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