Gynecology-Obstetric center, University of Lorraine, CHRU-Nancy, Nancy, France
Inserm, Diagnostic and Interventional Adaptive Imaging, University of Lorraine, Nancy, France.
BMJ Open. 2020 Dec 10;10(12):e043057. doi: 10.1136/bmjopen-2020-043057.
The absence of companionship during childbirth is known to be responsible for negative emotional birth experience, which can increase the risk of postpartum depression and post-traumatic stress disorder. The context of COVID-19 epidemic and the related confinement could increase the rate of negative experience and mental disorders. The main objective is to compare, in immediate post partum, the maternal sense of control during childbirth between a group of women who gave birth during confinement ('confinement' group) versus a group of women who gave birth after confinement but in the context of epidemic ('epidemic' group) versus a group of control women ('control' group; excluding confinement and epidemic context).
This is a national multicentre prospective cohort study conducted in four French maternity units. We expect to include 927 women in a period of 16 months. Women will be recruited immediately in post partum during three different periods constituting the three groups: 'confinement'; 'epidemic' and 'control' group. The maternal sense of control will be evaluated by the Labour Agentry Scale questionnaire completed immediately in post partum. Postnatal depression (Edinburgh Postnatal Depression Scale), post-traumatic stress disorder (Impact of Event Scale-Revised) and breast feeding (evaluative statement) will be evaluated at 2 months post partum.
The study was approved by the French Ethics Committee, the CPP (Comité de Protection des Personnes) SUD OUEST ET OUTRE-MER IV on 16th of April 2020 with reference number CPP2020-04-040. The results of this study will be published in a peer-reviewed journal and will be presented at relevant conferences.
NCT04348929.
分娩时缺乏陪伴被认为是导致负面情绪分娩体验的原因，这可能会增加产后抑郁和创伤后应激障碍的风险。COVID-19 疫情的背景以及相关的禁闭可能会增加负面体验和精神障碍的发生率。主要目的是比较在产后立即分娩时，禁闭组（在禁闭期间分娩的一组妇女）、疫情组（在疫情背景下分娩但不在禁闭期间的一组妇女）与对照组（控制组；不包括禁闭和疫情背景）的产妇分娩时的控制感。
这是一项在法国四家产科单位进行的全国性多中心前瞻性队列研究。我们预计将在 16 个月的时间内纳入 927 名女性。在三个不同时期将招募产妇，这些时期构成了三个组：禁闭、疫情和对照组。产后立即使用 Labour Agentry 量表问卷评估产妇的控制感。在产后 2 个月评估产后抑郁（爱丁堡产后抑郁量表）、创伤后应激障碍（修订后的事件影响量表）和母乳喂养（评估声明）。
该研究于 2020 年 4 月 16 日获得法国伦理委员会、CPP（保护人员委员会）南西部和海外 IV 的批准，编号为 CPP2020-04-040。本研究的结果将发表在同行评议的期刊上，并将在相关会议上展示。
NCT04348929。
