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

March 11, 2026 updated by: Luming Sun, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200092
        • Recruiting
        • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine Shanghai, Shanghai, China
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FGR group
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pregnancy outcome
Time Frame: during the whole pregnancy and born within 28 days
during the whole pregnancy and born within 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2028

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-25-008-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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