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

University Hospital Center (CHU)

Status: Enrolling

Conditions: Pregnancy

Treatments: Other: blood sampling; Diagnostic Test: standardized clinical psychiatric evaluations; Diagnostic Test: self-administered psychiatric questionnaire assessments

Study type: Interventional

Funder types: Other

Identifiers

NCT06297252

RECHMPL23_0189

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

Pregnant adults

Experimental group

Description:

Adults women with an ongoing pregnancy who are scheduled for a T2 ultrasound, regardless of known history or pregnancy context (normal or pathological).

Treatment:

Other: blood sampling

Diagnostic Test: self-administered psychiatric questionnaire assessments

Diagnostic Test: standardized clinical psychiatric evaluations