| 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 |
| Authors: |
Murarasu, Anne; Guettrot-Imbert, Gaëlle; Le Guern, Véronique; Yelnik, Cécile; Queyrel, Viviane; Schleinitz, Nicolas; Ferreira-Maldent, Nicole; Diot, Elisabeth; Urbanski, Geoffrey; Pannier, Emmanuelle; Lazaro, Estibaliz; Souchaud-Debouverie, Odile; Orquevaux, Pauline; Belhomme, Nicolas; Morel, Nathalie; Chauvet, Elodie; Maurier, François; Le Besnerais, Maëlle; Abisror, Noémie; Goulenok, Tiphaine; Sarrot-Reynauld, Françoise; Deroux, Alban; Pasquier, Elisabeth; De Moreuil, Claire; Bezanahary, Holy; Perard, Laurent; Limal, Nicolas; Langlois, Vincent; Calas, Anne; Godeau, Bertrand; Lavigne, Christian; Hachulla, Eric; Cohen, Fleur; Benhamou, Ygal; Raffray, Loïc; de Menthon, Mathilde; Tieulie, Nathalie; Poindron, Vincent; Mouthon, Luc; Larosa, Maddalena; Eltfant, Elisabeth; Sentilhes, Loic; Molto, Anna; Deneux-Tharaux, Catherine; Costedoat-Chalumeau, Nathalie |
| Contributors: |
Université de Lille; Inserm; CHU Lille; Service de médecine interne et centre de référence des maladies rares CHU Cochin; Centre for Research in Epidemiology and Statistics; Facteurs de Risque et Déterminants Moléculaires des Maladies liées au Vieillissement - U 1167 RID-AGE; Hôpital Pasteur Nice CHU; Hôpital de la Timone CHU - APHM TIMONE; CHU Trousseau Tours; Centre Hospitalier Universitaire d'Angers CHU Angers; Maternité Port-Royal CHU Cochin; Hôpital Haut-Lévêque CHU Bordeaux; Centre hospitalier universitaire de Poitiers = Poitiers University Hospital CHU de Poitiers; Hôpital Robert Debré; Institut de recherche en santé, environnement et travail Irset; École des Hautes Études en Santé Publique EHESP EHESP; Centre Hospitalier Saint Jean de Perpignan; Physiopathologie, Autoimmunité, maladies Neuromusculaires et THErapies Régénératrices PANTHER; CHU Saint-Antoine AP-HP; AP-HP - Hôpital Bichat - Claude Bernard Paris; Centre Hospitalier Universitaire CHU Grenoble CHUGA; Département de Médecine Interne et Pneumologie Brest DMIP - Brest; Hôpital Dupuytren CHU Limoges; Centre hospitalier Saint Joseph - Saint Luc Lyon; Hôpital Henri Mondor; Groupe Hospitalier du Havre Hôpital Jacques Monod (MONTIVILLIERS) GHH; Polyclinique Saint Laurent Rennes; Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286; CHU Pitié-Salpêtrière AP-HP; CHU Rouen; Service de médecine interne, médecine vasculaire et dermatologie Nord; AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre); Centre Hospitalier Universitaire de Nice CHU Nice; Centre Hospitalier Universitaire Strasbourg CHU Strasbourg; Centre de référence des maladies auto-immunes systémiques rares d'Île-de-France / National Reference Center for Rare Systemic Autoimmune Diseases; Hôpital Trousseau; Centre Hospitalier Universitaire de Bordeaux CHU de Bordeaux; Hôpital Hôtel-Dieu Paris; Hôpital Cochin AP-HP; Obstetrical, Perinatal and Pediatric Epidemiology |
| Publication Year: |
2024 |
| Collection: |
LillOA (Lille Open Archive - Université de Lille) |
| Description: |
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 |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
The Lancet Rheumatology; Lancet Rheumatol.; http://hdl.handle.net/20.500.12210/101252 |
| Availability: |
https://hdl.handle.net/20.500.12210/101252 |
| Rights: |
info:eu-repo/semantics/closedAccess |
| Accession Number: |
edsbas.8C150C05 |
| Database: |
BASE |