Study for the Evaluation of the Benefits of 1 st Trimester Risk Markers in Detecting Early Onset Pre-eclampsia and the Use of the Placental Growth Factor (PlGF) as a Potential Marker for Trisomy 21 and Other Aneuploidies
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 370
- 试验地点
- 1
- 主要终点
- levels of Placental Protein 13 (PP13) , PIGF, PAPP-A, PIBF
研究概览
简要总结
This is a study for the evaluation of the benefits of 1 st Trimester risk markers in detecting Early Onset Pre-eclampsia and the use of the Placental Growth factor(PIGF) as a potential marker for Trisomy 21 and other aneuploidies.
Aim of this prospective nonprofit study is to analyze the benefits of early onset pre eclampsia risk assessment in the 1st trimester (measuring biochemical markers [PIGF], blood pressure and Doppler ultrasound), and how the results can permit to modify or influence the course of the preeclampsia during the pregnancy. The investigators will also evaluate the potential use of the PIGF as a marker to improve the prenatal screening with the currently used nuchal translucency, serum Pregnancy-associated plasma protein A (PAPP-A) and free beta subunit of human chorionic gonadotropin (fBhCG) parameters.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy
- •Nulliparous pregnancy
- •Gestation age between 6.0-13.6 weeks by last menstrual period verified by ultrasound
- •Blood sample provided at gestational age 6.0-13.6 weeks
- •Informed Consent
排除标准
- •Multi-fetal pregnancy
- •Primiparous or multiparous pregnancy
- •Mental retardation or other mental disorders that impose doubts regarding the true patient's willingness to participate in the study
- •Gestation age below 6.0 or above 13.6 weeks by last menstrual period verified by ultrasound.
- •Lack of blood sample at the specified enrollment period
- •Known major fetal anomaly or fetal demise
- •Lack of demographic data
结局指标
主要结局
levels of Placental Protein 13 (PP13) , PIGF, PAPP-A, PIBF
时间窗: 6-13.6 wks gestation
levels of PP13, PIGF, PAPP-A will de considered in association with Doppler ultrasound and standardised blood pressure measurements to see if they can be used as early risk markers in patients having a delivery before 34 weeks gestation
次要结局
未报告次要终点