Prevalence of Psychiatric Disorders During Pregnancy at 2nd Trimester Ultrasound: a Feasibility Study in the General Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: standardized clinical psychiatric evaluations, self-administered psychiatric questionnaire assessments, blood sampling.
- Who it may be relevant to
- Registry conditions: Pregnancy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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
Primary outcome measures
- 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. [Time frame: Baseline (T2 ultrasound)]
Secondary outcome measures (12)
- 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. [Time frame: Baseline (T2 ultrasound)]
- Determine comorbidity profiles across all pathologies, describing whether there are patient groups based on these profiles. [Time frame: Baseline (T2 ultrasound) and 2 months postpartum]
- 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. [Time frame: Baseline (T2 ultrasound)]
- 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. [Time frame: Baseline (T2 ultrasound)]
- 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. [Time frame: Baseline (T2 ultrasound)]
- Assess patients' medication compliance using self-administered questionnaires (MARS). [Time frame: Baseline (T2 ultrasound) and 2 months post partum]
- Assess patients' treatment beliefs using self-administered questionnaires (BMQ). [Time frame: Baseline (T2 ultrasound) and 2 months post partum]
- 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. [Time frame: Baseline (T2 ultrasound) and 2 months post partum]
- Determine the properties (sensitivity) of screening questionnaires (EPDS) for psychiatric disorders in this population. [Time frame: Baseline (T2 ultrasound) and 2 months post partum]
- Determine the properties (specificity) of screening questionnaires (EPDS) for psychiatric disorders in this population. [Time frame: Baseline (T2 ultrasound) and 2 months post partum]
- Determine the properties (positive predictive value) of screening questionnaires (EPDS) for psychiatric disorders in this population. [Time frame: Baseline (T2 ultrasound) and 2 months post partum]
- Determine the properties (negative predictive value) of screening questionnaires (EPDS) for psychiatric disorders in this population. [Time frame: Baseline (T2 ultrasound) and 2 months post partum]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 2 centers
- Centre Hospitalier de Béziers — Béziers
- University Hospital of Montpellier — Montpellier
Publications
- Knabe L, Tanaka C, Tebeka S, Neilson S, Cauvin C, Mercier N, Cayron D, Savelli M, Deruelle P, Fuchs F, Pissarra J, Molinari N, Belzeaux R. Prevalence of psychiatric disorders during pregnancy-a feasibility study at second trimester ultrasound in the general population (GROUP study): study protocol. BMJ Open. 2025 Feb 20;15(2):e091923. doi: 10.1136/bmjopen-2024-091923. PMID 39979054
Identifiers
NCT: NCT06297252 · RECHMPL23_0189