Pregnancy Clinical Trial
Official title:
Diagnosis and Management of Intrauterine Growth Restriction, Structural Anomalies and Chromosomal Anomalies: A Prospective Cohort Study
The purpose of this prospective cohort study is to build a large platform that includes clinical information (prenatal diagnosis and postnatal follow-up data) and biological specimen banks of fetuses/infants with IUGR or congenital anomalies, which provide vital support and research foundation for accurate diagnosis, precision treatment and meticulous management.
Intrauterine growth restriction (IUGR) and congenital anomalies are one of the important
reasons for infant and childhood death, which carry a high burden to affected individuals and
their families. The detection rates are increasing with the improving diagnostic techniques.
There are several cohorts mentioning the screening of these diseases during pregnancy.
However, at present there have been no reported relevant cohorts that study from intrauterine
to extrauterine period to understand and research the occurrence and development of IUGR and
congenital anomalies as well as the relationship between IUGR and the presence of congenital
anomalies. So in this study, the investigators aim to conduct large-sample prospective cohort
study based on clinical data and biological samples to observe the occurrences, progression
and clinical outcomes of IUGR and congenital anomalies, and investigate factors, pathogenesis
and prognostic biomarkers of these diseases. These results can play an important role in
preventing the occurrence of IUGR and congenital anomalies, promoting prognosis and guiding
the clinical treatments.
All pregnant women or neonates/infants who present to Guangzhou Women and Children's Medical
Center with the diagnoses of IUGR or congenital anomalies (including congenital malformation,
deformations, disruptions, dysplasia and chromosomal anomalies) are eligible to participate
in the study. Investigators will use routine obstetrical ultrasound to evaluate the growths
and developments of fetuses during pregnancy. Investigators will collect dietary habits,
exposures (the usage of medicine, exposure to contaminants), maternal history and history of
disease, imaging data from the pregnant women who are prenatally diagnosed with fetus having
IUGR or congenital anomalies. Afterbirth, the neonates will receive appropriate treatment.
Regular physical and neural development examination with a pediatrician to measure growth and
development that has taken place. Data regarding diagnosis, treatment, growth and development
will be collected by intelligent data extraction platforms. Machine learning and statistical
analysis are used to build the diagnostic prediction models to improve the accuracy of
prenatal diagnosis of IUGR and congenital anomalies. In addition, the investigators will
estimate the burden on individuals and families by evaluating the associations between
interventions during pregnancy and after birth and clinical outcomes such as adverse events,
length of hospitalization, hospitalization expenses in abnormal children.
In particular, maternal blood, placenta, cord blood, child' blood, urine, stool and tissue
and other specimens during hospitalization and outpatient clinical visit will be collected
and stored in the biospecimen bank. biospecimen bank is managed by special accounts to ensure
the correct and ethical usage of specimens. Investigators hope to identify some markers that
impact the prognosis of IUGR and congenital anomalies by analyzing the prenatal and postnatal
serologic data. Genetic testing will be done on some fetuses to help identify the
pathogenesis and the most appropriate treatment.
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