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

NCT07473739 | Recruiting

• 1 other identifier: XH-25-008-1
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Growth Restriction (FGR)

Outcome Measures

Primary Outcomes (1)

• pregnancy outcome

  during the whole pregnancy and born within 28 days

Study Arms (1)

FGR group

Other: new ultrasound index and MRI

Interventions

new ultrasound index and MRI OTHER

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

FGR group

Eligibility Criteria

• Age: 20 Years - 43 Years
• Gender Eligibility Details: he participants are all pregnant women with FGR fetuses.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, 200092, China

RECRUITING

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Luming Sun, Prof

CONTACT

+86 18321625166; luming_sun@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Obstetrics, Center for Prenatal Diagnosis, and Center for Fetal Medicine & Intrauterine Pediatrics; Executive Dean, Fetal Hospital (Preparatory)

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: January 1, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

CN (1)