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

Antiphospholipid Syndrome Clinical Trial

— NOHA-PSY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02833194
• Other study ID #: LOCAL/2015/JCG-01
• Status: Completed
• Start date: July 2005
• Est. completion date: July 2015

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1592
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Antiphospholipid Syndrome
• Factor V Leiden Thrombophilia
• Mental Disorders
• Problem Behavior
• Syndrome
• Thrombophilia

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini Internationl Neuropsychiatric Interview 5.0.0		10 years