Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Prognostic Value of PGF and sFlt1 Variations Induced by the First Low-molecular-weight-heparin Injections in Women With Obstetrical Antiphospholipids Antibody Syndrome Starting a New Pregnancy and Following Treatment in Accordance With International Recommendations

NCT02855047

Antiphospholipid Syndrome

COMPLETED

Evaluation of the Incidence of Cancer in the Follow-up of Women With 3 Consecutive Embryonic Demises Before 10 Weeks or 1 Fetal Death, According to Their Thrombophilia Status, With a Special Focus on Women With an Obstetric Antiphospholipid Symdrome (oAPS)

NCT03969498

Antiphospholipid Syndrome Pregnancy Related Cancer

COMPLETED

Obstetric Antiphospholipid Antibody Syndrome : Contribution of the Evaluation of ADAMTS13 Made at the Diagnosis of Pregnancy on Evaluation the Risk of Pre-eclampsia

NCT04319341

Antiphospholipid Antibody Syndrome in Pregnancy

COMPLETED

Antiphospholipid Syndrome and Postpartum Pulmonary Artery Pressure

NCT05679206

Pre-Eclampsia; Complicating Pregnancy Antiphospholipid Syndrome in Pregnancy Pulmonary Hypertension

RECRUITING

Medium-term Follow-up of Patients With Obstetric Antiphospholipid Syndrome: MRI Study of White Matter

NCT03600636

Antiphospholipid Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Antiphospholipid Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Suspected Obstetrical APS; confirmed APS

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

Group Type OTHER

Antiphospholipid antibody tests

Intervention Type BIOLOGICAL

Each patient will be tested for antiphospholipid antibodies.

Thrombophilia bloodwork

Intervention Type 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

Psychiatric evaluation

Intervention Type 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

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

Group Type OTHER

Antiphospholipid antibody tests

Intervention Type BIOLOGICAL

Each patient will be tested for antiphospholipid antibodies.

Thrombophilia bloodwork

Intervention Type 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

Psychiatric evaluation

Intervention Type 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).

Suspected Obstectrical APS; unconfirmed

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

Group Type OTHER

Antiphospholipid antibody tests

Intervention Type BIOLOGICAL

Each patient will be tested for antiphospholipid antibodies.

Thrombophilia bloodwork

Intervention Type 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

Psychiatric evaluation

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Antiphospholipid antibody tests

Each patient will be tested for antiphospholipid antibodies.

Intervention Type BIOLOGICAL

Thrombophilia bloodwork

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

Intervention Type BIOLOGICAL

Psychiatric evaluation

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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No