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孕期精神障碍的患病率——一项针对普通人群孕中期超声检查的可行性研究(GROUP研究):研究方案

Prevalence of psychiatric disorders during pregnancy-a feasibility study at second trimester ultrasound in the general population (GROUP study): study protocol.

作者信息

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

机构信息

Department of Psychiatry and Addictology, University Hospital Center, Montpellier, France

Department of Psychiatry and Addictology, University Hospital Center, Montpellier, France.

出版信息

BMJ Open. 2025 Feb 20;15(2):e091923. doi: 10.1136/bmjopen-2024-091923.

Abstract

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.

摘要

引言

在围产期,女性患精神疾病的风险增加,此类疾病在这一时期极为普遍。此外,这些疾病的诊断存在显著延迟,这会使预后恶化并增加社会负担。描述围产期精神疾病的研究通常聚焦于特定疾病;仅对产后抑郁症以及较少程度上的焦虑症进行了研究。临床医生基于半结构化访谈并依据国际疾病分类诊断标准进行的评估也非常少。

方法与分析

这项多中心前瞻性研究将基于随机选择的孕中期(T2)超声会诊招募140名成年孕妇。主要结局是通过标准化精神评估工具——迷你国际神经精神病学访谈(M.I.N.I.)评估的任何精神疾病的患病率。在T2超声会诊后的10天内,我们将进行M.I.N.I.访谈,收集人口统计学数据,使用哥伦比亚自杀严重程度评定量表评估自杀行为,使用佩克尔问卷描述过去一年中的负面生活事件,并评估社会剥夺情况(医疗中心健康剥夺与不平等评估得分)。参与者还将完成用于筛查特定病症的自填式精神问卷。我们将建立生物样本库。在产后两个月,我们将重复进行问卷调查,并增加母婴联结评估。两次就诊时患者可选择面对面或远程医疗方式。

伦理与传播

所有参与者都将被要求提供书面知情同意书。该研究已获得法国国家委员会(“西部第六区保护人类委员会”)的伦理批准(批准号:23.03919.000236)。研究结果将通过同行评审的期刊出版物以及科学会议进行传播。

试验注册号

NCT06297252。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4a71/11842994/6b8d8769d577/bmjopen-15-2-g001.jpg

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