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临床试验/NCT03316391
NCT03316391已完成不适用

Prospective Study : Association Between Pococyturia and Pre-eclampsia Severity

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Severity of pre-eclampsia

研究概览

简要总结

Pre-eclampsia is an hypertensive disorder appearing during pregnancy, inducing serious maternal, fetal and neonatal mortality and morbidity. Twenty four hours proteinuria is a key element to define pre-eclampsia severity but is delaying the result by 24 hours and constraining for the patient. A simple and rapid indicator for severe preeclampsia would help clinicians to make appropriate decision in patient management. We hypothesized that urinary podocyturia is correlated to preeclampsia severity. This is a prospective, non-interventional, monocentric study.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • women aged 18 years or more
  • single pregnancy
  • admission for pre-eclampsia
  • patient receiving information and non-opposition to participate

排除标准

  • multiple pregnancy
  • in utero fetal demise excepted if associated with pre-eclampsia
  • antecedent of nephropathy
  • fetal malformation, chromosomal anomalies
  • inability to understand information provided
  • prisoner or under administrative supervision

结局指标

主要结局

Severity of pre-eclampsia

时间窗: at childbirth (maximum 10 months)

Severe preeclampsia is defined by preeclampsia with at least one of the following criteria : * severe hypertension (PAS ≥ 160 mmHg et/ou PAD ≥ 110 mmHg) * Renal impairment with: oliguria \<500 ml / 24h or creatinine\> 135 μmol / L or proteinuria\> 5 g/d * acute lung edema or persistent epigastric bar or HELLP syndrome * eclampsia or rebellious neurological disorders (visual disturbances, polykinetic ROT, headache), * thrombocytopenia \<100 G / L * Retro Placental Hematoma (HRP) or fetal repercussion.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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