RecruitingNot ApplicableNCT06297252

Prevalence of Psychiatric Disorders During Pregnancy at 2nd Trimester Ultrasound: a Feasibility Study in the General Population


Sponsor

University Hospital, Montpellier

Enrollment

140 participants

Start Date

Apr 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Young women represent a population at risk of psychiatric disorders, the first signs of which often appear between the ages of 15 and 25. Psychiatric disorders are a major source of disability and healthcare costs. The perinatal period is an additional period of psychological vulnerability, during which women are at increased risk of developing or worsening psychiatric disorders. Unfortunately, psychiatric disorders seem to be largely under-diagnosed during this period, and therefore under-treated. The goal of this Prospective multicenter study is to determine the prevalence of the presence of at least one characterized psychiatric disorder, as defined by the use of the Mini International Neuropsychiatric Interview (MINI), in remission or not, during pregnancy, at the time of the second-trimester ultrasound (T2 ultrasound) based on a standardized clinical assessment. Participants will complete self-questionnaires and have a standardized psychiatric evaluation at T2 ultrasound and at 2 months postpartum.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

  • Women
  • years and over
  • Pregnant and consulting for scheduled second trimester ultrasound
  • Able to read and write with a good knowledge of French

Exclusion Criteria8

  • Unable to understand French
  • Illiterate
  • Underage patient at time of second trimester ultrasound
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient not affiliated to or not benefiting from a social security scheme
  • Refusal of consent after information
  • Participant in another research project with an ongoing exclusion period

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Interventions

DIAGNOSTIC_TESTstandardized clinical psychiatric evaluations

The intervention consists of a psychiatric consultation including : * assessment of psychiatric disorders using a MINI test * information gathering (medical, obstetrical and family history, expected term of pregnancy). * assessment of suicidal behaviour using the Columbia-Suicide Severity Rating Scale (CSSR-S) * collection of negative life events over the past 12 months, assessed using the Paykel questionnaire

DIAGNOSTIC_TESTself-administered psychiatric questionnaire assessments

* EPICES Score: (Evaluation de la Précarité et des Inégalités de santé dans les Centres d'Examens de Santé): * MIBS: (Mother to Infant Bonding Scale) * PAI: (Prenatal Attachment Inventory) * EDEQ: (Eating Disorder Examination Questionnaire) * PCL-5: (Post-traumatic Stress Disorder Checklist for DSM-V) * MARS: (Medication Adherence Rating Scale) * EPDS: (Edinburgh Postnatal Depression Scale)

OTHERblood sampling

A blood sample is taken to form an optional biological collection, comprising 3 samples: * A tube to collect RNA from whole blood. * A tube to collect serum * A tube to collect native DNA


Locations(2)

Centre Hospitalier de Béziers

Béziers, France

University Hospital of Montpellier

Montpellier, France

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NCT06297252


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