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

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Recruitment Status

COMPLETED

Total Enrollment

1592 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2018-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Antiphospholipid Syndrome Factor V Leiden Thrombophilia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Leiden Group

Women with an isolated F5 rs6025 polymorphism or an isolated F2 rs1799963 polymorphism.

No interventions assigned to this group

aP1Ab-positive

Inclusion in the "aP1Ab" Group:

* Initially positive for aP1Ab
* Second positive aP1Ab test six months later

No interventions assigned to this group

Thrombophilia-negative

Women with completely negative thombophilia screening results.

No interventions assigned to this group

Eligibility Criteria

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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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No