BMJ open · 2025
Prevalence of psychiatric disorders during pregnancy-a feasibility study at second trimester ultrasound in the general population (GROUP study): study protocol.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Knabe Lucie, Tanaka Camille, Tebeka Sarah, Neilson Samantha, Cauvin Clothilde, Mercier Nicolas, Cayron Daphné, Savelli Morane, Deruelle Philippe, Fuchs Florent, Pissarra Joana, Molinari Nicolas, Belzeaux Raoul
Аннотация
INTRODUCTION: During the perinatal period, women have an increased risk for psychiatric disorders, which are highly prevalent in this context. In addition, there are significant delays in diagnosing these conditions, worsening their prognosis and increasing their societal burden. Studies describing psychiatric disorders in the perinatal period often focus on specific disorders; only postpartum depression and, to a lesser extent, anxiety disorders are studied. There are also very few evaluations conducted by clinicians based on a semistructured interview, relying on the diagnostic criteria of international nosography.
METHODS AND ANALYSIS: This multicentric prospective study will recruit 140 adult pregnant women based on randomly selected second trimester (T2) ultrasound consultations. The primary outcome is the prevalence of any psychiatric disorder assessed with a standardised psychiatric assessment, the Mini-International Neuropsychiatric Interview (M.I.N.I.). Within 10 days after the T2 ultrasound appointment, we will conduct the M.I.N.I., collect demographic data, evaluate suicidal behaviour with the Columbia-Suicide Severity Rating Scale, describe negative life events from the past year using the Paykel questionnaire and evaluation of social deprivation (Evaluation of the Deprivation and Inequalities of Health in Healthcare Centres score). Participants will also complete self-administered psychiatric questionnaires that screen for specific pathologies. We will build a biological sample collection. At two months post partum, we will repeat the questionnaires, adding an assessment of mother-child bonding. Patients can choose between in-person or telemedicine visits on both occasions.
ETHICS AND DISSEMINATION: All participants will be required to provide written informed consent. The study has received ethical approval from the French National Committee ('Comité de Protection des Personnes Ouest VI') (approval number: 23.03919.000236). Results will be disseminated through peer-reviewed journal publications and at scientific conferences and meetings.
TRIAL REGISTRATION NUMBER: NCT06297252.
METHODS AND ANALYSIS: This multicentric prospective study will recruit 140 adult pregnant women based on randomly selected second trimester (T2) ultrasound consultations. The primary outcome is the prevalence of any psychiatric disorder assessed with a standardised psychiatric assessment, the Mini-International Neuropsychiatric Interview (M.I.N.I.). Within 10 days after the T2 ultrasound appointment, we will conduct the M.I.N.I., collect demographic data, evaluate suicidal behaviour with the Columbia-Suicide Severity Rating Scale, describe negative life events from the past year using the Paykel questionnaire and evaluation of social deprivation (Evaluation of the Deprivation and Inequalities of Health in Healthcare Centres score). Participants will also complete self-administered psychiatric questionnaires that screen for specific pathologies. We will build a biological sample collection. At two months post partum, we will repeat the questionnaires, adding an assessment of mother-child bonding. Patients can choose between in-person or telemedicine visits on both occasions.
ETHICS AND DISSEMINATION: All participants will be required to provide written informed consent. The study has received ethical approval from the French National Committee ('Comité de Protection des Personnes Ouest VI') (approval number: 23.03919.000236). Results will be disseminated through peer-reviewed journal publications and at scientific conferences and meetings.
TRIAL REGISTRATION NUMBER: NCT06297252.