Psychological Impact of the Lockdown on Patients Giving Birth During the COVID-19 Epidemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 287
- 试验地点
- 2
- 主要终点
- Proportion of patients with postpartum depression defined by an EPDS score >12
研究概览
简要总结
The COVID-19 epidemic has a major impact on the organization of hospital structures as a whole. Regarding the functioning of the Maternities, it was decided by the three Maternities of AP-HP. Sorbonne University of the Pitié-Salpêtrière, Trousseau and Tenon sites, from March 20, 2020 to no longer authorize visits during the stay of mothers following childbirth. This prohibition has also been extended to spouses. This measure was guided by a concern to protect both the patients, their newborn and the entire staff of the aftermath.
The period surrounding a birth is a period of strong emotional impact with an incidence of postpartum depression estimated at 15% in the general population (1). The separation of women from their spouses during this period could expose them to greater psychological vulnerability. In addition, when they return home, the patients will be isolated from their relatives due to the quarantine, which is an additional risk factor for postpartum depression. The teams of the three maternity units of AP-HP. Sorbonne University have organized themselves to be able to respond to situations of mental vulnerability during their stay with the intervention of maternity psychologists and psychiatrists and child psychiatrists as is done in the treatment usual charge. In addition, anticipating situations of greater vulnerability linked to the health crisis, the Maternity teams decided to set up a follow-up of patients after their return home through a telephone interview with psychologists or student psychologists in Master at D10 - D12 and 6-8 weeks postpartum in order to identify patients at increased risk of postpartum depression and to set up appropriate management if necessary for these patients.
We therefore propose through this project to describe the consequences of this separation from the spouse during the postpartum stay and then with the family after returning home within the context of quarantine by assessing the incidence of post-partum depression during this sanitary crisis. A telephone interview of all the patients will be proposed on D10 - D12 and at 6-8 weeks postpartum using specific questionnaire to calculate a score of depression. This early identification will allow the establishment of an adapted psychological follow-up.
详细描述
The main objective of this study is to assess the emotional impact of the separation of women from their spouses following childbirth and their family isolation when returning home within the context of quarantine due to the COVID epidemic.
The secondary objectives are:
- To identify the factors of greatest vulnerability or resilience of the patients in the immediate postpartum period (6-8 weeks after delivery).
- To evaluate the impact of quarantine on the couples (DAS-16 scale), the experience of childbirth (PPQ scale), mother-child interactions (MIBS) at D10-D12 postpartum and at 6-8 weeks postpartum.
- Recording of all interviews allowing a qualitative study of the verbatim by the use of N-Vivo software allowing the analysis of unstructured and qualitative data.
The primary endpoint will be the proportion of patients with postpartum depression defined by EPDS score >12 at D10-12 and 6-8 weeks postpartum. The EPDS relies on 10 specific items which allows the calculation of a depression score. A threshold > 12 is used in research to define the existence of depressive symptoms. For research, the score can be used as a continuous variable or in class with the threshold value 12.
The secondary end points will be:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •- Single pregnancy
- •Birth of a child living without hospitalisation of the child in Neonatology (outside the accommodation of the newborn in Neonatology for maternal reasons)
- •Patient speaks and understands French
- •Patient affiliated to social security
- •Major patient
- •Written consent or nonopposition if retrospectif inclusion
排除标准
- •Protected patient or patient unable to give consent
结局指标
主要结局
Proportion of patients with postpartum depression defined by an EPDS score >12
时间窗: Between day 10 and day 12
assess the emotional impact of women's separation from their partners following childbirth and then their family isolation when they return home in the context of the health crisis linked to the COVID-19 epidemic
次要结局
- Occurrence of a maternal or fetal pathology in a previous pregnancy(Between day 1 and day 5)
- Perinatal post traumatic stress disorder questionnaire (PPQ scale)(Between day 10 and day 12)
- Measure Qualitative Interviews by Grounded theory(Week 14)
- Mother to infant bonding scale (MIBS) autoquestionnaire(Between day 10 and day 12 and at between week 6 and week 8)
- Dyadic adjustment scale 16 (DAS-16)(Between day 10 and day 12 and at between week 6 and week 8)
- Presence of psycological maternal risk factor(Between day 1 and day 5)
- Socio-demographic data(Between day 1 and day 5)
- Pregnant maternal pathology (hypertension, diabetes, threat of premature delivery)(Between day 1 and day 5)