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临床试验/NCT06096805
NCT06096805招募中不适用

Prediction of Placental Fetal Growth Restriction in High Risk Population (PoPFGR)

Shanghai First Maternity and Infant Hospital1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2023年8月10日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luming Sun

Professor

Shanghai First Maternity and Infant Hospital

研究点 (1)

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