Pregnancy failure in patients with obstetric antiphospholipid syndrome with conventional treatment: the influence of a triple positive antibody profile

Lupus ◽  
2017 ◽  
Vol 26 (9) ◽  
pp. 983-988 ◽  
Author(s):  
J O Latino ◽  
S Udry ◽  
F M Aranda ◽  
S D A Perés Wingeyer ◽  
D S Fernández Romero ◽  
...  
Keyword(s):  
Risk Factors ◽  
Risk Factor ◽  
Antiphospholipid Syndrome ◽  
Pregnancy Outcomes ◽  
Conventional Treatment ◽  
Poor Response ◽  
Anticardiolipin Antibodies ◽  
History Of ◽  
Obstetric Antiphospholipid Syndrome ◽  
The Impact

Conventional treatment of obstetric antiphospholipid syndrome fails in approximately 20–30% of pregnant women without any clearly identified risk factor. It is important to identify risk factors that are associated with these treatment failures. This study aimed to assess the impact of risk factors on pregnancy outcomes in women with obstetric antiphospholipid syndrome treated with conventional treatment. We carefully retrospectively selected 106 pregnancies in women with obstetric antiphospholipid syndrome treated with heparin + aspirin. Pregnancy outcomes were evaluated according to the following associated risk factors: triple positivity profile, double positivity profile, single positivity profile, history of thrombosis, autoimmune disease, more than four pregnancy losses, and high titers of anticardiolipin antibodies and/or anti-βeta-2-glycoprotein-I (aβ2GPI) antibodies. To establish the association between pregnancy outcomes and risk factors, a single binary logistic regressions analysis was performed. Risk factors associated with pregnancy loss with conventional treatment were: the presence of triple positivity (OR = 5.0, CI = 1.4–16.9, p = 0.01), high titers of aβ2GPI (OR = 4.4, CI = 1.2–16.1, p = 0.023) and a history of more than four pregnancy losses (OR = 3.5, CI = 1.2–10.0, p = 0.018). The presence of triple positivity was an independent risk factor associated with gestational complications (OR = 4.1, CI = 1.2–13.9, p = 0.02). Our findings reinforce the idea that triple positivity is a categorical risk factor for poor response to conventional treatment.

Risk factors for early severe preeclampsia in obstetric antiphospholipid syndrome with conventional treatment. The impact of hydroxychloroquine

Lupus ◽  
2020 ◽  
Vol 29 (13) ◽  
pp. 1736-1742
Author(s):  
José Omar Latino ◽  
Sebastián Udry ◽  
Federico Aranda ◽  
Silvia Perés Wingeyer ◽  
Diego Santiago Fernández Romero ◽  
...  
Keyword(s):  
Risk Factors ◽  
High Risk ◽  
Antiphospholipid Syndrome ◽  
Conventional Treatment ◽  
Severe Preeclampsia ◽  
Factors Associated ◽  
High Risk Factors ◽  
History Of ◽  
Obstetric Antiphospholipid Syndrome ◽  
The Impact

Objective The first aim was to retrospectively identify risk factors for the development of early severe preeclampsia (sPE) in patients with obstetric antiphospholipid syndrome (OAPS) who received conventional treatment (CT). The second aim was to evaluate the impact of hydroxychloroquine (HCQ) in preventing early sPE among a subgroup of patients considered at high risk. Methods A total of 102 women diagnosed with OAPS and treated with CT since the diagnosis of pregnancy were selected. At the end of pregnancy, we identified risk factors associated with early sPE. According to these risk factors, we collected a new cohort of 42 patients who presented high-risk factors for developing early sPE and split them into two groups according to the treatment received: group A, CT (30 patients); and group B, CT+HCQ (12 patients). We evaluated and compared pregnancy outcomes in both groups. Results According to the multivariate analysis, risk factors associated with early sPE and CT were triple positivity for antiphospholipid antibodies (aPL) (OR = 24.70, [4.27–142.92], p < 0.001) and a history of early sPE (OR = 7.11, [1.13–44.64], p = 0.036). A low-risk aPL profile was associated with a good response to CT in preventing early sPE (OR = 0.073, [0.014–0.382], p = 0.002). High-risk patients treated with CT+HCQ had a significantly lower early sPE rate than those treated with CT only (8.3% vs 40.0%; p = 0.03). Conclusion Triple positivity for aPL and a history of early sPE are potential strong risk factors for the development of early sPE. HCQ might be an interesting therapeutic option for patients with high-risk factors for early sPE.

