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NCT Number: NCT07832851

Fetal Cardiac Anomalies at Anomaly Scan: Detection and Pregnancy Outcomes - Assiut 2026

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.

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Key information

Conditions

Congenital Heart Defect Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

All eligible pregnant women attending the Fetomaternal Unit for second-trimester anomaly scanning will undergo standardized fetal anatomical and cardiac assessment including situs, cardiac position and axis, four-chamber view, outflow tracts, three-vessel view, three-vessel-trachea view when possible, and cardiac rhythm. Cases with suspected cardiac anomalies will undergo detailed documentation and fetal echocardiography when clinically indicated according to routine practice. They will be counseled and followed with assessment of fetal growth, cardiac function, hydrops and progression. Pregnancy outcomes including gestational age at delivery, mode of delivery, birth weight, Apgar scores, NICU admission, neonatal cardiac intervention and survival will be collected. Postnatal echocardiography will be recorded when available to confirm antenatal diagnosis. The study involves no experimental intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

  • Gestational age between 18+0 and 22+6 weeks at the time of the anomaly scan
  • Singleton or multiple pregnancy
  • Written informed consent

Exclusion criteria

  • Incomplete essential ultrasound or clinical information
  • Cases in which the initial cardiac assessment cannot be completed

Treatment and study plan

Primary outcomes

  1. Frequency of Fetal Cardiac Anomalies Detected at Anomaly Scan

    Time frame: At time of anomaly scan, 18+0 to 22+6 weeks gestation

    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

  1. Frequency of Specific Types of Cardiac Anomalies

    Time frame: At diagnosis, 18+0 to 22+6 weeks and confirmed by fetal echocardiography

    Number of each type such as VSD, AVSD, Tetralogy of Fallot, TGA, HLHS among affected fetuses

  2. Frequency of NICU Admission

    Time frame: From birth to discharge, up to 28 days after birth

    Number of neonates with cardiac anomalies who require NICU admission

  3. Frequency of Neonatal Cardiac Surgery

    Time frame: From birth to 28 days after birth

    Number of neonates who require cardiac surgery or catheter intervention

  4. Frequency of Neonatal Death

    Time frame: From birth to 28 days after birth

    Number of neonatal deaths within 28 days among neonates with cardiac anomalies

Study contacts

Contact information is provided by the study sponsor or research team.

Mina N Rasmy, Resident

CONTACT

[email protected]

01228915300

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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