An observational study in MVM-FGR, sponsored by Shanghai First Maternity and Infant Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-06-07.
Sponsored by Shanghai First Maternity and Infant Hospital · Observational
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).
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.
Shanghai First Maternity and Infant Hospital is the lead sponsor of 45 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
severe FGR singletons
1.Singleton pregnancy 2. diagnosed as FGR according the delphi consensus:
Late-onset FGR(≥32 weeks) Estimated fetal weight (EFW) or abdominal circumference (AC) \< 3rd; or >2 of the following 3 criteria:
Exclusion Criteria:
short-term and long-term outcomes associated with MVM-FGR
Exploration of short-term and long-term outcomes associated with MVM-FGR, encompassing intrauterine fetal demise, neonatal mortality, and severe neonatal morbidity.
Time frame: during the pregnancy, up to an average gestational age of 40 weeks
predictive model for adverse outcomes
Development of a predictive model for adverse outcomes of MVM-FGR through the integration of maternal and fetal indicators
Time frame: death during the pregnancy (average gestational age of 40 weeks), or death in 28 days after birth
Distribution of genetic etiologies of FGR
Distribution of genetic etiologies of FGR under the standard assessment process.
Time frame: the day at birth
Severe maternal complications
Severe maternal complications in MVM-FGR cohort
Time frame: pregnancy-born after 28 days
Plan to share: Undecided
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Shanghai First Maternity and Infant Hospital