Prospective Study of Fetal Cardiac Anomalies Detected During Antenatal Fetal Anomaly Scanning at the Fetomaternal Unit, Women's Health Hospital, Assiut University: Detection and Pregnancy Outcomes
Sponsor study identifier
observational
200
0 countries
N/A
Study Start
September 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 10, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 10, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 16, 2026
Actual (reported)September 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 22, 2026
Actual (reported)September 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 10, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
At time of anomaly scan, 18+0 to 22+6 weeks gestation
Frequency of Specific Types of Cardiac Anomalies
At diagnosis, 18+0 to 22+6 weeks and confirmed by fetal echocardiography
Frequency of NICU Admission
From birth to discharge, up to 28 days after birth
Frequency of Neonatal Cardiac Surgery
From birth to 28 days after birth
Frequency of Neonatal Death
From birth to 28 days after birth
Pregnant women undergoing second-trimester anomaly scanning in whom fetal cardiac anomalies are detected or suspected and will be followed for pregnancy and neonatal outcomes.
Pregnant women attending the Fetomaternal Unit for second-trimester anomaly scanning at Women's Health Hospital, Assiut University.
Mostafa H Mohamed, prof
Obstetrics and gynecology Department, Assiut University Hospitals
First Submitted
September 16, 2026
First Posted
September 22, 2026
Study Start
September 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 20, 2027
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 10, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 22, 2026
Record last verified: 2026-09
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