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临床试验/NCT04605172
NCT04605172已完成不适用

The Impact of the SARS CoV-2 Lockdown Policy on Spontaneous Premature Birth at the Regional University Maternity Hospital of Nancy

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 812 人开始时间: 2020年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
812
试验地点
1
主要终点
Evaluate the impact of confinement on the rate of spontaneous prematurity at the Regional University Maternity Hospital of Nancy (MRUN)

研究概览

简要总结

Preterm labor (PL) is the leading cause of hospitalization during pregnancy and premature birth the leading cause of fetal morbidity and mortality in France. PL is defined by regular and painful uterine contractions associated with a change in the cervix, between 22 and 36 weeks of gestation.

It has been shown that the risk of spontaneous prematurity increases particularly in case of working over 40 hours per week, hard physically conditions, or prolonged daily transport time. Rest is one of the most efficient measure to prevent PL and should be proposed to all pregnant women, and combined with other therapies such as tocolysis or cerclage when needed.

The very particular period of lockdown during the COVID-19 pandemic had pregnant women to drastically reduce their activity. They suspended their work and stayed home for various reasons such as pregnancy in progress, children at home, and also collective reasons such as teleworking or workplace closure.

During the lockdown period from March 17th to May 11th 2020, fewer preterm labor and less spontaneous prematurity have been suspected by the neonatology and obstetrics teams throughout the Lorraine region.

Our study aims to objectively confirm this observation. In this investigation we aim to find a relationship between lockdown, PL and spontaneous prematurity which would need to re-evaluate public health recommendations for pregnant women outside the lockdown.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
0 Days 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Any prematurely born infant before 37 SA and care for by the level III NICU, over the predefined periods.

排除标准

  • non premature newborn

结局指标

主要结局

Evaluate the impact of confinement on the rate of spontaneous prematurity at the Regional University Maternity Hospital of Nancy (MRUN)

时间窗: baseline

Number of prematurely born infants

次要结局

  • Evaluate the impact of confinement on the type of prematurity rate: spontaneous or not(baseline)
  • Evaluate the impact of confinement on the outborn rate managed by the Regional Neonatal transport team for prematurity(baseline)
  • Evaluate the type of prematurity over the period of confinement(baseline)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean-Michel HASCOET

Professor

Central Hospital, Nancy, France

研究点 (1)

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