Stress, Cortisol and Suicide Risk

2019 ◽  
Author(s):  
Daryl Brian O'Connor
Keyword(s):  
Risk Factors ◽  
Suicidal Behavior ◽  
Suicide Risk ◽  
Stressful Events ◽  
Additional Risk ◽  
Global Health Issue ◽  
History Of ◽  
Hpa Axis Activity ◽  
The Impact

Suicide is a global health issue accounting for at least 800,000 deaths per annum. Numerous models have been proposed that differ in their emphasis on the role of psychological, social, psychiatric and neurobiological factors in explaining suicide risk. Central to many models is a stress-diathesis component which states that suicidal behavior is the result of an interaction between acutely stressful events and a susceptibility to suicidal behavior (a diathesis). This article presents an overview of studies that demonstrate that stress and dysregulated hypothalamic-pituitary-adrenal (HPA) axis activity, as measured by cortisol levels, are important additional risk factors for suicide. Evidence for other putative stress-related suicide risk factors including childhood trauma, impaired executive function, impulsivity and disrupted sleep are considered together with the impact of family history of suicide, perinatal and epigenetic influences on suicide risk.

scholarly journals Effect of tofogliflozin on arterial stiffness in patients with type 2 diabetes: prespecified sub-analysis of the prospective, randomized, open-label, parallel-group comparative UTOPIA trial

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Naoto Katakami ◽  
◽  
Tomoya Mita ◽  
Hidenori Yoshii ◽  
Toshihiko Shiraiwa ◽  
...  
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Conventional Treatment ◽  
Mixed Effects ◽  
Mixed Effects Models ◽  
Open Label ◽  
Parallel Group ◽  
History Of

Abstract Background Tofogliflozin, an SGLT2 inhibitor, is associated with favorable metabolic effects, including improved glycemic control and serum lipid profile and decreased body weight, visceral adipose tissue, and blood pressure (BP). This study evaluated the effects of tofogliflozin on the brachial-ankle pulse wave velocity (baPWV) in patients with type 2 diabetes (T2DM) without a history of apparent cardiovascular disease. Methods The using tofogliflozin for possible better intervention against atherosclerosis for type 2 diabetes patients (UTOPIA) trial is a prospective, randomized, open-label, multicenter, parallel-group, comparative study. As one of the prespecified secondary outcomes, changes in baPWV over 104 weeks were evaluated in 154 individuals (80 in the tofogliflozin group and 74 in the conventional treatment group) who completed baPWV measurement at baseline. Results In a mixed-effects model, the progression in the right, left, and mean baPWV over 104 weeks was significantly attenuated with tofogliflozin compared to that with conventional treatment (– 109.3 [– 184.3, – 34.3] (mean change [95% CI] cm/s, p = 0.005; – 98.3 [– 172.6, – 24.1] cm/s, p = 0.010; – 104.7 [– 177.0, – 32.4] cm/s, p = 0.005, respectively). Similar findings were obtained even after adjusting the mixed-effects models for traditional cardiovascular risk factors, including body mass index (BMI), glycated hemoglobin (HbA1c), total cholesterol, high-density lipoprotein (HDL)-cholesterol, triglyceride, systolic blood pressure (SBP), hypertension, smoking, and/or administration of drugs, including hypoglycemic agents, antihypertensive agents, statins, and anti-platelets, at baseline. The findings of the analysis of covariance (ANCOVA) models, which included the treatment group, baseline baPWV, and traditional cardiovascular risk factors, resembled those generated by the mixed-effects models. Conclusions Tofogliflozin significantly inhibited the increased baPWV in patients with T2DM without a history of apparent cardiovascular disease, suggesting that tofogliflozin suppressed the progression of arterial stiffness. Trial Registration UMIN000017607. Registered 18 May 2015. (https://www.umin.ac.jp/icdr/index.html)

scholarly journals Patients with SLE have higher risk of cardiovascular events and mortality in comparison with controls with the same levels of traditional risk factors and intima-media measures, which is related to accumulated disease damage and antiphospholipid syndrome: a case–control study over 10 years

