Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome

NCT01649479 | Terminated

• 2 other identifiers: PHRC-I/2012/FC-012012-A00705-38
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

Brief Summary

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).

Conditions

Antiphospholipid Syndrome

Keywords

Obstetrical antiphospholipid syndrome; Thrombophilia

Outcome Measures

Primary Outcomes (1)

• presence/absence of (lifetime) psychiatric symptoms

  The Mini International Neuropsychiatric Interview (MINI 6) will be used to determined the presence/absence of (lifetime) psychiatric symptoms.

  baseline (transversal); Day 0

Secondary Outcomes (18)

• 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

Study Arms (3)

Suspected Obstetrical APS; confirmed APS

OTHER

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

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

Sus. Obst. APS, confirmed thrombophilia

OTHER

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

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

Suspected Obstectrical APS; unconfirmed

OTHER

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

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

Interventions

Antiphospholipid antibody tests BIOLOGICAL

Each patient will be tested for antiphospholipid antibodies.

Sus. Obst. APS, confirmed thrombophilia; Suspected Obstectrical APS; unconfirmed; Suspected Obstetrical APS; confirmed APS

Thrombophilia bloodwork BIOLOGICAL

Bloodwork will be drawn up for: * antithrombin, protein C, protein S * Factor V Leiden polymorphisms (F5 1691A) * prothrombin 20210A gene polymorphism (F2 20210A) * JAK2 617F Mutation * Homocysteine * Factor VIII

Sus. Obst. APS, confirmed thrombophilia; Suspected Obstectrical APS; unconfirmed; Suspected Obstetrical APS; confirmed APS

Psychiatric evaluation OTHER

During this consultation, the Mini International Neuropsychiatric Interview will be used to screen for psychiatric symptoms. Should the latter be detected, a further consult with a psychiatrist or a psychologist will be organized; this second consult will include the Mood Disorder Questionnaire (MDQ), the Beck Depression Inventory (BDI), the Inventory for Depressive Symptomatology - Clinician (IDS-C) and the Structured Clinical Interview for Disorders (SCID, DSM-IV).

Sus. Obst. APS, confirmed thrombophilia; Suspected Obstectrical APS; unconfirmed; Suspected Obstetrical APS; confirmed APS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (5)

APHM - Hôpital de la Conception

Marseille, 13385, France

Location

APHM - Hôpital La Timone Adultes

Marseille, 13385, France

Location

APHM - Hôpital Nord

Marseille, 13915, France

Location

CHU de Montpellier - Hôpital Saint-Eloi

Montpellier, 34295, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Antiphospholipid Syndrome; Thrombophilia

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 25, 2012
• Study Start: April 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

FR (5)