A Cohort of Severe Placental Fetal Growth Restriction (CoSFGR)

Study Overview
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Brief Summary
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Through multicenter study, the investigators aim to refine the process for precise prenatal diagnosis of fetal growth restriction (FGR), establish a cohort for severe maternal vascular malperfusion (MVM)-FGR, and conduct follow-up study to identify prognostic factors associated with both short-term and long-term outcomes.

Detailed Description
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FGR refers to the inadequate growth of the fetus due to various pathological factors, and is a major cause of morbidity and mortality in neonates, with close link to adverse long-term outcomes. This cohort will based on the establishment of a precise prenatal diagnostic process for FGR, and aims to establish a cohort for severe MVM-FGR. Severe singleton FGR cases (EFW or AC<3%, or EFW<10% with abnormal doppler blood flow) from multiple centers will be included. Prenatal genetic and microbial testing, and ultrasound will be performed to rule out associated fetal factors. Fetal intrauterine status will be closely monitored and assessed during pregnancy, with follow-up studies conducted up to 2 years of age. Pathological examination of the placenta will be conducted after delivery, with genetic testing when necessary.

Official Title
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A Cohort for Severe Placental Fetal Growth Restriction (CoSFGR)

Conditions
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Fetal Growth Restriction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton pregnancy Estimated fetal weight (EFW) or abdominal circumference (AC) < 3rd; or EFW or AC < 10th, combined with abnormal doppler, including uterine artery pulsatility index(UtA PI) >95th percentile, umbilical artery pulsatility index(UA PI) >95th percentile； or umbilical artery absent end-diastolic flow (UA-AEDF) or umbilical artery reversed end-diastolic flow(UA-REDF). provision of signed written informed consent. Exclusion Criteria: Fetus with congenital anomalies; fetus with suspected chromosomal or single gene disorders; fetus with confirmed intrauterine infection (CMV, syphilis and etc.);

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of etiology in severe FGR fetuses | genetic, maternal or placenta | during the pregnancy, up to an average gestational age of 40 weeks | 
| Incidence of perinatal death of MVM-FGR | Incidence of intrauterine Fetal death (IUFD) or neonatal death | death during the pregnancy (average gestational age of 40 weeks), or death in 28 days after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age at birth | Gestational age at birth | the day at birth | 
| Neonatal morbidities | including bronchopulmonary dysplasia, necrotizing enterocolitis,hypoxic ischemic encephalopathy and etc. | pregnancy-born after 28 days | 
| birthweight | birthweight of the neonate | the day at birth | 
| incidence of abnormal neurodevelopment | incidence of any abnormal neurodevelopment diagnosed by doctor. | 2 years after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FGR, MVM, Doppler, placenta