Clinical trial NCT06297252: Prevalence of Psychiatric Disorders During Pregnancy at 2nd Trimester Ultrasound: a Feasibility Study in the General Population
Official title: Prevalence of Psychiatric Disorders During Pregnancy at 2nd Trimester Ultrasound: a Feasibility Study in the General Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Keywords: Mental Disorders During Pregnancy
perinatology
Social Vulnerability
Mental Disorders
pregnancy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Beziers Hospital
First posted: 2024-03-07
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: To determine the prevalence of the presence of at least one characterized psychiatric disorder, in remission or not, during pregnancy, at the time of the second-trimester ultrasound (T2 ultrasound) based on a standardized clinical assessment.
timeFrame: Baseline (T2 ultrasound)
Secondary outcomes:
measure: To determine the prevalence of each psychiatric disorder characterized during pregnancy at the time of the second-trimester ultrasound, based on a standardized clinical assessment.
timeFrame: Baseline (T2 ultrasound)
measure: Determine comorbidity profiles across all pathologies, describing whether there are patient groups based on these profiles.
timeFrame: Baseline (T2 ultrasound) and 2 months postpartum
measure: Compare the prevalence of psychiatric disorders unknown to the obstetrics team with the prevalence of known psychiatric disorders in pregnant patients at the time of T2 ultrasound.
timeFrame: Baseline (T2 ultrasound)
measure: Compare the prevalence of psychiatric disorders unknown to the patient with the prevalence of known psychiatric disorders in pregnant patients at the time of T2 ultrasound.
timeFrame: Baseline (T2 ultrasound)
measure: Compare the prevalence of psychiatric disorders unknown to the general practitioner with the prevalence of known psychiatric disorders in pregnant patients at the time of T2 ultrasound.
timeFrame: Baseline (T2 ultrasound)
measure: Assess patients' medication compliance using self-administered questionnaires (MARS).
timeFrame: Baseline (T2 ultrasound) and 2 months post partum
measure: Assess patients' treatment beliefs using self-administered questionnaires (BMQ).
timeFrame: Baseline (T2 ultrasound) and 2 months post partum
measure: Determine the sociodemographic, psychological, psychiatric, medical and obstetric factors, as well as those associated with access to care and the care pathway associated with known or unknown diagnoses during pregnancy.
timeFrame: Baseline (T2 ultrasound) and 2 months post partum
measure: Determine the properties (sensitivity) of screening questionnaires (EPDS) for psychiatric disorders in this population.
timeFrame: Baseline (T2 ultrasound) and 2 months post partum
measure: Determine the properties (specificity) of screening questionnaires (EPDS) for psychiatric disorders in this population.
timeFrame: Baseline (T2 ultrasound) and 2 months post partum
measure: Determine the properties (positive predictive value) of screening questionnaires (EPDS) for psychiatric disorders in this population.
timeFrame: Baseline (T2 ultrasound) and 2 months post partum
measure: Determine the properties (negative predictive value) of screening questionnaires (EPDS) for psychiatric disorders in this population.
timeFrame: Baseline (T2 ultrasound) and 2 months post partum
measure: Determine the properties (sensitivity) of screening questionnaires ( MDQ) for psychiatric disorders in this population.
timeFrame: Baseline (T2 ultrasound) and 2 months post partum
measure: Determine the properties (specificity) of screening questionnaires ( MDQ) for psychiatric disorders in this population.
timeFrame: Baseline (T2 ultrasound) and 2 months post partum
measure: Determine the properties (positive predictive value) of screening questionnaires ( MDQ) for psychiatric disorders in this population.
timeFrame: Baseline (T2 ultrasound) and 2 months post partum
measure: Determine the properties (negative predictive value) of screening questionnaires ( MDQ) for psychiatric disorders in this population.
timeFrame: Baseline (T2 ultrasound) and 2 months post partum
measure: Determine the properties (sensitivity) of screening questionnaires (PCL-5) for psychiatric disorders in this population.
timeFrame: Baseline (T2 ultrasound) and 2 months post partum
measure: Determine the properties (specificity) of screening questionnaires (PCL-5) for psychiatric disorders in this population.
timeFrame: Baseline (T2 ultrasound) and 2 months post partum
measure: Determine the properties (positive predictive value) of screening questionnaires (PCL-5) for psychiatric disorders in this population.
timeFrame: Baseline (T2 ultrasound) and 2 months post partum
measure: Determine the properties (negative predictive value) of screening questionnaires (PCL-5) for psychiatric disorders in this population.
timeFrame: Baseline (T2 ultrasound) and 2 months post partum
measure: Determine the properties (sensitivity) of screening questionnaires (EDEQ) for psychiatric disorders in this population.
timeFrame: Baseline (T2 ultrasound) and 2 months post partum
measure: Determine the properties (specificity) of screening questionnaires (EDEQ) for psychiatric disorders in this population.
timeFrame: Baseline (T2 ultrasound) and 2 months post partum
measure: Determine the properties (positive predictive value) of screening questionnaires (EDEQ) for psychiatric disorders in this population.
timeFrame: Baseline (T2 ultrasound) and 2 months post partum
measure: Determine the properties (negative predictive value) of screening questionnaires (EDEQ) for psychiatric disorders in this population.
timeFrame: Baseline (T2 ultrasound) and 2 months post partum
measure: Compare mother-child bonding difficulties between patients with and without a psychiatric diagnosis at the time of the study, using scales (PAI).
timeFrame: 2 months post partum
measure: Compare mother-child bonding difficulties between patients with and without a psychiatric diagnosis at the time of the study, using scales (MIBS).
timeFrame: 2 months post partum
measure: Describe how the study will be carried out, either in person or by teleconsultation, and the reasons for this choice.
timeFrame: Baseline (T2 ultrasound) and 2 months post partum
measure: Determine the prevalence of each psychiatric disorder at two months post-inclusion based on a standardized clinical assessment.
timeFrame: 2 months post partum
Other outcomes:
Locations:
city: Béziers
country: France
facility: Centre Hospitalier de Béziers
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Raoul Belzeaux, MD PhD
role: STUDY_DIRECTOR
References: