PregnancyGROUPNCT06297252
Prevalence of Psychiatric Disorders During Pregnancy at 2nd Trimester Ultrasound: a Feasibility Study in the General Population
A study testing standardized clinical psychiatric evaluations, self-administered psychiatric questionnaire assessments and blood sampling in people with Pregnancy, run by University Hospital, Montpellier at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- standardized clinical psychiatric evaluations, self-administered psychiatric questionnaire assessments and blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Apr 2024to 24 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women
- 18 years and over
- Pregnant and consulting for scheduled second trimester ultrasound
- Able to read and write with a good knowledge of French
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Not yet recruiting
Centre Hospitalier de Béziers
Béziers
Radoine HAOUI, MD, radoine.haoui@ch-beziers.fr
- Recruiting
University Hospital of Montpellier
Montpellier, 34295
Raoul BELZEAUX, MD PhD, raoul.belzeaux@chu-montpellier.fr
Raoul BELZEAUX, MD-PhD
About this study
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.
Read more
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.
Read the 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
- Being tested
- standardized clinical psychiatric evaluations, self-administered psychiatric questionnaire assessments, blood sampling
- Keywords
- Mental Disorders During Pregnancy, perinatology, Social Vulnerability, Mental Disorders, pregnancy
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized clinical psychiatric evaluationsDiagnostic test
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
self-administered psychiatric questionnaire assessmentsDiagnostic test
- 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)
blood samplingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Pregnant adults | Experimental | Adults women with an ongoing pregnancy who are scheduled for a T2 ultrasound, regardless of known history or pregnancy context (normal or pathological). Receives: Diagnostic Test: standardized clinical psychiatric evaluations; Diagnostic Test: self-administered psychiatric questionnaire assessments; Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Presence of at least one psychiatric disorder (evaluated by the MINI), of any kind, in remission or not, during pregnancy, at the time of the T2 ultrasound.
The MINI score verifies the presence or absence of criteria for the most common psychiatric illnesses and assess the 17 most common psychiatric disorders and suicidality in DSM-III-R, DSM-IV and DSM-5 and ICD-10.
- Affective Disorders, Psychotic
- Agoraphobia
- Alcoholism
- Anorexia Nervosa
- Antisocial Personality Disorder
- Anxiety Disorders
- Bipolar and Related Disorders
- Bipolar Disorder
- Bulimia Nervosa
- Depressive Disorder, Major
- Mania
- Obsessive-Compulsive Disorder
- Panic Disorder
- Phobia, Social
- Psychotic Disorders
- Self-Injurious Behavior
- Stress Disorders, Post-Traumatic
- Substance-Related Disorders
- Suicidal Ideation
Measured: Baseline (T2 ultrasound)
Secondary outcomes (28)
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.
Standardized clinical assessment includes MINI, Columbia-Suicide Severity Rating Scale (CSSR-S) questionnaire used for suicide assessment (scale from 0 to 5 (highest suicidal risk)), Negative life events in the last 12 months will be assessed using the Paykel questionnaire, and a medical examination by a psychiatrist.
All these elements are used together to diagnose psychiatric disorders and determine their individual prevalence.
The MINI score verifies the presence or absence of criteria which assess the 17 most common psychiatric disorders and suicidality : Affective Disorders, Psychotic, Agoraphobia, Alcoholism, Anorexia Nervosa, Antisocial Personality Disorder, Anxiety Disorders, Bipolar and Related Disorders, Bipolar Disorder, Bulimia Nervosa, Depressive Disorder, Major, Mania, Obsessive-Compulsive Disorder, Panic Disorder, Phobia Social, Psychotic Disorders, Self-Injurious Behavior, Stress Disorders, Post-Traumatic, Substance-Related Disorders, Suicidal Ideation
Measured: Baseline (T2 ultrasound)
Determine comorbidity profiles across all pathologies, describing whether there are patient groups based on these profiles.
Clustering methods (unsupervised classification) will be used to construct homogeneous subgroups of subjects according to comorbidities.
Measured: 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.
Prevalence of diagnoses unknown to the obstetrical team and/or not documented in the obstetrical record.
Measured: 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.
Prevalence of diagnoses unknown to the patient.
Measured: 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.
Prevalence of diagnoses unknown to the general practitioner
Measured: Baseline (T2 ultrasound)
Assess patients' medication compliance using self-administered questionnaires (MARS).
Medication Adherence Report Scale (MARS) 10 items questionnaire with scores ranging from 0 (lowest adhesion) to 10 (highest)
Measured: Baseline (T2 ultrasound) and 2 months post partum
Assess patients' treatment beliefs using self-administered questionnaires (BMQ).