2021 ◽  
Vol 8 (1) ◽  
pp. e000454
Author(s):  
Sofia Ajeganova ◽  
Ingiäld Hafström ◽  
Johan Frostegård
Keyword(s):  
Risk Factors ◽  
Antiphospholipid Syndrome ◽  
Carotid Plaque ◽  
Adverse Outcome ◽  
Density Lipoprotein ◽  
Index Score ◽  
Baseline Body Mass Index ◽  
Systemic Lupus ◽  
Increased Risk ◽  
History Of

ObjectiveSLE is a strong risk factor for premature cardiovascular (CV) disease and mortality. We investigated which factors could explain poor prognosis in SLE compared with controls.MethodsPatients with SLE and population controls without history of clinical CV events who performed carotid ultrasound examination were recruited for this study. The outcome was incident CV event and death. Event-free survival rates were compared using Kaplan-Meier curves. Relative HR (95% CI) was used to estimate risk of outcome.ResultsPatients (n=99, 87% female), aged 47 (13) years and with a disease duration of 12 (9) years, had mild disease at inclusion, Systemic Lupus Erythematosus Diseases Activity Index score of 3 (1–6) and Systemic Lupus International Collaborating Clinics (SLICC) Damage Index score of 0 (0–1). The controls (n=109, 91% female) were 49 (12) years old. Baseline carotid intima-media thickness (cIMT) did not differ between the groups, but plaques were more prevalent in patients (p=0.068). During 10.1 (9.8-10.2) years, 12 patients and 4 controls reached the outcome (p=0.022). Compared with the controls, the risk of the adverse outcome in patients increased threefold to fourfold taking into account age, gender, history of smoking and diabetes, family history of CV, baseline body mass index, waist circumference, C reactive protein, total cholesterol, high-density lipoprotein, low-density lipoprotein, dyslipidaemia, cIMT and presence of carotid plaque. In patients, higher SLICC score and SLE-antiphospholipid syndrome (SLE-APS) were associated with increased risk of the adverse outcome, with respective HRs of 1.66 (95% CI 1.20 to 2.28) and 9.08 (95% CI 2.71 to 30.5), as was cIMT with an HR of 1.006 (95% CI 1.002 to 1.01). The combination of SLICC and SLE-APS with cIMT significantly improved prediction of the adverse outcome (p<0.001).ConclusionIn patients with mild SLE of more than 10 years duration, there is a threefold to fourfold increased risk of CV events and death compared with persons who do not have SLE with similar pattern of traditional CV risk factors, cIMT and presence of carotid plaque. SLICC, SLE-APS and subclinical atherosclerosis may indicate a group at risk of worse outcome in SLE.

scholarly journals Estimating the burden of cardiovascular risk in community dwellers over 40 years old in South Africa, Kenya, Burkina Faso and Ghana

2021 ◽  
Vol 6 (1) ◽  
pp. e003499
Author(s):  
Ryan G Wagner ◽  
Nigel J Crowther ◽  
Lisa K Micklesfield ◽  
Palwende Romauld Boua ◽  
Engelbert A Nonterah ◽  
...  
Keyword(s):  
Risk Factors ◽  
Risk Factor ◽  
South African ◽  
Sub Saharan Africa ◽  
African Countries ◽  
Cvd Risk ◽  
Genomic Studies ◽  
Sub Saharan ◽  
Context Specific ◽  
The Impact

IntroductionCardiovascular disease (CVD) risk factors are increasing in sub-Saharan Africa. The impact of these risk factors on future CVD outcomes and burden is poorly understood. We examined the magnitude of modifiable risk factors, estimated future CVD risk and compared results between three commonly used 10-year CVD risk factor algorithms and their variants in four African countries.MethodsIn the Africa-Wits-INDEPTH partnership for Genomic studies (the AWI-Gen Study), 10 349 randomly sampled individuals aged 40–60 years from six sites participated in a survey, with blood pressure, blood glucose and lipid levels measured. Using these data, 10-year CVD risk estimates using Framingham, Globorisk and WHO-CVD and their office-based variants were generated. Differences in future CVD risk and results by algorithm are described using kappa and coefficients to examine agreement and correlations, respectively.ResultsThe 10-year CVD risk across all participants in all sites varied from 2.6% (95% CI: 1.6% to 4.1%) using the WHO-CVD lab algorithm to 6.5% (95% CI: 3.7% to 11.4%) using the Framingham office algorithm, with substantial differences in risk between sites. The highest risk was in South African settings (in urban Soweto: 8.9% (IQR: 5.3–15.3)). Agreement between algorithms was low to moderate (kappa from 0.03 to 0.55) and correlations ranged between 0.28 and 0.70. Depending on the algorithm used, those at high risk (defined as risk of 10-year CVD event >20%) who were under treatment for a modifiable risk factor ranged from 19.2% to 33.9%, with substantial variation by both sex and site.ConclusionThe African sites in this study are at different stages of an ongoing epidemiological transition as evidenced by both risk factor levels and estimated 10-year CVD risk. There is low correlation and disparate levels of population risk, predicted by different risk algorithms, within sites. Validating existing risk algorithms or designing context-specific 10-year CVD risk algorithms is essential for accurately defining population risk and targeting national policies and individual CVD treatment on the African continent.

