Intrauterine Growth RestrictionNCT03398629
Diagnosis and Management of Intrauterine Growth Restriction and Congenital Anomalies
An observational study of Intrauterine Growth Restriction and Fetal Anomaly, run by Guangzhou Women and Children's Medical Center at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Intrauterine Growth Restriction, Fetal Anomaly, Chromosomal Anomalies
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 1 Mar 2038
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510623
Wei Zhong, Master, 020-38076288, zhongwei@gwcmc.org
About this study
Official title: Diagnosis and Management of Intrauterine Growth Restriction, Structural Anomalies and Chromosomal Anomalies: A Prospective Cohort Study
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.
Read the 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.
- Medical subject headings
- Fetal Growth Retardation, Congenital Abnormalities, Chromosome Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At delivery
Differences of mortality rates between infants with prenatal diagnosis and those with postnatal diagnosis
Measured: 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
Measured: up to 1 year
Recovery of organ functions following postnatal management in infants with anomalies
Measured: up to 5 years
Secondary outcomes (7)
Catch-up growth for weight
Weight was measured in infants at 4, 6, 9, 12, 15, 18, 21 and 24 months after birth.
Measured: up to 2 years
Catch-up growth for height
Height was measured in infants at 4, 6, 9, 12, 15, 18, 21 and 24 months after birth.
Measured: up to 2 years
Neurodevelopment at childhood
Including adaptive, gross motor, fine motor, language and personal-social, assessed by Gesell Developmental Schedules.
Measured: at age of 1 year old]
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.
Measured: At age of 6 years
Quality of life
Assessed using Pediatric Quality of Life Inventory including physical, emotional, social and school scales. Total Scale score = 23 items, Physical Health Summary Score = 8 items, Psychosocial Health Summary Score = 15 items. Each question is answered on the "5-point Likert scale from 0 (never) to 4 (almost always)". Then "items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The mean of the scores on the 100-point scale is then calculated (sum of all items divided by number of items answered). The total score ranges from 0 to 100, and higher scores indicate a better quality of life.
Measured: At age of 5-12 years
Parental psychological distress after a prenatal or postnatal diagnosis of anomaly.
Parental psychological distress was assessed by using Brief Symptom Inventory (53-item-self-report instrument) which consists of nine subscales: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobia, paranoia and psychoticism. Respondents rank each feeling item on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The subscale and total scores are calculated as an average of the relevant items, with higher scores indicating more severe psychopathology. The test scores are reported in terms of standardized area T-scores.
Measured: up to 42 days postpartum
Parental quality of life after a prenatal or postnatal diagnosis of anomaly.
Parental quality of life was assessed by using World Health Organization Quality of Life Scale Brief which consists of four subscales: physical health with 7 items, psychological with 6 items, social relationships with 3 items and environment with 8 items. Each item is rated on a 5-point Likert scale. Each item is scored from 1 to 5 on a response scale. Raw domain scores were transformed to a 4-20 score according to guidelines. The mean score of items within each domain is used to calculate the domain score. After computing the scores, they transformed linearly to a 0-100-scale. A higher score indicates higher quality of life.
Measured: up to 42 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start1 May 2019
- Primary completion1 Mar 2038 (estimated)
- Study completion1 Mar 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Growth RestrictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhong, Guangzhou Women and Children's Medical Center
- Investigators
- Wei Zhong, Master, Principal investigator, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398629
- Sponsor's protocol ID
- 2017120501
- Status last verified
- Jun 2019
- First submitted
- 5 Dec 2017
- Last updated
- 4 Jun 2019
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Management of Intrauterine Growth Restriction, Structural Anomalies and Chromosomal Anomalies: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03398629
- Acronym / sponsor ID
- 2017120501
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Mar 2038 (estimated)
- Study completion
- 1 Mar 2038 (estimated)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Consistency between prenatal and postnatal diagnosis of fetal anomalies
Time frame: 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
Time frame: 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
Time frame: up to 1 year
Differences of Kaup's indexes between IUGR infants with prenatal intervention and those with postnatal intervention
Time frame: 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
Time frame: up to 5 years
7 secondary outcomes
Catch-up growth for weight
Time frame: up to 2 years
Catch-up growth for height
Time frame: up to 2 years
Neurodevelopment at childhood
Time frame: at age of 1 year old]
Intelligence quotient
Time frame: At age of 6 years
Quality of life
Time frame: At age of 5-12 years
Parental psychological distress after a prenatal or postnatal diagnosis of anomaly.
Time frame: up to 42 days postpartum
Parental quality of life after a prenatal or postnatal diagnosis of anomaly.
Time frame: up to 42 days postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Zhong, Master principal investigator
Guangzhou Women and Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Growth Restriction and Fetal Anomaly, run by Guangzhou Women and Children's Medical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhong, Master (020-38076288, zhongwei@gwcmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consistency between prenatal and postnatal diagnosis of fetal anomalies (time frame: At delivery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019; AzTrials last refreshed its copy on 8 Nov 2026.