Belief on Medicine Questionnaire (BMQ) with 18 items, with a scores ranging from 18 (lowest belief) to 90 (highest)
Measured: 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.
Evaluation of socio-demographic dimension with the French score : Evaluation of precariousness and health inequalities in health examination centers (Evaluation de la Précarité et des Inégalités de santé dans les Centres d'Examens de Santé EPICES). This score assesses the marital status, place of residence, level of education, current employment situation, social security coverage, factors of precariousness.
Measured: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (sensitivity) of screening questionnaires (EPDS) for psychiatric disorders in this population.
the results of these tests according to the thresholds already established in the literature will be compared with the results of the corresponding MINI sub-domains, and the sensitivity value will be calculated along with the associated 95% confidence intervals.
- Accuracy of the Edinburgh Postnatal Depression Scale (EPDS) is a 10 items questionnaire with scores ranging from 0 (lowest depression score) to 30 (Highest)
Measured: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (specificity) of screening questionnaires (EPDS) for psychiatric disorders in this population.
the results of these tests according to the thresholds already established in the literature will be compared with the results of the corresponding MINI sub-domains, and the specificity value will be calculated along with their associated 95% confidence intervals.
- Accuracy of the Edinburgh Postnatal Depression Scale (EPDS) is a 10 items questionnaire with scores ranging from 0 (lowest depression score) to 30 (Highest)
Measured: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (positive predictive value) of screening questionnaires (EPDS) for psychiatric disorders in this population.
the results of these tests according to the thresholds already established in the literature will be compared with the results of the corresponding MINI sub-domains, and the positive predictive value will be calculated along with their associated 95% confidence intervals.
- Accuracy of the Edinburgh Postnatal Depression Scale (EPDS) is a 10 items questionnaire with scores ranging from 0 (lowest depression score) to 30 (Highest)
Measured: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (negative predictive value) of screening questionnaires (EPDS) for psychiatric disorders in this population.
the results of these tests according to the thresholds already established in the literature will be compared with the results of the corresponding MINI sub-domains negative predictive value will be calculated along with their associated 95% confidence intervals.
- Accuracy of the Edinburgh Postnatal Depression Scale (EPDS) is a 10 items questionnaire with scores ranging from 0 (lowest depression score) to 30 (Highest)
Measured: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (sensitivity) of screening questionnaires ( MDQ) for psychiatric disorders in this population.
the results of these tests according to the thresholds already established in the literature will be compared with the results of the corresponding MINI sub-domains, and the sensitivity will be calculated along with their associated 95% confidence intervals.
- Mood Disorder Questionnaire (MDQ) composed of 15-items with scores ranging from 0 (lowest risk of mood disorder) to 13 (Highest)
Measured: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (specificity) of screening questionnaires ( MDQ) for psychiatric disorders in this population.
the results of these tests according to the thresholds already established in the literature will be compared with the results of the corresponding MINI sub-domains, and the specificity will be calculated along with their associated 95% confidence intervals.
- Mood Disorder Questionnaire (MDQ) composed of 15-items with scores ranging from 0 (lowest risk of mood disorder) to 13 (Highest)
Measured: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (positive predictive value) of screening questionnaires ( MDQ) for psychiatric disorders in this population.
the results of these tests according to the thresholds already established in the literature will be compared with the results of the corresponding MINI sub-domains, and the positive predictive value will be calculated along with their associated 95% confidence intervals.
- Mood Disorder Questionnaire (MDQ) composed of 15-items with scores ranging from 0 (lowest risk of mood disorder) to 13 (Highest)
Measured: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (negative predictive value) of screening questionnaires ( MDQ) for psychiatric disorders in this population.
the results of these tests according to the thresholds already established in the literature will be compared with the results of the corresponding MINI sub-domains, and the negative predictive value will be calculated along with their associated 95% confidence intervals.
- Mood Disorder Questionnaire (MDQ) composed of 15-items with scores ranging from 0 (lowest risk of mood disorder) to 13 (Highest)
Measured: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (sensitivity) of screening questionnaires (PCL-5) for psychiatric disorders in this population.
the results of these tests according to the thresholds already established in the literature will be compared with the results of the corresponding MINI sub-domains, and the sensitivity will be calculated along with their associated 95% confidence intervals.
- Post-traumatic Stress Disorder Checklist for DSM-V (PCL-5) is a 20 items questionnaires with scores ranging from 0 (lowest risk of PTSD) to 80 (Highest)
Measured: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (specificity) of screening questionnaires (PCL-5) for psychiatric disorders in this population.
the results of these tests according to the thresholds already established in the literature will be compared with the results of the corresponding MINI sub-domains, and the specificity will be calculated along with their associated 95% confidence intervals.