Abstract O.13: Kawasaki disease in the Maghreb community in Quebec

Circulation ◽  
2015 ◽  
Vol 131 (suppl_2) ◽  
Author(s):  
Arbia A Gorrab ◽  
Asma Abed Bouaziz ◽  
Linda Spigelblatt ◽  
Anne Fournier ◽  
Nagib Dahdah
Keyword(s):  
Risk Factors ◽  
Coronary Artery Disease ◽  
Risk Factor ◽  
Kawasaki Disease ◽  
University Hospitals ◽  
Specific Population ◽  
History Of ◽  
Statistics Canada ◽  
Artery Disease ◽  
Children Under 5

Background: The real incidence of Kawasaki disease (KD) in the Maghreb countries (Morocco, Algeria, and Tunisia) is unknown. It is estimated low according to the literature. However, the number of Maghrebi children living in Quebec (Qc) affected by KD seems important. We sought to determine the incidence of KD among Maghrebi children in Qc, Canada, and to study its epidemiological and clinical features and to clarify possible risk factors related or superimposed to their immigration. Methods: A retrospective study of KD in Maghrebi children living in Qc (n=24) (1996-2013), compared to reports from Fes, Morocco (n=23) a doctoral thesis published in 2010 (2001-2009) and from Tunisia (n=31) collected in five university hospitals with four from the Great Tunis and one from Nabeul city (1996-2013). There are no reports available from Algeria. The “country of origin” specific population in the Province of Qc was obtained from Statistics Canada. Results: The annualized incidence rate (AIR) of KD among Maghrebi children in Qc was 9.58/100,000 children under 5 years(Standard-Denominator (SD)).This is 6 times higher in Qc (5.57/SD and 19.02/SD among Tunisian and Moroccan descents) vs Tunisia (Nabeul Governorate) and Morocco (Fes) (0.95/SD and 3.15/SD). Personal and family history of allergy were significantly higher in Qc 42% (10/24) and 75% (18/24), respectively, whereas these features were reported near 0% in both reports from Morocco and Tunisia. The prevalence of incomplete KD criteria was relatively high in the 3 series 46% (11/24) in Qc vs 43% (10/23) and 35% (11/31); (p=NS). Diagnosis was late (gt day 10 of fever) in 1/24(4%) in Qc vs 7/23 (30%) in Morocco and 11/31 (35%) in Tunisia; (p 0.01). IVIG were administered in the acute phase to all patients in Qc, 5/23 in Morocco and 28/31 in Tunisia. However coronary complications were more common in Qc 42% (10/24) vs 22% (5/23) vs 19% (6/31) (p=0.02). Aneurysms were significantly associated with the incomplete form in the 3 groups (p=0.01). Conclusions: The observed AIR of KD in the Maghreb community in Qc is higher than the countries of origin where underdiagnosis is possible. Atopy may still be a risk factor in Qc. The coronary artery disease seems linked not only to therapeutic delay but also to the underlying terrain.

Abstract T P136: Potential Contributors to the Declining Impact of Stroke Risk Factors with Age: Implications for Stroke Epidemiology in the Elderly

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
George Howard ◽  
Mary Cushman ◽  
Maciej Banach ◽  
Brett M Kissela ◽  
David C Goff ◽  
...  
Keyword(s):  
Risk Factors ◽  
Risk Factor ◽  
Stroke Risk ◽  
Multivariable Analysis ◽  
The Elderly ◽  
Stroke Risk Factors ◽  
Age Related ◽  
Increased Risk ◽  
The Impact ◽  
Age Related Changes

