Pregnancy Clinical Trial
— GROUPOfficial title:
Prevalence of Psychiatric Disorders During Pregnancy at 2nd Trimester Ultrasound: a Feasibility Study in the General Population
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.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | October 24, 2026 |
Est. primary completion date | April 24, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier de Béziers | Béziers | |
France | University Hospital of Montpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier | Beziers Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
Baseline (T2 ultrasound) | |
Secondary | 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 |
Baseline (T2 ultrasound) | |
Secondary | 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. | Baseline (T2 ultrasound) and 2 months postpartum | |
Secondary | 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. | Baseline (T2 ultrasound) | |
Secondary | 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. | Baseline (T2 ultrasound) | |
Secondary | 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 | Baseline (T2 ultrasound) | |
Secondary | 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) | Baseline (T2 ultrasound) and 2 months post partum | |
Secondary | 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) | Baseline (T2 ultrasound) and 2 months post partum | |
Secondary | 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. | Baseline (T2 ultrasound) and 2 months post partum | |
Secondary | 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) |
Baseline (T2 ultrasound) and 2 months post partum | |
Secondary | 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) |
Baseline (T2 ultrasound) and 2 months post partum | |
Secondary | 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) |
Baseline (T2 ultrasound) and 2 months post partum | |
Secondary | 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) |
Baseline (T2 ultrasound) and 2 months post partum | |
Secondary | 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) |
Baseline (T2 ultrasound) and 2 months post partum | |
Secondary | 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) |
Baseline (T2 ultrasound) and 2 months post partum | |
Secondary | 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) |
Baseline (T2 ultrasound) and 2 months post partum | |
Secondary | 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) |
Baseline (T2 ultrasound) and 2 months post partum | |
Secondary | 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) |
Baseline (T2 ultrasound) and 2 months post partum | |
Secondary | 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) |
Baseline (T2 ultrasound) and 2 months post partum | |
Secondary | 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) |
Baseline (T2 ultrasound) and 2 months post partum | |
Secondary | 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) |
Baseline (T2 ultrasound) and 2 months post partum | |
Secondary | 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. |
Baseline (T2 ultrasound) and 2 months post partum | |
Secondary | 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. |
Baseline (T2 ultrasound) and 2 months post partum | |
Secondary | 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. |
Baseline (T2 ultrasound) and 2 months post partum | |
Secondary | 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. |
Baseline (T2 ultrasound) and 2 months post partum | |
Secondary | 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) | 2 months post partum | |
Secondary | 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) | 2 months post partum | |
Secondary | 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 | Baseline (T2 ultrasound) and 2 months post partum | |
Secondary | 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 |
2 months post partum |
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