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Completed

NCT Number: NCT02833194

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

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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Key information

Conditions

Antiphospholipid Syndrome Autoimmune Diseases Factor V Leiden Thrombophilia Immune System Diseases Thrombophilia due to Activated Protein C Resistance

Sex eligibility

Female

Study type

Observational

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mini Internationl Neuropsychiatric Interview 5.0.0

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: NOHA-PSY

Important dates

Study start
2005
Primary completion
2018
Study completion
2018
First posted
Jul 14, 2016
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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