- Post-traumatic Stress Disorder Checklist for DSM-V (PCL-5) is a 20 items questionnaires with scores ranging from 0 (lowest risk of PTSD) to 80 (Highest)
Measured: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (positive predictive value) of screening questionnaires (PCL-5) for psychiatric disorders in this population.
the results of these tests according to the thresholds already established in the literature will be compared with the results of the corresponding MINI sub-domains, and the positive predictive value will be calculated along with their associated 95% confidence intervals.
- Post-traumatic Stress Disorder Checklist for DSM-V (PCL-5) is a 20 items questionnaires with scores ranging from 0 (lowest risk of PTSD) to 80 (Highest)
Measured: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (negative predictive value) of screening questionnaires (PCL-5) for psychiatric disorders in this population.
the results of these tests according to the thresholds already established in the literature will be compared with the results of the corresponding MINI sub-domains, and the negative predictive value will be calculated along with their associated 95% confidence intervals.
- Post-traumatic Stress Disorder Checklist for DSM-V (PCL-5) is a 20 items questionnaires with scores ranging from 0 (lowest risk of PTSD) to 80 (Highest)
Measured: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (sensitivity) of screening questionnaires (EDEQ) for psychiatric disorders in this population.
the results of these tests according to the thresholds already established in the literature will be compared with the results of the corresponding MINI sub-domains, and the sensitivity will be calculated along with their associated 95% confidence intervals.
- Eating Disorder Examination Questionnaire (EDE-Q) is a 28 items questionnaires with a higher score indicating more problematic eating difficulties.
Measured: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (specificity) of screening questionnaires (EDEQ) for psychiatric disorders in this population.
the results of these tests according to the thresholds already established in the literature will be compared with the results of the corresponding MINI sub-domains, specificity will be calculated along with their associated 95% confidence intervals.
- Eating Disorder Examination Questionnaire (EDE-Q) is a 28 items questionnaires with a higher score indicating more problematic eating difficulties.
Measured: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (positive predictive value) of screening questionnaires (EDEQ) for psychiatric disorders in this population.
the results of these tests according to the thresholds already established in the literature will be compared with the results of the corresponding MINI sub-domains, and the positive predictive value will be calculated along with their associated 95% confidence intervals.
- Eating Disorder Examination Questionnaire (EDE-Q) is a 28 items questionnaires with a higher score indicating more problematic eating difficulties.
Measured: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (negative predictive value) of screening questionnaires (EDEQ) for psychiatric disorders in this population.
the results of these tests according to the thresholds already established in the literature will be compared with the results of the corresponding MINI sub-domains, and the negative predictive value will be calculated along with their associated 95% confidence intervals.
- Eating Disorder Examination Questionnaire (EDE-Q) is a 28 items questionnaires with a higher score indicating more problematic eating difficulties.
Measured: Baseline (T2 ultrasound) and 2 months post partum
Compare mother-child bonding difficulties between patients with and without a psychiatric diagnosis at the time of the study, using scales (PAI).
- Personality Assessment Inventory (PAI) 21 items questionnaire with scores ranging from 21 (the least feeling for their baby) to 84 (Highest)
Measured: 2 months post partum
Compare mother-child bonding difficulties between patients with and without a psychiatric diagnosis at the time of the study, using scales (MIBS).
- Mother-to-Infant Bonding Scale (MIBS) 8 items questionnaire with scores ranging from 0 (highest Bonding) to 24 (Lowest)
Measured: 2 months post partum
Describe how the study will be carried out, either in person or by teleconsultation, and the reasons for this choice.
Percentage of face-to-face and teleconsultation consultations and the reasons for this choice
Measured: Baseline (T2 ultrasound) and 2 months post partum
Determine the prevalence of each psychiatric disorder at two months post-inclusion based on a standardized clinical assessment.
Standardized clinical assessment includes MINI, Columbia-Suicide Severity Rating Scale (CSSR-S) questionnaire used for suicide assessment (scale from 0 to 5 (highest suicidal risk)), Negative life events in the last 12 months will be assessed using the Paykel questionnaire, and a medical examination by a psychiatrist.
All these elements are used together to diagnose psychiatric disorders and determine their individual prevalence.
