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临床试验/NCT02879942
NCT02879942已完成不适用

First-trimester Study of the Morphometric Characteristics of the Placenta to Assess the Risk of Preeclampsia and Intrauterine Growth Restriction in Singleton Pregnancies

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 1,390 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,390
试验地点
1
主要终点
Development of preeclampsia

研究概览

简要总结

Preeclampsia (PE) and intrauterine growth restriction (IUGR) are clinical manifestations of placental insufficiency. These complications affect 5-15% of pregnancies, and are responsible for up to 20% of preterm births. Women who develop PE during pregnancy also have an increased risk for cardiovascular events, both at short and long term. This justifies the need to improve diagnostic tools to identify patients at risk for these complications. PE and IUGR are multifactorial entities. Screening algorithms should thus include several parameters to achieve high detection rates. Research has mainly focused in the analysis of biophysical and biochemical parameters, and the study of the placenta itself has not been included in current diagnostic strategies. Investigators hypothesize that detection rates of preeclampsia and intrauterine growth restriction could be improved by the study of placental characteristics in the first trimester of pregnancy.

研究设计

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

入排标准

年龄范围
11 Years 至 60 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnancies with fetuses with CRL between 45 and 80mm
  • absence of chromosomal abnormalities
  • absence of congenital anomalies
  • absence of congenital infections

排除标准

  • patient not accepting to participate in the study
  • multiple pregnancies
  • pregnancies without ultrasonographic confirmation of gestational age

结局指标

主要结局

Development of preeclampsia

时间窗: Up to birth

Pre-eclampsia is diagnosed after 20 week of gestation with systolic blood pressure equal to or greater than 140 mmHg, diastolic blood pressure equal to or greater than 90 mmHg and proteinuria greater than or equal 0.3 g/d by 24 hour urine collection

Development of intrauterine growth restriction

时间窗: At birth

Intrauterine growth restriction is defined as birthweight below 10th centile according to local standards

次要结局

未报告次要终点

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Sponsor

研究点 (1)

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