Assessment of the Prevalence of Major Psychiatric Disorders in a Cohort of Women With Clinical Criteria Corresponding to Pure, Abortive-form, Obstetrical, Antiphospholipid Syndrome (NOHA-PSY)

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Antiphospholipid Syndrome

Factor V Leiden Thrombophilia

Study type

Observational

Funder types

Other

Identifiers

NCT02833194

LOCAL/2015/JCG-01

Details and patient eligibility

About

The primary objective of this study was to evaluate and compare the prevalence of the following psychiatric pathologies (based on the MINI5.0.0 questionnaire) among 3 groups of women (Leiden versus aP1Ab-positive versus thrombophilia-negative) with similar obstetrical histories 10 years after their initial assessment/diagnosis.

Mood disorders, including depressive episodes during the previous two weeks, recurrent depressive disorders at any point in life, dysthymia in the last two years, or any current or past manic episode;
Anxiety disorders, including current agoraphobia, current panic disorders, agoraphobia with panic disorders, current social phobia, generalized anxiety in the last 6 months, or current posttraumatic stress syndrome;
Apparent psychotic syndromes, including isolated or recurrent psychotic syndromes, past or present (clinically validated),
Current alcohol or drug problems (dependence or abuse).

Enrollment

1,592 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

Three unexplained consecutive spontaneous abortions before the 10th week of gestation (the recurrent embryo loss subgroup) - OR -
One unexplained death of a morphologically normal fetus (fetal loss) at or after the 10th week of gestation (fetal loss subgroup).

Exclusion criteria

Any history of thrombotic events or any treatment given during previous pregnancies that might have modified the natural course of the condition
Women whose pregnancy losses could be explained by infectious, metabolic, anatomic or hormonal facotrs, or associated with paternal or maternal chromosomal causes
Seropositivity for HIV, hepatitis B or C
Women with antithrombin, protein C, or protein S deficiency, and women with abnormal fibrinogen or with the JAK2 V617F mutation were further excluded.