Diagnosis and Management of Intrauterine Growth Restriction and Congenital Anomalies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Intrauterine Growth Restriction, Fetal Anomaly, Chromosomal Anomalies, Pregnancy. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Diagnosis and Management of Intrauterine Growth Restriction, Structural Anomalies and Chromosomal Anomalies: A Prospective Cohort Study
Overview
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.
Detailed description
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.
Primary outcome measures
- Consistency between prenatal and postnatal diagnosis of fetal anomalies [Time frame: At delivery]
- Constituent ratio of all types of anomalies among live infants [Time frame: At delivery]
- Differences of mortality rates between infants with prenatal diagnosis and those with postnatal diagnosis [Time frame: up to 1 year]
- Differences of Kaup's indexes between IUGR infants with prenatal intervention and those with postnatal intervention [Time frame: up to 1 year]
- Recovery of organ functions following postnatal management in infants with anomalies [Time frame: up to 5 years]
Secondary outcome measures (7)
- Catch-up growth for weight [Time frame: up to 2 years]
- Catch-up growth for height [Time frame: up to 2 years]
- Neurodevelopment at childhood [Time frame: at age of 1 year old]]
- Intelligence quotient [Time frame: At age of 6 years]
- Quality of life [Time frame: At age of 5-12 years]
- Parental psychological distress after a prenatal or postnatal diagnosis of anomaly. [Time frame: up to 42 days postpartum]
- Parental quality of life after a prenatal or postnatal diagnosis of anomaly. [Time frame: up to 42 days postpartum]
Eligibility criteria
Inclusion criteria
All pregnant women who present to Guangzhou Women and Children's Medical Center meeting one of the following prenatal diagnoses and neonates/infants who are diagnosed as one of the following anomalies will be invited to participate:
- Intrauterine growth restriction (IUGR)
- Structural anomaly
- Chromosomal anomaly
Exclusion criteria
- Pregnant women who don't agree to participate;
- Pregnant women delivering babies at other hospitals.
- Prenatally suspected anomalies that are not confirmed by postnatal diagnosis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Guangzhou Women and Children's Medical Center — Guangzhou
Identifiers
NCT: NCT03398629 · 2017120501