Purpose: The importance of stroke research in the elderly is increasing as America is “graying.” For most risk factors for most diseases (including stroke), the magnitude of association with incident events decreases at older ages. Potential changes in the impact of risk factors could be a “true” effect, or could be due to methodological issues such as age-related changes in residual confounding. Methods: REGARDS followed 27,748 stroke-free participants age 45 and over for an average of 5.3 years, during which 715 incident strokes occurred. The association of the “Framingham” risk factors (hypertension [HTN], diabetes, smoking, AFib, LVH and heart disease) with incident stroke risk was assessed in age strata of 45-64 (Young), 65-74 (Middle), and 75+ (Old). For those with and without an “index” risk factor (e.g., HTN), the average number of “other” risk factors was calculated. Results: With the exception of AFib, there was a monotonic decrease in the magnitude of the impact across the age strata, with HTN, diabetes, smoking and LVH even becoming non-significant in the elderly (Figure 1). However, for most factors, the increasing prevalence of other risk factors with age impacts primarily those with the index risk factor absent (Figure 2, example HTN as the “index” risk factor). Discussion: The impact of stroke risk factors substantially declined at older ages. However, this decrease is partially attributable to increases in the prevalence of other risk factors among those without the index risk factor, as there was little change in the prevalence of other risk factors in those with the index risk factor. Hence, the impact of the index risk factor is attenuated by increased risk in the comparison group. If this phenomenon is active with latent risk factors, estimates from multivariable analysis will also decrease with age. A deeper understanding of age-related changes in the impact of risk factors is needed.

Features of the medical history and pregnancy outcomes in women with antiphospholipid syndrome depending on correction methods

2020 ◽  
Vol 69 (2) ◽  
pp. 23-32
Author(s):  
Elena N. Kravchenko ◽  
Anastasia A. Goncharova ◽  
Larisa V. Kuklina
Keyword(s):  
Cohort Study ◽  
Medical History ◽  
Antiphospholipid Syndrome ◽  
Pregnancy Outcomes ◽  
Antiphospholipid Antibodies ◽  
Optimal Choice ◽  
Not Given ◽  
Group I ◽  
History Of ◽  
Torch Infection

Hypothesis/aims of study. The aim of this study was to evaluate the features of the medical history and pregnancy outcomes in women with miscarriage and antiphospholipid syndrome depending on the methods of its correction. Study design, materials and methods. A prospective cohort study was conducted, in which a total of 137 pregnant women with a history of abortion and antiphospholipid syndrome were examined. The women were divided into two groups according to the principle of the presence or absence of plasmapheresis procedures in the scheme of miscarriage therapy at the pregravid stage. Group I (main) consisted of individuals (n = 73), who were treated with the inclusion of plasmapheresis at the pregravid stage; group II (comparison) included women (n = 64), who were not given efferent therapy. Results. Antiphospholipid syndrome was more common in patients with a complicated obstetric and gynecological history. As a result of persistent infection, chronic endometritis and salpingo-ooparitis were more often observed in patients with TORCH infection. The titer of antiphospholipid antibodies, regardless of the presence or absence of TORCH infection, decreased after plasmapheresis, such positive dynamics being observed only in patients with a history of gestational losses of less than four. Conclusion. The level of reduction of antiphospholipid antibodies in relation to the initial values was 6095%, which indicates the optimal choice of the characteristics of plasmapheresis therapy and its duration.

Abstract P676: Rates of Preventable Thrombectomy in Acute Ischemic Stroke

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Rakhee Lalla ◽  
Ryan Dunlow ◽  
Karen L Yarbrough ◽  
Prachi Mehndiratta ◽  
Michael S Phipps ◽  
...  
Keyword(s):  
Risk Factors ◽  
Risk Factor ◽  
Vascular Disease ◽  
Antiplatelet Agent ◽  
Left Ventricular ◽  
Vascular Risk Factors ◽  
Large Vessel ◽  
Favorable Outcome ◽  
Vascular Risk ◽  
History Of

