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

NCT02833194 | Completed

• 1 other identifier: LOCAL/2015/JCG-01
• Study Type: observational
• Target: 1,592
• Locations: 1 country
• Sites: 1

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).

Conditions

Antiphospholipid Syndrome; Factor V Leiden Thrombophilia

Outcome Measures

Primary Outcomes (1)

• Mini Internationl Neuropsychiatric Interview 5.0.0

  10 years

Study Arms (3)

Leiden Group

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

aP1Ab-positive

Inclusion in the "aP1Ab" Group: * Initially positive for aP1Ab * Second positive aP1Ab test six months later

Thrombophilia-negative

Women with completely negative thombophilia screening results.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were selected via the regional NOHA (Nîmes Obstetricians and Hematologists - Antiphospholipid Syndrome study) network, which referred women with losses of spontaneous pregnancies to the Hematology Outpatient Department of the Nîmes University Hospital.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

• Gris JC, Cyprien F, Bouvier S, Cochery-Nouvellon E, Lavigne-Lissalde G, Mercier E, Balducchi JP. Antiphospholipid antibodies are associated with positive screening for common mental disorders in women with previous pregnancy loss. The NOHA-PSY observational study. World J Biol Psychiatry. 2019 Jan;20(1):51-63. doi: 10.1080/15622975.2017.1333146. Epub 2017 Jun 19.

  PMID: 28532221 RESULT

MeSH Terms

Conditions

Antiphospholipid Syndrome; Thrombophilia due to Activated Protein C Resistance

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Study Officials

• Jean-Christophe Gris, MD, PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 14, 2016
• Study Start: July 1, 2005
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: November 21, 2025

Record last verified: 2023-06

Locations

FR (1)