Placental Insufficiency Screening During First Trimester by a Combination of Uterine Artery Dopppler, Maternal PlGF and sFLT-1 in Hight Risk Population
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 226
- 试验地点
- 4
- 主要终点
- Occurrence for Pre-eclampsia or SGA
研究概览
简要总结
To assess the role of uterine artery and maternal serum PlGf and sflt-1 and their combination in screening for pre-eclampsia and small -for-gestational age (SGA) fetuses at 12-14 weeks of gestation
详细描述
Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are known as major factors in perinatal morbidity and mortality. Routine antenatal care is focused on the detection of women at increased risk to apply this population a program of careful monitoring and appropriate intervention.
Uterine artery Doppler during anomaly scan at 12 to 14 weeks in selected women at increased risk, has proved to be accurate to detect those who will develop PE or IUGR during the second half of pregnancy.
A variety of angiogenic proteins have been studied as potential markers for pre-eclampsia. Among these protein Plgf and sflt-1 have respectively demonstrated higher and lower levels in pregnant women who will subsequently develop pre-eclampsia.
Our study is aimed to evaluate the performance of serum Plgf and sflt-1 measurement in association with uterine artery Doppler as a screening for placental insufficiency.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Chronic hypertension under medication
- •Insulin or not insulin dependant preexisting diabetes
- •Previous history of pre-eclampsia
- •Previous history of unexplained stillbirth
- •Previous history of placental abruption
- •Previous history of SGA (< 10th centile)
- •History of pre-eclampsia or chronic hypertension before 45 years in the mother or a sister
- •History of vascular pathology before 50 years in the father
- •Obesity (BMI>26)
- •Nulliparous after 38 years
- •Assisted conception with donor
- •Primipaternity after 38 years old or before 20 years old
排除标准
- •Multiple pregnancy
- •Pregnancy requiring termination
- •Unability to understand the study
- •Thrombophilia
- •treatment with heparin
结局指标
主要结局
Occurrence for Pre-eclampsia or SGA
时间窗: During pregnancy and until 72h after delivery
Pre-eclampsia is defined as hypertension (systolic blood pressure 140mmHg or greater or a diastolic blood pressure 90mmHg or greater on at least 2 occasions 4 hour or 1 week apart) accompanied by proteinuria (more or equal to 0.5g/day or 1 dipstick of ++ or more). SGA is defined as birth weight below the 10th centile for gestational age at birth according to the national birthweight distribution of the french population (INSERM)
次要结局
- Early onset pre-eclampsia(During pregnancy and until 72h after delivery)
- Severe pre-eclampsia(During pregnancy and until 72h after delivery)