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

June 5, 2023 updated by: Centre Hospitalier Universitaire de Nīmes

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1592

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes Cedex 09, France, 30029
        • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mini Internationl Neuropsychiatric Interview 5.0.0
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Jean-Christophe Gris, MD, PhD, Centre Hospitalier Universitaire de Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimated)

July 14, 2016

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOCAL/2015/JCG-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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