NCT06297252

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. They are often comorbid, and can be complicated by suicidal behaviour. Delays in diagnosis are common, significantly worsening the prognosis and increasing the societal cost of these disorders. The perinatal period is an additional period of psychological vulnerability, during which women are at increased risk of developing or worsening psychiatric disorders. Unfortunately, these disorders seem to be largely under-diagnosed during this period, and therefore under-treated. To date, psychiatric diagnoses are exclusively clinical. They can be facilitated by screening questionnaires, the sensitivity and specificity of which are highly heterogeneous and sometimes poorly understood in the perinatal period and in the general population of pregnant women. What's more, several studies have shown that clinical diagnosis in everyday practice often lacks sensitivity when compared with standardized assessments, i.e. those based on a structured and reproducible diagnostic approach, which is longer and more costly, such as the MINI (Mini International Neuropsychiatric Interview). The state of knowledge on the epidemiology of psychiatric disorders in the perinatal period suffers from many imperfections. The vast majority of studies focus exclusively on postpartum depression. This project, on the other hand, focuses on the diagnosis of any psychiatric disorder characterized by a standardized diagnostic interview (validated and reproducible, like the MINI) carried out by a professional trained in the clinical management of psychiatric disorders. Biomarkers, in particular to aid differential diagnosis, are being developed and are a source of hope for improving the quality of screening; but the results are rarely replicated in independent cohorts or from biological banks associated with quality clinical data. Our hypothesis is that the prevalence of psychiatric disorders (current or in remission), in this population, is at least 20% and that more than half of these disorders are unknown. From a practical point of view, it aims to improve assessments of psychiatric vulnerabilities within the two main public maternity hospitals in the Hérault department in France. From a scientific point of view, it will provide an opportunity to create a highly original bank of biological samples, opening up interesting research prospects in psychiatry, but also well beyond, given the specific nature of the population concerned.

Conditions

• Pregnancy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-04-25
• Primary completion: 2026-04-24
• Completion: 2026-10-24
• First posted: 2024-03-07
• Last updated: 2024-05-06

Locations

2 sites across 1 country: France