Prevalence of Psychiatric Disorders During Pregnancy at 2nd Trimester Ultrasound: a Feasibility Study in the General Population (GROUP)
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| ClinicalTrials.gov Identifier: NCT06297252 |
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Recruitment Status :
Not yet recruiting
First Posted : March 7, 2024
Last Update Posted : March 7, 2024
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pregnancy | Diagnostic Test: standardized clinical psychiatric evaluations Diagnostic Test: self-administered psychiatric questionnaire assessments Other: blood sampling | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 140 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Prevalence of Psychiatric Disorders During Pregnancy at 2nd Trimester Ultrasound: a Feasibility Study in the General Population |
| Estimated Study Start Date : | March 2024 |
| Estimated Primary Completion Date : | March 2026 |
| Estimated Study Completion Date : | September 2026 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Pregnant adults
Adults women with an ongoing pregnancy who are scheduled for a T2 ultrasound, regardless of known history or pregnancy context (normal or pathological).
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Diagnostic Test: standardized clinical psychiatric evaluations
The intervention consists of a psychiatric consultation including :
Diagnostic Test: self-administered psychiatric questionnaire assessments
Other: blood sampling A blood sample is taken to form an optional biological collection, comprising 3 samples:
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- 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
- 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) ]
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
- 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 ]Clustering methods (unsupervised classification) will be used to construct homogeneous subgroups of subjects according to comorbidities.
- 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) ]Prevalence of diagnoses unknown to the obstetrical team and/or not documented in the obstetrical record.
- 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) ]Prevalence of diagnoses unknown to the patient.
- 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) ]Prevalence of diagnoses unknown to the general practitioner
- Assess patients' medication compliance using self-administered questionnaires (MARS). [ Time Frame: Baseline (T2 ultrasound) and 2 months post partum ]Medication Adherence Report Scale (MARS) 10 items questionnaire with scores ranging from 0 (lowest adhesion) to 10 (highest)
- Assess patients' treatment beliefs using self-administered questionnaires (BMQ). [ Time Frame: Baseline (T2 ultrasound) and 2 months post partum ]Belief on Medicine Questionnaire (BMQ) with 18 items, with a scores ranging from 18 (lowest belief) to 90 (highest)
- 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 ]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.
- Determine the properties (sensitivity) of screening questionnaires (EPDS) for psychiatric disorders in this population. [ Time Frame: Baseline (T2 ultrasound) and 2 months post partum ]
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)
- Determine the properties (specificity) of screening questionnaires (EPDS) for psychiatric disorders in this population. [ Time Frame: Baseline (T2 ultrasound) and 2 months post partum ]
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)
- 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 ]
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)
- 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 ]
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)
- Determine the properties (sensitivity) of screening questionnaires ( MDQ) for psychiatric disorders in this population. [ Time Frame: Baseline (T2 ultrasound) and 2 months post partum ]
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)
- Determine the properties (specificity) of screening questionnaires ( MDQ) for psychiatric disorders in this population. [ Time Frame: Baseline (T2 ultrasound) and 2 months post partum ]
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)
- 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 ]
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)
- 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 ]
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)
- 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 ]
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)
- 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 ]
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)
- 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 ]
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)
- 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 ]
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)
- Determine the properties (sensitivity) of screening questionnaires (EDEQ) for psychiatric disorders in this population. [ Time Frame: Baseline (T2 ultrasound) and 2 months post partum ]
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.
- Determine the properties (specificity) of screening questionnaires (EDEQ) for psychiatric disorders in this population. [ Time Frame: Baseline (T2 ultrasound) and 2 months post partum ]
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.
- 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 ]
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.
- 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 ]
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.
- 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 ]- Personality Assessment Inventory (PAI) 21 items questionnaire with scores ranging from 21 (the least feeling for their baby) to 84 (Highest)
- 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 ]- Mother-to-Infant Bonding Scale (MIBS) 8 items questionnaire with scores ranging from 0 (highest Bonding) to 24 (Lowest)
- 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 ]Percentage of face-to-face and teleconsultation consultations and the reasons for this choice
- Determine the prevalence of each psychiatric disorder at two months post-inclusion based on a standardized clinical assessment. [ Time Frame: 2 months post partum ]
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Pregnant women only |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06297252
| Contact: Raoul Belzeaux, MD PhD | 04 67 33 79 13 ext +33 | raoul.belzeaux@chu-montpellier.fr | |
| Contact: Florent Fuchs, MD PhD | 04 67 33 23 87 ext +33 | f-fuchs@chu-montpellier.fr |
| Study Director: | Raoul Belzeaux, MD PhD | University Hospital, Montpellier |
| Responsible Party: | University Hospital, Montpellier |
| ClinicalTrials.gov Identifier: | NCT06297252 |
| Other Study ID Numbers: |
RECHMPL23_0189 |
| First Posted: | March 7, 2024 Key Record Dates |
| Last Update Posted: | March 7, 2024 |
| Last Verified: | February 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Mental Disorders During Pregnancy perinatology Social Vulnerability Mental Disorders pregnancy |
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Mental Disorders Problem Behavior Behavioral Symptoms |