Understanding and managing growth issues and birth defects in fetuses and infants
Diagnosis and Management of Intrauterine Growth Restriction, Structural Anomalies and Chromosomal Anomalies: A Prospective Cohort Study
Guangzhou Women and Children's Medical Center · NCT03398629
This study is trying to gather information and samples from babies with growth issues or birth defects to see how these conditions develop and what can help improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Guangzhou Women and Children's Medical Center (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT03398629 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a comprehensive platform that collects clinical information and biological specimens from fetuses and infants diagnosed with intrauterine growth restriction (IUGR) or congenital anomalies. By following these cases from prenatal diagnosis through postnatal outcomes, the study seeks to explore the occurrences, progression, and clinical outcomes of these conditions. The research will also investigate potential factors, pathogenesis, and prognostic biomarkers associated with IUGR and congenital anomalies, ultimately aiming to improve diagnosis and treatment strategies. This large-sample prospective cohort study is designed to fill the gap in existing research by linking intrauterine and extrauterine data.
Who should consider this trial
Good fit: Ideal candidates include pregnant women and neonates/infants diagnosed with IUGR or congenital anomalies at Guangzhou Women and Children's Medical Center.
Not a fit: Patients who are pregnant but do not agree to participate or deliver at other hospitals may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and treatment options for infants with growth restrictions and congenital anomalies.
How similar studies have performed: While there have been studies on screening for these conditions, this approach of linking intrauterine and extrauterine data is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Guangzhou Women and Children's Medical Center — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Principal investigator: Wei Zhong, Master — Guangzhou Women and Children's Medical Center
- Study coordinator: Wei Zhong, Master
- Email: zhongwei@gwcmc.org
- Phone: 020-38076288
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Intrauterine Growth Restriction, Fetal Anomaly, Chromosomal Anomalies, Pregnancy