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

Centre Hospitalier Universitaire de Nīmes1 site in 1 country1,592 target enrollmentJuly 1, 2005

ConditionsAntiphospholipid Syndrome Factor V Leiden Thrombophilia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Antiphospholipid Syndrome
Sponsor: Centre Hospitalier Universitaire de Nīmes
Enrollment: 1592
Locations: 1
Primary Endpoint: Mini Internationl Neuropsychiatric Interview 5.0.0
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

July 1, 2005

End Date

December 31, 2018

Last Updated

5 months ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

Eligibility Criteria

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.