Prediction of Placental Fetal Growth Restriction in High Risk Population (PoPFGR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Present of maternal-vascular-malperfusion (MVM)-FGR
研究概览
简要总结
This study intends to prospectively enroll high-risk pregnant women to establish a multicenter cohort. By combining maternal basic characteristics, medical history, early pregnancy ultrasound, and biological markers, we aim to construct a joint predictive model for MVM-FGR.
详细描述
Clinical guidelines do not recommend clinical screening for MVM-FGR in low-risk populations. Predictive models for FGR are often based on preeclampsia prediction models or Down syndrome serum screening models, which have limited utility. This study aims to establish a multi-center prospective cohort of pregnant women at high risk for FGR. We will collect baseline characteristics of pregnant women, ultrasound measurements of fetal growth, structural scans, maternal-fetal Doppler blood flow, as well as maternal serum and plasma in first and mid-trimester. Serum and plasma biomarker testing will be conducted. We will regularly observe fetal growth data, maternal-fetal complications during pregnancy, and collect delivery information, conditions of the newborn and placental pathology results after birth. By integrating maternal medical history, serum and plasma biomarkers, Doppler ultrasound, and other factors, we will establish a combined predictive model for early and mid-term MVM-FGR.
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
- 否
入选标准
- •Pregnant women with gestational age of <14 weeks
- •Maternal age between 18 and 45 years old
- •With at least one of FGR high risk factors:
- •Maternal age >40 years
- •Nulliparous, Maternal age >38 years
- •Previous pregnancy with FGR, PE or placental abruption
- •Maternal medical history of chronic hypertension, diabetes mellitus, chronic nephritis or autoimmune diseases (such as SLE or APS)
- •Recurrent spontaneous abortion (RSA) > 3 times with unknown causes
- •Or with at least two of the following FGR high risk factors:
- •Maternal age 35~40 years
- •BMI ≥ 28 kg/m2 or BMI < 18.5 kg/m2
- •Conception with assisted reproductive technology
- •Interval from previous delivery: > 5 years or < 6 months
排除标准
- •Presence of fetal genetic abnormalities or severe structural abnormalities in prenatal ultrasound or genetic testing.
结局指标
主要结局
Present of maternal-vascular-malperfusion (MVM)-FGR
时间窗: during the pregnancy, up to an average gestational age of 40 weeks
Development of MVM Fetal growth restriction
次要结局
- Other adverse pregnancy outcome(pregnancy-born after 28 days)
- GA at delivery, birth weight, neonatal outcomes.(the day at birth)
研究者
Luming Sun
Professor
Shanghai First Maternity and Infant Hospital
