Prevalence of Psychiatric Disorders During Pregnancy at 2nd Trimester Ultrasound: a Feasibility Study in the General Population

NCT06297252 | Recruiting

• 1 other identifier: RECHMPL23_0189
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

Young women represent a population at risk of psychiatric disorders, the first signs of which often appear between the ages of 15 and 25. Psychiatric disorders are a major source of disability and healthcare costs. The perinatal period is an additional period of psychological vulnerability, during which women are at increased risk of developing or worsening psychiatric disorders. Unfortunately, psychiatric disorders seem to be largely under-diagnosed during this period, and therefore under-treated. The goal of this Prospective multicenter study is to determine the prevalence of the presence of at least one characterized psychiatric disorder, as defined by the use of the Mini International Neuropsychiatric Interview (MINI), in remission or not, during pregnancy, at the time of the second-trimester ultrasound (T2 ultrasound) based on a standardized clinical assessment. Participants will complete self-questionnaires and have a standardized psychiatric evaluation at T2 ultrasound and at 2 months postpartum.

Conditions

Pregnancy

Keywords

Mental Disorders During Pregnancy; perinatology; Social Vulnerability; Mental Disorders; pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 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.

  Baseline (T2 ultrasound)

• Determine comorbidity profiles across all pathologies, describing whether there are patient groups based on these profiles.

  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.

  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.

  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.

  Baseline (T2 ultrasound)

Study Arms (1)

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).

Diagnostic Test: standardized clinical psychiatric evaluations; Diagnostic Test: self-administered psychiatric questionnaire assessments; Other: blood sampling

Interventions

standardized clinical psychiatric evaluations DIAGNOSTIC_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

Pregnant adults

self-administered psychiatric questionnaire assessments DIAGNOSTIC_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)

Pregnant adults

blood sampling OTHER

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

Pregnant adults

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women
• years and over
• Pregnant and consulting for scheduled second trimester ultrasound
• Able to read and write with a good knowledge of French

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Beziers Hospital: collaborator

Study Sites (2)

Centre Hospitalier de Béziers

Béziers, France

NOT YET RECRUITING

University Hospital of Montpellier

Montpellier, 34295, France

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Mental Disorders

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Raoul Belzeaux, MD PhD

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

Raoul Belzeaux, MD PhD

CONTACT

04 67 33 79 13; raoul.belzeaux@chu-montpellier.fr

Florent Fuchs, MD PhD

CONTACT

04 67 33 23 87; f-fuchs@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 7, 2024
• Study Start: April 25, 2024
• Primary Completion: April 24, 2026
• Study Completion (Estimated): October 24, 2026
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)