NCT06104748

A Cohort of Maternal Vascular Malperfusion-related FGR (CoMVMFGR)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Shanghai First Maternity and Infant Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Based on a precise diagnostic standard process, through a multicenter study, we will establish a cohort focusing on placenta-mediated fetal growth restriction (FGR). Long-term follow-up will be conducted to seek predictive indicators for short-term and long-term adverse outcomes of maternal vascular malperfusion-related FGR (MVM-FGR).

Detailed description

Fetal Growth Restriction (FGR) denotes the inability of fetal growth to attain its inherent genetic potential due to diverse pathological influences. It stands as a significant determinant of morbidity and mortality during the perinatal phase, intricately linked with adverse long-term consequences. The etiology of FGR is complex, involving maternal, placental/umbilical, and fetal factors. Among these, maternal vascular malperfusion-related FGR (MVM-FGR) emerges as the prevalent subtype, which is considered to have potential for early intervention and prevention. To address this, we will establish a cohort dedicated to MVM-FGR, guided by a stringent diagnostic standard process tailored for FGR. Our objective is to compile a comprehensive dataset of singleton pregnancies diagnosed with MVM-FGR cases through multicenter collaboration. The definition of FGR aligns with the FIGO consensus criteria. We conduct thorough prenatal screenings for fetal factors, including genetic abnormalities, infections, and structural anomalies, subsequently enrolling MVM-FGR cases into our cohort. Techniques including Doppler ultrasound, magnetic resonance imaging (MRI), and electronic fetal heart monitoring will be employed to assess fetal conditions. Follow-up continues until the child reaches the age of two years postpartum. Pathological examination of the placenta is performed after delivery, with additional placental genetic testing if necessary.

Conditions

• MVM-FGR

Timeline

• Start date: 2023-08-10
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2023-10-27
• Last updated: 2024-06-07

Locations

1 site across 1 country: China