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

NCT06297252 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2024-05-06

No results posted yet for this study

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.

Conditions

  • Pregnancy

Interventions

DIAGNOSTIC_TEST

standardized 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_TEST

self-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)

OTHER

blood 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

Sponsors & Collaborators

  • Beziers Hospital

    collaborator OTHER
  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Raoul Belzeaux, MD PhD · University Hospital, Montpellier

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-25
Primary Completion
2026-04-24
Completion
2026-10-24

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06297252 on ClinicalTrials.gov