Actively Recruiting
A Cohort of Maternal Vascular Malperfusion-related Fetal Growth Restriction (CoMVMFGR)
Led by Shanghai First Maternity and Infant Hospital · Updated on 2024-06-07
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are establishing a multicenter cohort study focusing on placenta-mediated fetal growth restriction (FGR), specifically maternal vascular malperfusion-related FGR (MVM-FGR). This condition involves the fetus not reaching its genetic growth potential due to various pathological factors, and it is linked to significant health risks during and after pregnancy. The study aims to identify early and long-term indicators of adverse outcomes related to MVM-FGR to improve intervention and prevention strategies. The study enrolls singleton pregnancies diagnosed with MVM-FGR based on strict diagnostic criteria aligned with the FIGO consensus. Participants undergo prenatal screenings for genetic abnormalities, infections, and structural anomalies. Techniques such as Doppler ultrasound, magnetic resonance imaging (MRI), and electronic fetal heart monitoring are used to assess fetal health. After delivery, the placenta is examined pathologically, with genetic testing performed if needed. The follow-up period extends until the child reaches two years of age. Participants will be monitored throughout pregnancy and postpartum to collect detailed data on fetal and maternal health. Researchers will track short-term and long-term outcomes associated with MVM-FGR, including mortality during pregnancy and within 28 days after birth. They will also study genetic causes of FGR and maternal complications after 28 days postpartum. This comprehensive monitoring includes imaging, genetic testing, and clinical assessments to build a predictive model for adverse outcomes.
CONDITIONS
Brief Title
A Cohort of Maternal Vascular Malperfusion-related FGR (CoMVMFGR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Singleton pregnancy
- Diagnosed with fetal growth restriction (FGR) according to Delphi consensus criteria
- Early-onset FGR diagnosed before 32 weeks with specific ultrasound and Doppler findings
- Late-onset FGR diagnosed at or after 32 weeks with defined ultrasound and Doppler criteria
- Able to provide signed written informed consent
- Female participants aged 18 to 45 years
You will not qualify if you...
- Fetus with confirmed genetic disorders related to FGR
- Fetus with confirmed intrauterine infections such as CMV or syphilis
- Fetus with structural anomalies
- Incomplete information or absence of informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until diagnosis is confirmed, typically within pregnancy duration
Participants undergo diagnostic procedures including Doppler ultrasound, MRI, and electronic fetal heart monitoring to assess fetal condition and confirm maternal vascular malperfusion-related fetal growth restriction (MVM-FGR).
Multiple visits depending on assessment schedule
Duration - Up to 2 years postpartum
Participants and their children are followed up until the child reaches two years of age postpartum to assess short-term and long-term outcomes related to MVM-FGR.
Periodic visits throughout pregnancy and up to 2 years after birth
Trial Site Locations
Total: 1 location
1
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, China, 201204
Actively Recruiting
Research Team
J
Jianping Chen, Master
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Frequently Asked Questions
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