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Recruiting Observational

Diagnosis and Management of Intrauterine Growth Restriction and Congenital Anomalies

NCT03398629 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2019-05-01
Last updated
2019-06-04

Condition(s) studied

Intrauterine Growth RestrictionFetal AnomalyChromosomal AnomaliesPregnancy

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
18 Years
Healthy volunteers
No
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 outcome measure(s)

  • Consistency between prenatal and postnatal diagnosis of fetal anomalies — At delivery
    Comparison of results of prenatal ultrasound or genetic amniocentesis and results of postnatal diagnosis in neonates with anomalies.
  • Constituent ratio of all types of anomalies among live infants — At delivery
    Including constituent ratio of all types of anomalies in prenatal diagnosis and constituent ratio of anomalies confirmed by clinical diagnosis after births.
  • 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 — up to 1 year
    Kaup's index=weight(kg)÷height(cm)\^2×10\^4
  • Recovery of organ functions following postnatal management in infants with anomalies — up to 5 years

Trial sites (1)

FacilityCityRegionStatus
Guangzhou Women and Children's Medical Center Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03398629 on ClinicalTrials.gov ↗ ← All trials in China