NCT07473739 AI-Based Ultrasound Prediction of Pregnancy Outcomes in Placental-Related Fetal Growth Restriction (MVM-FGR): A Prospective Cohort Study
| NCT ID | NCT07473739 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
| Condition | Fetal Growth Restriction (FGR) |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2023-01-01 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07473739 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 43 Years, studying Fetal Growth Restriction (FGR). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07473739 currently recruiting?
Yes, NCT07473739 is actively recruiting participants. Contact the research team at luming_sun@163.com for enrollment information.
Where is the NCT07473739 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07473739 clinical trial?
NCT07473739 is sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 300 participants.