About this trial
Congenital heart defects are among the most common congenital anomalies and cause significant perinatal morbidity and mortality. Prenatal detection allows counseling, multidisciplinary planning and optimization of delivery. This prospective observational cohort study will screen all pregnant women attending the Fetomaternal Unit, Women's Health Hospital, Assiut University for anomaly scan at 18+0 to 22+6 weeks gestation over 12 months. All cases with suspected or detected fetal cardiac anomalies will be consecutively recruited and followed antenatally until delivery and postnatally when possible. Primary outcome is frequency of fetal cardiac anomalies among screened fetuses. Secondary outcomes include frequency of each type of anomaly, NICU admission, need for neonatal cardiac surgery or intervention, and neonatal death. Data will be analyzed using SPSS with descriptive statistics and chi-square or Fisher exact test and t-test or Mann-Whitney as appropriate. P less than 0.05 is considered significant.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Gestational age between 18+0 and 22+6 weeks at the time of the anomaly scan
Singleton or multiple pregnancy
Written informed consent
Disqualifiers
Incomplete essential ultrasound or clinical information
Cases in which the initial cardiac assessment cannot be completed
Trial population
Pregnant women attending the Fetomaternal Unit for second-trimester anomaly scanning at Women's Health Hospital, Assiut University.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Frequency of Fetal Cardiac Anomalies Detected at Anomaly Scan
Proportion of fetuses with cardiac anomalies among all fetuses undergoing anomaly screening at 18+0 to 22+6 weeks. Includes any structural abnormality of heart and great vessels
Secondary outcomes
Frequency of Specific Types of Cardiac Anomalies
Number of each type such as VSD, AVSD, Tetralogy of Fallot, TGA, HLHS among affected fetuses
Frequency of NICU Admission
Number of neonates with cardiac anomalies who require NICU admission
Frequency of Neonatal Cardiac Surgery
Number of neonates who require cardiac surgery or catheter intervention
Frequency of Neonatal Death
Number of neonatal deaths within 28 days among neonates with cardiac anomalies
Locations
Sponsors and contacts
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