Diagnosis and Management of Intrauterine Growth Restriction and Congenital Anomalies

NCT03398629 | Recruiting

• 1 other identifier: 2017120501
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrauterine Growth Restriction; Fetal Anomaly; Chromosomal Anomalies; Pregnancy

Outcome Measures

Primary Outcomes (5)

• Consistency between prenatal and postnatal diagnosis of fetal anomalies

  Comparison of results of prenatal ultrasound or genetic amniocentesis and results of postnatal diagnosis in neonates with anomalies.

  At delivery

• Constituent ratio of all types of anomalies among live infants

  Including constituent ratio of all types of anomalies in prenatal diagnosis and constituent ratio of anomalies confirmed by clinical diagnosis after births.

  At delivery

• Differences of mortality rates between infants with prenatal diagnosis and those with postnatal diagnosis

  up to 1 year

• Differences of Kaup's indexes between IUGR infants with prenatal intervention and those with postnatal intervention

  Kaup's index＝weight(kg)÷height(cm)\^2×10\^4

  up to 1 year

• Recovery of organ functions following postnatal management in infants with anomalies

  up to 5 years

Secondary Outcomes (7)

• Catch-up growth for weight

  up to 2 years

• Catch-up growth for height

  up to 2 years

• Neurodevelopment at childhood

  at age of 1 year old]

• Intelligence quotient

  At age of 6 years

• Quality of life

  At age of 5-12 years

Study Arms (3)

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).

Structural anomaly group

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

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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Women and Children's Medical Center: lead

Study Sites (1)

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510623, China

RECRUITING

MeSH Terms

Conditions

Fetal Growth Retardation; Congenital Abnormalities; Chromosome Disorders

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genetic Diseases, Inborn

Study Officials

• Wei Zhong, Master

  Guangzhou Women and Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Zhong, Master

CONTACT

020-38076288; zhongwei@gwcmc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: January 12, 2018
• Study Start: May 1, 2019
• Primary Completion (Estimated): March 1, 2038
• Study Completion (Estimated): March 1, 2038
• Last Updated: June 4, 2019

Record last verified: 2019-06

Locations

CN (1)