Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome (MENT-APL-O)

Centre Hospitalier Universitaire de Nīmes

Status: Terminated

Conditions: Antiphospholipid Syndrome

Treatments: Other: Psychiatric evaluation; Biological: Antiphospholipid antibody tests; Biological: Thrombophilia bloodwork

Study type: Interventional

Funder types: Other

Identifiers

NCT01649479

2012-A00705-38 (Other Identifier)

PHRC-I/2012/FC-01

Details and patient eligibility

About

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).

Full description

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;

E. Estimate the current prevalence (= the day of assessment) and intensity of major depressive episodes (MDE) in the sample of patients;

F. Compare the prevalence of current MDE and the intensity of depressive symptoms present between groups;

G. Estimate and compare the (lifetime and current) prevalence by category of psychiatric disorders (psychotic, anxiety, mood, etc..) in the APS group with that in the thrombophilic group and the remaining group;

H. To study the average age of onset of psychiatric disorders and clinical manifestations of APS in the sample of patients who developed clinical signs of obstetrical APS;

I. Compare the mean ages between groups;

J. Compare the mean age at onset of psychiatric disorders with the average age of the first clinical manifestation of the disease in the group of women with APS.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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20 participants in 3 patient groups

Suspected Obstetrical APS; confirmed APS

Other group

Description:

The patients included in this study are women actively addressed to the participating departments because of clinical symptoms corresponding to suspected obstetrical anti-phospholipid syndrome. Bloodwork later confirms that these patients have APS. All patients included in this study will have the following interventions: * antiphospholipid antibody tests * thrombophilia bloodwork * psychiatric evaluation

Treatment:

Biological: Antiphospholipid antibody tests

Other: Psychiatric evaluation

Biological: Thrombophilia bloodwork

Sus. Obst. APS, confirmed thrombophilia

Other group

Description:

The patients included in this study are women actively addressed to the participating departments because of clinical symptoms corresponding to suspected obstetrical anti-phospholipid syndrome. Bloodwork later confirms that these patients are thrombophilic. All patients included in this study will have the following interventions: * antiphospholipid antibody tests * thrombophilia bloodwork * psychiatric evaluation

Treatment:

Biological: Antiphospholipid antibody tests

Other: Psychiatric evaluation

Biological: Thrombophilia bloodwork

Suspected Obstectrical APS; unconfirmed

Other group

Description:

The patients included in this study are women actively addressed to the participating departments because of clinical symptoms corresponding to suspected obstetrical anti-phospholipid syndrome. Bloodwork cannot confirm APS, nor thrombophilia. All patients included in this study will have the following interventions: * antiphospholipid antibody tests * thrombophilia bloodwork * psychiatric evaluation

Treatment:

Biological: Antiphospholipid antibody tests

Other: Psychiatric evaluation

Biological: Thrombophilia bloodwork