Clinical trial NCT03398629: Diagnosis and Management of Intrauterine Growth Restriction and Congenital Anomalies
Official title: Diagnosis and Management of Intrauterine Growth Restriction, Structural Anomalies and Chromosomal Anomalies: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intrauterine Growth Restriction
Fetal Anomaly
Chromosomal Anomalies
Pregnancy
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 10000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes pregnant women present to Guangzhou Women and Children's Medical Center with prenatal diagnosis of IUGR, congenital malformations, deformations, disruptions, dysplasia or chromosomal anomalies; and neonates/infants with conformed IUGR, congenital malformations, deformations, disruptions, dysplasia or chromosomal anomalies.

Brief summary: 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.

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:

1. Intrauterine growth restriction (IUGR)
2. Structural anomaly
3. Chromosomal anomaly

Exclusion Criteria:

1. Pregnant women who don't agree to participate;
2. Pregnant women delivering babies at other hospitals.
3. Prenatally suspected anomalies that are not confirmed by postnatal diagnosis.

Primary outcomes:
measure: Consistency between prenatal and postnatal diagnosis of fetal anomalies
timeFrame: At delivery
measure: Constituent ratio of all types of anomalies among live infants
timeFrame: At delivery
measure: Differences of mortality rates between infants with prenatal diagnosis and those with postnatal diagnosis
timeFrame: up to 1 year
measure: Differences of Kaup's indexes between IUGR infants with prenatal intervention and those with postnatal intervention
timeFrame: up to 1 year
measure: Recovery of organ functions following postnatal management in infants with anomalies
timeFrame: up to 5 years
Secondary outcomes:
measure: Catch-up growth for weight
timeFrame: up to 2 years
measure: Catch-up growth for height
timeFrame: up to 2 years
measure: Neurodevelopment at childhood
timeFrame: at age of 1 year old]
measure: Intelligence quotient
timeFrame: At age of 6 years
measure: Quality of life
timeFrame: At age of 5-12 years
measure: Parental psychological distress after a prenatal or postnatal diagnosis of anomaly.
timeFrame: up to 42 days postpartum
measure: Parental quality of life after a prenatal or postnatal diagnosis of anomaly.
timeFrame: up to 42 days postpartum
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
Study officials:
affiliation: Guangzhou Women and Children's Medical Center
name: Wei Zhong, Master
role: PRINCIPAL_INVESTIGATOR
References: