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临床试验/NCT07473739
NCT07473739招募中不适用

Establishment of a Cohort of Maternal Vascular Malperfusion-Related Fetal Growth Restriction (MVM-FGR) Based on an Etiology-Oriented Diagnostic Pathway: Artificial Intelligence-Assisted Multiparametric Ultrasound Prediction of Pregnancy Outcomes

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
pregnancy outcome

研究概览

简要总结

The goal of this prospective cohort study is to enroll pregnancies complicated by placental-related fetal growth restriction (FGR) and to develop predictive models for adverse short- and long-term outcomes. This will be achieved by collecting novel intrauterine monitoring indicators along the fetal brain-placenta-heart axis, combined with conventional fetal surveillance parameters, in order to improve risk stratification and guide clinical management, ultimately improving pregnancy outcomes.

The study will include pregnant women with singleton pregnancies complicated by isolated early-onset placental insufficiency-related FGR, preferably those with abnormal umbilical artery Doppler findings, who elect to continue the pregnancy.

The main question it aims to answer is:

• Whether a predictive model integrating novel intrauterine monitoring indicators along the fetal brain-placenta-heart axis with conventional monitoring parameters can accurately predict perinatal and neonatal adverse outcomes in pregnancies complicated by placental-related 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
20 Years 至 43 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton pregnancy.
  • Isolated early-onset placental insufficiency-related fetal growth restriction (FGR), with priority given to cases with abnormal umbilical artery Doppler flow.
  • Pregnancies in which expectant management is continued.

排除标准

  • Multiple pregnancy complicated by selective fetal growth restriction (sFGR).
  • FGR caused by fetal structural anomalies, genetic abnormalities, or intrauterine infection.
  • Twin pregnancy with intrauterine fetal demise (IUFD) of one fetus.

研究组 & 干预措施

FGR group

干预措施: new ultrasound index and MRI (Other)

结局指标

主要结局

pregnancy outcome

时间窗: during the whole pregnancy and born within 28 days

次要结局

未报告次要终点

研究者

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

Luming Sun

Director, Department of Obstetrics, Center for Prenatal Diagnosis, and Center for Fetal Medicine & Intrauterine Pediatrics; Executive Dean, Fetal Hospital (Preparatory)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

研究点 (1)

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