delivery rooms, tranexamic acid is a promising candidate for preventing PPH after these births. This large, adequately powered, multicenter randomized placebo-controlled trial seeks to determine if the benefits of the routine prophylactic use of tranexamic acid after cesarean delivery significantly outweigh its risks.

trial registrationClinicalTrials.gov NCT03431805 (February 12, 2018).

Indexed as

Cesarean SectionAdministration, IntravenousAntifibrinolytic AgentsDouble-Blind MethodFemaleHemodynamic MonitoringHumansMulticenter Studies as TopicPostpartum HemorrhagePregnancyRandomized Controlled Trials as TopicTranexamic AcidAntifibrinolytic AgentsTranexamic AcidCesarean and vaginal deliveriesPostpartum hemorrhagePreventionRandomized trialThrombosisTranexamic acidTreatment

Identifiers

PMID32005192
PMCPMC6995226
OpenAlexW3003940593

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.