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

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