Introduction: The AHA notes that more than 76% of strokes are the first occurrence. There are class 1 recommendations for the management of common risk factors such as atrial fibrillation (AF), hyperlipidemia (HLD), hypertension (HTN), diabetes (DM), and vascular disease. The purpose of this study is to investigate the percentage of large vessel strokes that are potentially preventable with adequate management of vascular risk factors. Methods: A retrospective chart review was conducted on all patients undergoing endovascular therapy (EVT) from 2012-2019. Data was collected on vascular risk factors present prior to admission including HTN, DM, HLD, AF, and smoking. Preventable stroke was defined as having at least one of the following: untreated AF, untreated HLD, poorly controlled HTN (presence of left ventricular hypertrophy on transthoracic echo), history of vascular disease not on an antiplatelet agent, poorly controlled DM (A1c>10), current smoking. Groups were compared based on age, sex and 90 day functional outcomes, with favorable outcome defined as mRS ≤ 2. Results: Our sample included 396 patients who underwent EVT (mean age 65, 50% female). 42% of patients with Afib were not on anticoagulation, 31% of patients with HLD were untreated, 39% of patients with HTN were poorly controlled, 27% of patients with a history of vascular disease were not on an antiplatelet, 14% of patients with DM were poorly controlled, and 46% of all patients were smokers. In total, 78% of patients had at least 1 poorly controlled risk factor and 37% had at least 2. There was no difference in rates of preventable stroke between males and females (48% vs 52%, p=0.30) and between age groups above and below 70 (40% vs 60%, p=0.68). 64% of patients with well controlled risk factors had a favorable outcome compared to 51% with at least one poorly controlled risk factor (p=0.03). Conclusions: Our data suggests that despite guidelines on management of vascular risk factors, a large number of these are poorly controlled prior to admission for large vessel stroke, leading to a potentially preventable procedure. Not only could improved primary prevention save the wide array of resources utilized in EVT, but it could also influence long term outcomes in this cohort of patients.

Bleeding complications and antithrombotic treatment in 264 pregnancies in antiphospholipid syndrome

Lupus ◽  
2018 ◽  
Vol 27 (10) ◽  
pp. 1679-1686 ◽  
Author(s):  
C M Yelnik ◽  
M Lambert ◽  
E Drumez ◽  
V Le Guern ◽  
J-L Bacri ◽  
...  
Keyword(s):  
Antiphospholipid Syndrome ◽  
Major Bleeding ◽  
Pregnancy Outcomes ◽  
Prospective Cohort ◽  
Retrospective Cohort ◽  
Post Partum ◽  
Bleeding Complications ◽  
Minor Bleeding ◽  
Increased Risk ◽  
History Of

Purpose The purpose of this study was to evaluate the safety of antithrombotic treatments prescribed during pregnancy in patients with antiphospholipid syndrome (APS). Methods This international, multicenter study included two cohorts of patients: a retrospective French cohort and a prospective US cohort (PROMISSE study). Inclusion criteria were (1) APS (Sydney criteria), (2) live pregnancy at 12 weeks of gestation (WG) with (3) follow-up data until six weeks post-partum. According to APS standard of care, patients were treated with aspirin and/or low-molecular weight heparin (LMWH) at prophylactic (pure obstetric APS) or therapeutic doses (history of thrombosis). Major bleeding was defined as abnormal blood loss during the pregnancy and/or post-partum period requiring intervention for hemostasis or transfusion, or during the peripartum period greater than 500 mL and/or requiring surgery or transfusion. Other bleeding events were classified as minor. Results Two hundred and sixty-four pregnancies (87 prospectively collected) in 204 patients were included (46% with history of thrombosis, 23% with associated systemic lupus). During pregnancy, treatment included LMWH ( n = 253; 96%) or low-dose aspirin ( n = 223; 84%), and 215 (81%) patients received both therapies. The live birth rate was 89% and 82% in the retrospective and prospective cohorts, respectively. Adverse pregnancy outcomes occurred in 28% of the retrospective cohort and in 40% of the prospective cohort. No maternal death was observed in either cohort. A combined total of 45 hemorrhagic events (25%) occurred in the retrospective cohort, but major bleeding was reported in only six pregnancies (3%). Neither heparin nor aspirin alone nor combined therapy increased the risk of hemorrhage. We also did not observe an increased rate of bleeding in the case of a short interval between last LMWH (less than 24 hours) or aspirin (less than five days) doses and delivery. Only emergency Caesarean section was significantly associated with an increased risk of bleeding (odds ratio (OR) 5.03 (1.41–17.96); p=.016). In the prospective cohort, only one minor bleeding event was reported (vaginal bleeding). Conclusion Our findings support the safety of antithrombotic therapy with aspirin and/or LMWH during pregnancy in high-risk women with APS, and highlight the need for better treatments to improve pregnancy outcomes in APS. PROMISSE Study ClinicalTrials.gov identifier: NCT00198068.

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