Birth Experience During COVID-19 Confinement (Confinement and Fostering Intrapartum Care)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 927
- 试验地点
- 2
- 主要终点
- "Labor Agentry Scale questionnaire" score in immediate post-partum (duration of hospital stay)
研究概览
简要总结
Different studies have demonstrated that the absence of companionship during labor and childbirth may be responsible for a negative birth experience, an increased risk of postnatal depression and/or post traumatic stress disorders. These situation may also have a negative impact on mother-child interaction, on marital and family relationship and on the rate of maternal suicide in postpartum. However, these previous results cannot be extrapolated in the current context where the absence of the companionship is imposed by the confinement framework. The objective of the CONFINE study is to assess, for the first time, the birth experience of women in the context of limited social support in the immediate post-partum period due to confinement, as well as the associated over-risk of mental disorders, compared to a post-partum without social restriction.
详细描述
The primary 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 context of epidemic).
The secondary objectives are:
- To compare, at two months post-partum, the maternal sense of control during childbirth between the three groups.
- To compare, at two months of post-partum, scoring of self-questionnaire Edinburg Postnatale Depression Scale (EPDS) for the post-natal depression between the three groups.
- To compare at two months of post-partum, scoring of self-questionnaire Impact of Event Scale - Revised (IES-R) for posttraumatic stress disorder, between the three groups.
- To compare, at two months of post-partum, the breastfeeding between the three groups.
- To compare, at two months of post-partum, the quality of life (SF-12) between the three groups.
- To compare the evolution of quality of life at two months of post-partum between the three groups.
- To compare the rate of post-natal depression between the three groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •Woman who is >= 18 years old
- •Woman having just given birth from 37 weeks of gestation (singleton pregnancy)
- •Woman affiliated to a social security
- •Woman with a level of understanding of written French sufficient to answer the questionnaires.
- •Woman having received complete information on the organization of the research and having given her informed consent in written form.
- •Specific inclusion criteria according to the group For "confinement"group : Delivery during covid-19 confinement period
- •For "epidemic" group: Delivery after confinement period and before the withdrawal of sanitary measures implemented (mask, social distancing, limited visits during post-partum immediate)
- •For "control" group: Start of pregnancy after confinement and delivery after the withdrawal of all sanitary measures (mask, social distancing, limited visits during post-partum immediate)
排除标准
- •Major mentioned in articles L.1121-6 and L-1121-8 of Health Public Code.
- •Woman with psychiatric disorders such as depressive syndrome
- •Woman considered positive for covid-19 and treated as such at the time of delivery (regardless of test result)
- •Newborn with congenital abnormalities
- •Stillbirth
结局指标
主要结局
"Labor Agentry Scale questionnaire" score in immediate post-partum (duration of hospital stay)
时间窗: through study completion, an average of 16 months
次要结局
- Diagnosis of post-natal depression (made by a specialist)(through study completion, an average of 16 months)
- Edinburg Postnatale Depression Scale questionnaire" score at two months after birth(through study completion, an average of 16 months)
- "Labor Agentry Scale questionnaire" score at two months after birth(through study completion, an average of 16 months)
- "Impact of Event Scale - Revised questionnaire" score at two months after birth(through study completion, an average of 16 months)
- "SF-12 Quality of life questionnaire" score at two months after birth(through study completion, an average of 16 months)
- Breastfeeding statement at two months after birth(through study completion, an average of 16 months)
- "SF-12 Quality of life questionnaire" score in immediate post-partum(through study completion, an average of 16 months)
研究者
BERTHOLDT Charline
Principal Investigator (obstetrician-gynecologist)
Central Hospital, Nancy, France