Diagnosis and Management of Intrauterine Growth Restriction and Congenital Anomalies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorGuangzhou Women and Children's Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Intrauterine growth restriction (IUGR)
Structural anomaly
Chromosomal anomaly
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
10,000 Participants
are grouped into 3 trial groupsGroup A: IUGR group
Group B: Structural anomaly group
Group C: Chromosomal anomaly group
Trial outcomes
Primary outcomes
1
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.
Time frame
At delivery2
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.
Time frame
At delivery3
Differences of mortality rates between infants with prenatal diagnosis and those with postnatal diagnosis
Time frame
up to 1 year4
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
Time frame
up to 1 yearSecondary outcomes
1
Catch-up growth for weight
Weight was measured in infants at 4, 6, 9, 12, 15, 18, 21 and 24 months after birth.
Time frame
up to 2 years2
Catch-up growth for height
Height was measured in infants at 4, 6, 9, 12, 15, 18, 21 and 24 months after birth.
Time frame
up to 2 years3
Neurodevelopment at childhood
Including adaptive, gross motor, fine motor, language and personal-social, assessed by Gesell Developmental Schedules.
Time frame
at age of 1 year old]4
Intelligence quotient
Assessed using Wechsler's Intelligence Scale for Children-Ⅳ(WISC-Ⅳ) consisting of verbal test and performance test. Verbal test covers the following areas: information, vocabulary, arithmetic, comprehension and similarities; Performance test includes picture completion, picture arrangement, block design, object assembly and coding. Each subscale scores range: 1 to 19. Higher scores indicate better performance. A total score is computed by summing the 10 subscale scores. Full-scale intelligence quotients is calculated based on the Wechsler's Intelligence Scale for Children-Ⅳ total score according to instructions. It ranges from 40 to 160, in which under 70 is defined as mental retardation.
Time frame
At age of 6 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov