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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)

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ClinicalTrials.gov Identifier: NCT02833194
Recruitment Status : Completed
First Posted : July 14, 2016
Last Update Posted : July 14, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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).

Condition or disease
Antiphospholipid Syndrome Factor V Leiden Thrombophilia

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Study Type : Observational
Actual Enrollment : 1592 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : July 2005
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015


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.



Primary Outcome Measures :
  1. Mini Internationl Neuropsychiatric Interview 5.0.0 [ Time Frame: 10 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02833194


Locations
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France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Jean-Christophe Gris, MD, PhD Centre Hospitalier Universitaire de Nîmes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02833194     History of Changes
Other Study ID Numbers: LOCAL/2015/JCG-01
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
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Syndrome
Mental Disorders
Problem Behavior
Antiphospholipid Syndrome
Thrombophilia
Activated Protein C Resistance
Disease
Pathologic Processes
Behavioral Symptoms
Autoimmune Diseases
Immune System Diseases
Hematologic Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Coagulation Protein Disorders
Genetic Diseases, Inborn