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Recruiting Observational

AI-Based Ultrasound Prediction of Pregnancy Outcomes in Placental-Related Fetal Growth Restriction (MVM-FGR): A Prospective Cohort Study

NCT07473739 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2023-01-01
Last updated
2026-03-16

Condition(s) studied

Fetal Growth Restriction (FGR)

Investigational drug(s) / intervention(s)

new ultrasound index and MRI

new ultrasound index and MRI: 1. Fetal Growth Measurements (every 2 w after FGR diagnosis): * Initial diagnosis and follow-up visits * BPD/HC/AC/FL * DVP/AFI * Placental thickness * Umbilical cord insertion site 2. Conventional Doppler Measurements (at least every 2 w after FGR diagnosis): * UA-PI * AEDF * REDF * MCA-PI * MCA-PSV * CPR; MCA-PI / UA-PI * DV-PI * Absent a-wave * Reversed a-wave * UtA Doppler * Left PI and presence of left notch * Right PI and presence of right notch 3. Research Ultrasound Assessments * Placental MV-Flow: vascular index (VI) - upper, middle, and lower regions * Fetal heart \- Cardiothoracic ratio (area ratio) \- Myocardial performance index (MPI): LV-MPI RV-MPI \- E/A ratio: Mitral valve (MV-E/A) Tricuspid valve (TV-E/A) * Fetal brain * Development of the Sylvian fissure: present or absent 3.4 Fetal Brain MRI at 28-30 Weeks of Gestation

Study summary

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.

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
43 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • pregnancy outcome — during the whole pregnancy and born within 28 days

Trial sites (1)

FacilityCityRegionStatus
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine Shanghai, Shanghai, China Shanghai China Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07473739 on ClinicalTrials.gov ↗ ← All trials in China