NCT01649479终止不适用
Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome
Centre Hospitalier Universitaire de Nīmes10 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 10
- 主要终点
- presence/absence of (lifetime) psychiatric symptoms
研究概览
简要总结
The main objective of this study is to estimate the lifetime prevalence of major psychiatric disorders (axis I DSM-IV; Diagnostic and Statistical Manual of Mental Disorders, version IV) in a large sample of patients with developed clinical signs of pure obstetrical antiphospholipid syndrome (suspected APS).
详细描述
The secondary objectives of this study are:
A. To compare the lifetime prevalence of these major disorders between groups;
B. To assess the association of different, targeted, qualitative biomarkers with clinical symptomatology;
C. To assess the association between the presence of "transitory APS" and the presence of psychiatric disorders;
D. Estimate and compare the current prevalence (= the day of assessment) of major psychiatric disorders in the sample of patients who developed clinical signs of obstetrical APS;
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •Not postmenopausal
- •Able to understand the nature, purpose and methodology of the study and agreed to cooperate in clinical and biological assessments
- •Available for 12 weeks of follow-up
- •Isolated obstetric morbidity, defined by at least one of the following criteria:
- •at least three consecutive episodes of unexplained, early, embryonic miscarriage, which occurred before the 10th week of pregnancy, with normal maternal anatomic and hormonal assessment, normal karyotypes for both biological parents;
- •at least one unexplained fetal death, defined as occurring after the 10th week of pregnancy, involving a morphologically normal fetus as documented by ultrasound examination or direct examination of the conceptus;
- •at least one premature birth of a morphologically normal fetus before the 34th week of pregnancy, because of: (1) pre-eclampsia, severe or not, according to the American College of Obstetrics and Gynecology, ACOG, 2002; (2)documented placental insufficiency, defined by the following parameters: (2a) abnormal or non-reassuring fetal monitoring exam, in general a non-reactive absence-of-fetal-stress test (fetal monitoring), suggesting fetal hypoxemia; (2b) a Doppler examination of uterine arteries suggesting fetal hypoxemia, ie the absence of end-diastolic flow in the umbilical arteries; (2c) oligohydramnios, that is to say, an amniotic flow index <5 cm; (2d) indexed birth weight for gestational age and sex below the 10th percentile.
- •Patient willing to accept psychological and medical care over the long term
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient or breastfeeding
- •Systemic vascular morbidity, defined by the following criteria: (1) Any personal history of venous thromboembolism, defined by the occurrence of deep phlebitis and / or a pulmonary embolism, diagnosed by means of objective exploration ; (2)Any personal history of superficial venous thrombosis; (3) Any personal history of clinical, symptomatic relapses of arterial insufficiency - the latter may be cerebro vascular in nature (transient ischemic attack, stroke, etc..), coronary in nature (angina, myocardial infarction, etc..) or otherwise (claudication mesenteric, etc.), and objectively diagnosed.
- •Systemic inflammatory disease: any history of systemic disease, lupus erythematosus or other connective, rheumatoid arthritis
- •Any history of neoplastic disease
- •Chronic antithrombotic treatment taken before the occurrence of obstetrical complications
- •Any chronic immunosuppressive therapy or immunomodulatory therapy (eg corticosteroids, hydroxochloroquine or intravenous immunoglobulins)
- •Fetal loss can be explained by infectious, metabolic (including rates of fasting blood glucose> 7 mmol / L), anatomical or hormonal factors
- •History of infection with hepatitis B, hepatitis C or HIV
- •Taking antipsychotic treatment potentially implicated in biological autoimmune abnormalities
结局指标
主要结局
presence/absence of (lifetime) psychiatric symptoms
时间窗: baseline (transversal); Day 0
The Mini International Neuropsychiatric Interview (MINI 6) will be used to determined the presence/absence of (lifetime) psychiatric symptoms.
次要结局
- presence/absence of (current) psychiatric symptoms(baseline (transversal); Day 0)
- SCID-1 score(baseline (transversal); Day 0 or up to Day 15)
- MDQ score(baseline (transversal); Day 0)
- BDI score(baseline (transversal); Day 0 or up to Day 15)
- IDS-C score(baseline (transversal); Day 0 or up Day 15)
- presence/absence of lupus anticoagulant(baseline (transversal); Day 0)
- presence/absence of anticardiolipid antibodies(baseline (transversal); Day 0)
- presence/absence of anti-beta2-glycoprotein 1 antibodies(baseline (transversal); Day 0)
- deficit in antithrombin: yes/no(baseline (transversal); Day 0)
- Deficit in protein C: yes/no(baseline (transversal); Day 0)
- Deficit in protein S: yes/no(baseline (transversal); Day 0)
- Excess of FVIII: yes/no(baseline (transversal); Day 0)
- Excess of homocystein? yes/no(baseline (transversal); Day 0)
- presence/absence of allele F5 1691A(baseline (transversal); Day 0)
- presence/absence of allele F2 20210A(baseline (transversal); Day 0)
- presence/absence of allele JAK2 617F(baseline (transversal); Day 0)
- Age at beginning of psychiatric symptoms(baseline (transversal); Day 0)
- Age at beginning of APL or thrombophilia symptoms(baseline (transversal); Day 0)
研究者
研究点 (10)
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