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临床试验/NCT03354832
NCT03354832终止不适用

Research Action on Infant Mortality in Reunion Island Evaluation of Factors Affecting In-utero Foetal Death and New-born Death in Reunion Island

Centre Hospitalier Universitaire de la Réunion1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2017年3月14日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
45
试验地点
1
主要终点
Rate of suboptimal care

研究概览

简要总结

Infant mortality is still relevant despite the improvement and the accessibility of hospital care. Premature birth are two fold higher than in metropolitan France. Some factors has been suspected such as precariousness, alcoholism, congenital malformation, care accessibility, epidemic environment ... Nevertheless, the impact of these factors on foetal death or new-born death are not yet sufficiently quantified to provide appropriate care and prevention action in Reunion Island.

详细描述

Through the analysis of interview of the mothers that have lost their infant during pregnancy or just after birth, the study aims to draw a picture of the pregnancy cares offer and pregnancy conditions in Reunion Island.

This study is an non interventional case-control study. Socio-economic conditions, pregnancy care and prevention are screened to identified the major cause of foetal or new-born death in Reunion Island. These data are still lacking and will be useful to identify which public health actions that should be organized.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Case: foetal death (foetus weighing more than 500 g or more than 22-amenorrhea weeks old) or new-born death (premature: more than 23-amenorrhea weeks old or mature)
  • Control: premature (more than 23-amenorrhea weeks old) or mature new-born, alive when the leave the hospital

排除标准

  • medical abortion
  • second pregnancy during the study period
  • case under forensic expertise

结局指标

主要结局

Rate of suboptimal care

时间窗: within 4 weeks after birth (control) or lost (case)

The main suboptimal care are searched: * lack or inefficient corticotherapy during pregnancy * infant birth in an under equipped hospital, without facilities for premature birth * prenatal diagnosis of serious congenital malformations involving specific care at birth * lack of B-streptococcus detection * unexpected caesarean section during delivery * unexpected dystocia

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

研究点 (1)

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