Diagnosis and Management of Intrauterine Growth Restriction and Congenital Anomalies

NCT ID: NCT03398629

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2038-03-01

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.

Conditions

Intrauterine Growth Restriction; Fetal Anomaly; Chromosomal Anomalies; Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

IUGR group

Estimated fetal weight below10th percentile for gestational age associated with Abnormal Doppler flow in the umbilical cord (umbilical artery pulsatility index (PI)\>95th percentile).

No interventions assigned to this group

Structural anomaly group

Fetus/neonates/infants who are diagnosed as congenital malformations, deformations, disruptions, dysplasias by ultrasound.

No interventions assigned to this group

Chromosomal anomaly group

Fetus/neonates/infants diagnosed by genetic amniocentesis or chorionic villus sampling for increased risk for fetal aneuploidy or fluorescence in situ hybridization.

No interventions assigned to this group

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Wei Zhong

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wei Zhong, Master

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Women and Children's Medical Center

Locations

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Zhong, Master

Role: CONTACT

zhongwei@gwcmc.org

020-38076288

Facility Contacts

Wei Zhong, Master

Role: primary

zhongwei@gwcmc.org

020-38076288

Other Identifiers

2017120501

Identifier Type: -

Identifier Source: org_study_id