The MINI score verifies the presence or absence of criteria which assess the 17 most common psychiatric disorders and suicidality : Affective Disorders, Psychotic, Agoraphobia, Alcoholism, Anorexia Nervosa, Antisocial Personality Disorder, Anxiety Disorders, Bipolar and Related Disorders, Bipolar Disorder, Bulimia Nervosa, Depressive Disorder, Major, Mania, Obsessive-Compulsive Disorder, Panic Disorder, Phobia Social, Psychotic Disorders, Self-Injurious Behavior, Stress Disorders, Post-Traumatic, Substance-Related Disorders, Suicidal Ideation
Measured: 2 months post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start25 Apr 2024
- Primary completion24 Apr 2026 (estimated)
- Study completion24 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Beziers Hospital
- Responsible party
- Sponsor
- Investigators
- Raoul Belzeaux, MD PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297252
- Sponsor's protocol ID
- RECHMPL23_0189
- Acronym
- GROUP
- Status last verified
- May 2024
- First submitted
- 19 Feb 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39979054
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Psychiatric Disorders During Pregnancy at 2nd Trimester Ultrasound: a Feasibility Study in the General Population
- ClinicalTrials.gov ID
- NCT06297252
- Acronym / sponsor ID
- GROUP / RECHMPL23_0189
- Conditions
- Pregnancy
- Keywords
- Mental Disorders During Pregnancy, perinatology, Social Vulnerability, Mental Disorders, pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Beziers Hospital
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 24 Apr 2026 (estimated)
- Study completion
- 24 Oct 2026 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant adults | Experimental | Diagnostic Test: standardized clinical psychiatric evaluations, Diagnostic Test: self-administered psychiatric questionnaire assessments, Other: blood samplingAdults women with an ongoing pregnancy who are scheduled for a T2 ultrasound, regardless of known history or pregnancy context (normal or pathological). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women
- 18 years and over
- Pregnant and consulting for scheduled second trimester ultrasound
- Able to read and write with a good knowledge of French
Key exclusion criteria (8 listed)
- Unable to understand French
- Illiterate
- Underage patient at time of second trimester ultrasound
- Patient under guardianship or curatorship
- Patient deprived of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standardized clinical psychiatric evaluationsThe 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 | Pregnant adults |
| 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) | Diagnostic test | Pregnant adults |
| blood samplingA 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 | Other | Pregnant adults |
Primary outcome
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)
Presence of at least one psychiatric disorder (evaluated by the MINI), of any kind, in remission or not, during pregnancy, at the time of the T2 ultrasound. The MINI score verifies the presence or absence of criteria for the most common psychiatric illnesses and assess the 17 most common psychiatric disorders and suicidality in DSM-III-R, DSM-IV and DSM-5 and ICD-10. * Affective Disorders, Psychotic * Agoraphobia * Alcoholism * Anorexia Nervosa * Antisocial Personality Disorder * Anxiety Disorders * Bipolar and Related Disorders * Bipolar Disorder * Bulimia Nervosa * Depressive Disorder, Major * Mania * Obsessive-Compulsive Disorder * Panic Disorder * Phobia, Social * Psychotic Disorders * Self-Injurious Behavior * Stress Disorders, Post-Traumatic * Substance-Related Disorders * Suicidal Ideation
28 secondary outcomes
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
Determine the properties (sensitivity) of screening questionnaires ( MDQ) for psychiatric disorders in this population.
Time frame: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (specificity) of screening questionnaires ( MDQ) 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 ( MDQ) 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 ( MDQ) for psychiatric disorders in this population.
Time frame: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (sensitivity) of screening questionnaires (PCL-5) for psychiatric disorders in this population.
Time frame: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (specificity) of screening questionnaires (PCL-5) 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 (PCL-5) 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 (PCL-5) for psychiatric disorders in this population.
Time frame: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (sensitivity) of screening questionnaires (EDEQ) for psychiatric disorders in this population.
Time frame: Baseline (T2 ultrasound) and 2 months post partum
Determine the properties (specificity) of screening questionnaires (EDEQ) 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 (EDEQ) 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 (EDEQ) for psychiatric disorders in this population.
Time frame: Baseline (T2 ultrasound) and 2 months post partum
Compare mother-child bonding difficulties between patients with and without a psychiatric diagnosis at the time of the study, using scales (PAI).
Time frame: 2 months post partum
Compare mother-child bonding difficulties between patients with and without a psychiatric diagnosis at the time of the study, using scales (MIBS).
Time frame: 2 months post partum
Describe how the study will be carried out, either in person or by teleconsultation, and the reasons for this choice.
Time frame: Baseline (T2 ultrasound) and 2 months post partum
Determine the prevalence of each psychiatric disorder at two months post-inclusion based on a standardized clinical assessment.
Time frame: 2 months post partum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Derived from this study: PubMed 39979054Knabe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raoul Belzeaux, MD PhD study director
University Hospital, Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standardized clinical psychiatric evaluations, self-administered psychiatric questionnaire assessments and blood sampling in people with Pregnancy, run by University Hospital, Montpellier at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raoul Belzeaux, MD PhD (04 67 33 79 13 ext. +33, raoul.belzeaux@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Baseline (T2 ultrasound)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06297252, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.