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NCT Number: NCT07473739

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

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.

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Key information

Conditions

Fetal Growth Restriction (FGR) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

20 year–43 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Shanghai, 200092, China

Location status: Recruiting

Location contact

Luming Sun, Prof

CONTACT

[email protected]

+86 18321625166

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

new ultrasound index and MRI

Other

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
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
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

Primary outcomes

pregnancy outcome

Time frame: during the whole pregnancy and born within 28 days

Study contacts

Contact information is provided by the study sponsor or research team.

Luming Sun, Prof

CONTACT

[email protected]

+86 18321625166

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2028
First posted: Mar 16, 2026
Registry last updated: Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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