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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07473739

Enrollment

300

Registered

2026-03-16

Start date

2023-01-01

Completion date

2028-11-30

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Growth Restriction (FGR)

Brief 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.

Interventions

OTHERnew 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 design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 43 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
pregnancy outcome	during the whole pregnancy and born within 28 days

Countries

China

Contacts

CONTACTLuming Sun, Prof

luming_sun@163.com+86 18321625166

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026