Title :

Characterisation of a high-risk profile for maternal thrombotic and severe haemorrhagic complications in pregnant women with antiphospholipid syndrome in France (GR2): a multicentre, prospective, observational study

Author(s) :

Murarasu, Anne [Auteur]
Service de médecine interne et centre de référence des maladies rares [CHU Cochin]
Centre for Research in Epidemiology and Statistics | Centre de Recherche Épidémiologie et Statistiques [CRESS (U1153 / UMR_A 1125)]
Guettrot-Imbert, Gaëlle [Auteur]
Service de médecine interne et centre de référence des maladies rares [CHU Cochin]
Le Guern, Véronique [Auteur]
Service de médecine interne et centre de référence des maladies rares [CHU Cochin]
Yelnik, Cécile [Auteur]
Facteurs de Risque et Déterminants Moléculaires des Maladies liées au Vieillissement - U 1167 [RID-AGE]
Queyrel, Viviane [Auteur]
Hôpital Pasteur [Nice] [CHU]
Schleinitz, Nicolas [Auteur]
Hôpital de la Timone [CHU - APHM] [TIMONE]
Ferreira-Maldent, Nicole [Auteur]
CHU Trousseau [Tours]
Diot, Elisabeth [Auteur]
CHU Trousseau [Tours]
Urbanski, Geoffrey [Auteur]
Centre Hospitalier Universitaire d'Angers [CHU Angers]
Pannier, Emmanuelle [Auteur]
Maternité Port-Royal [CHU Cochin]
Lazaro, Estibaliz [Auteur]
Hôpital Haut-Lévêque [CHU Bordeaux]
Souchaud-Debouverie, Odile [Auteur]
Centre hospitalier universitaire de Poitiers = Poitiers University Hospital [CHU de Poitiers [La Milétrie]]
Orquevaux, Pauline [Auteur]
Hôpital Robert Debré
Belhomme, Nicolas [Auteur]
Institut de recherche en santé, environnement et travail [Irset]
École des Hautes Études en Santé Publique [EHESP] [EHESP]
Morel, Nathalie [Auteur]
Service de médecine interne et centre de référence des maladies rares [CHU Cochin]
Chauvet, Elodie [Auteur]
Centre Hospitalier Saint Jean de Perpignan
Maurier, François [Auteur]
Le Besnerais, Maëlle [Auteur]
Physiopathologie, Autoimmunité, maladies Neuromusculaires et THErapies Régénératrices [PANTHER]
Abisror, Noémie [Auteur]
CHU Saint-Antoine [AP-HP]
Goulenok, Tiphaine [Auteur]
AP-HP - Hôpital Bichat - Claude Bernard [Paris]
Sarrot-Reynauld, Françoise [Auteur]
Centre Hospitalier Universitaire [CHU Grenoble] [CHUGA]
Deroux, Alban [Auteur]
Centre Hospitalier Universitaire [CHU Grenoble] [CHUGA]
Pasquier, Elisabeth [Auteur]
Département de Médecine Interne et Pneumologie [Brest] [DMIP - Brest]
De Moreuil, Claire [Auteur]
Département de Médecine Interne et Pneumologie [Brest] [DMIP - Brest]
Bezanahary, Holy [Auteur]
Hôpital Dupuytren [CHU Limoges]
Perard, Laurent [Auteur]
Centre hospitalier Saint Joseph - Saint Luc [Lyon]
Limal, Nicolas [Auteur]
Hôpital Henri Mondor
Langlois, Vincent [Auteur]
Groupe Hospitalier du Havre Hôpital Jacques Monod (MONTIVILLIERS) [GHH]
Calas, Anne [Auteur]
Polyclinique Saint Laurent [Rennes]
Godeau, Bertrand [Auteur]
Hôpital Henri Mondor
Lavigne, Christian [Auteur]
Centre Hospitalier Universitaire d'Angers [CHU Angers]
Hachulla, Eric [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Cohen, Fleur [Auteur]
CHU Pitié-Salpêtrière [AP-HP]
Benhamou, Ygal [Auteur]
CHU Rouen
Raffray, Loïc [Auteur]
Service de médecine interne, médecine vasculaire et dermatologie Nord
de Menthon, Mathilde [Auteur]
Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
Tieulie, Nathalie [Auteur]
Centre Hospitalier Universitaire de Nice [CHU Nice]
Poindron, Vincent [Auteur]
Centre Hospitalier Universitaire [Strasbourg] [CHU Strasbourg]
Mouthon, Luc [Auteur]
Centre de référence des maladies auto-immunes systémiques rares d'Île-de-France / National Reference Center for Rare Systemic Autoimmune Diseases
Larosa, Maddalena [Auteur]
Eltfant, Elisabeth [Auteur]
Hôpital Trousseau
Sentilhes, Loic [Auteur]

Molto, Anna [Auteur]
Hôpital Hôtel-Dieu [Paris]
Deneux-Tharaux, Catherine [Auteur]
Costedoat-Chalumeau, Nathalie [Auteur]
Hôpital Cochin [AP-HP]
Centre for Research in Epidemiology and Statistics | Centre de Recherche Épidémiologie et Statistiques [CRESS (U1153 / UMR_A 1125)]
Obstetrical, Perinatal and Pediatric Epidemiology | Épidémiologie Obstétricale, Périnatale et Pédiatrique [EPOPé [CRESS - U1153 / UMR_A 1125]]

Journal title :

The Lancet Rheumatology

Abbreviated title :

Lancet Rheumatol.

Volume number :

4

Pages :

-

Publication date :

2023-03-13

ISSN :

2665-9913

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

BackgroundProspective data about the risks of thrombotic and severe haemorrhagic complications during pregnancy and post partum are unavailable for women with antiphospholipid syndrome. We aimed to assess thrombotic and ...
Show more >BackgroundProspective data about the risks of thrombotic and severe haemorrhagic complications during pregnancy and post partum are unavailable for women with antiphospholipid syndrome. We aimed to assess thrombotic and haemorrhagic events in a prospective cohort of pregnant women with antiphospholipid syndrome.MethodsThis multicentre, prospective, observational study was done at 76 centres in France. To be eligible for this study, women had to have diagnosis of antiphospholipid syndrome; have conceived before April 17, 2020; have an ongoing pregnancy that had reached 12 weeks of gestation; and be included in the study before 18 weeks of gestation. Exclusion criteria were active systemic lupus erythematosus nephropathy, or a multifetal pregnancy. Severe haemorrhage was defined as the need for red blood cell transfusion or maternal intensive care unit admission because of bleeding or invasive procedures, defined as interventional radiology or surgery, to control bleeding. The GR2 study is registered with ClinicalTrials.gov, NCT02450396.FindingsBetween May 26, 2014, and April 17, 2020, 168 pregnancies in 27 centres met the inclusion criteria for the study. 89 (53%) of 168 women had a history of thrombosis. The median term at inclusion was 8 weeks gestation. 16 (10%) of 168 women (95%CI 5–15) had a thrombotic (six [4%] women; 95% CI 1–8) or severe haemorrhagic event (12 [7%] women; 95% CI 4–12). There were no deaths during the study. The main risk factors for thrombotic events were lupus anticoagulant positivity at inclusion (six [100%] of six women with thrombosis vs 78 [51%] of 152 of those with no thrombosis; p=0·030) and placental insufficiency (four [67%] of six women vs 28 [17%] of 162 women; p=0·013). The main risk factors for severe haemorrhagic events were pre-existing maternal hypertension (four [33%] of 12 women vs 11 [7%] of 156 women; p=0·014), lupus anticoagulant positivity at inclusion (12 [100%] of 12 women vs 72 [49%] of 146 women; p<0·0001) and during antiphospholipid history (12 [100%] of 12 women vs 104 [67%] of 156 women; p=0·019), triple antiphospholipid antibody positivity (eight [67%] of 12 women vs 36 [24%] of 147 women; p=0·0040), placental insufficiency (five [42%] of 12 women vs 27 [17%] of 156 women; p=0·038), and preterm delivery at 34 weeks or earlier (five [45%] of 11 women vs 12 [8%] of 145 women; p=0·0030).InterpretationDespite treatment adhering to international recommendations, a proportion of women with antiphospholipid syndrome developed a thrombotic or severe haemorrhagic complication related to pregnancy, most frequently in the post-partum period. Lupus anticoagulant and placental insufficiency were risk factors for these life-threatening complications. These complications are difficult to prevent, but knowledge of the antenatal characteristics associated with them should increase awareness and help physicians manage these high-risk pregnancies.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
Inserm
CHU Lille

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Submission date :

2024-01-12T11:32:17Z
2024-03-07T13:00:47Z