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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Defects, Congenital; Congenital Heart Defect

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Mina N Rasmy, Resident; Phone Number: 01228915300; Email: Mina.18313625@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women attending the Fetomaternal Unit for second-trimester anomaly scanning at Women's Health Hospital, Assiut University.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: PROSPECTIVE

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Single cohort: Pregnant women undergoing anomaly scan; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Specific Types of Cardiac Anomalies	Number of each type such as VSD, AVSD, Tetralogy of Fallot, TGA, HLHS among affected fetuses	At diagnosis, 18+0 to 22+6 weeks and confirmed by fetal echocardiography
Frequency of NICU Admission	Number of neonates with cardiac anomalies who require NICU admission	From birth to discharge, up to 28 days after birth
Frequency of Neonatal Cardiac Surgery	Number of neonates who require cardiac surgery or catheter intervention	From birth to 28 days after birth
Frequency of Neonatal Death	Number of neonatal deaths within 28 days among neonates with cardiac anomalies	From birth to 28 days after birth

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Mostafa H Mohamed, prof, Obstetrics and gynecology Department, Assiut University Hospitals

Study record dates

Study Major Dates

• Study Start (Estimated): September 20, 2026
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): February 10, 2028

Study Registration Dates

• First Submitted: September 16, 2026
• First Submitted That Met QC Criteria: September 16, 2026
• First Posted (Actual): September 22, 2026

Study Record Updates

• Last Update Posted (Actual): September 22, 2026
• Last Update Submitted That Met QC Criteria: September 16, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Congenital heart disease; Prenatal diagnosis; Anomaly scan; Fetal echocardiography; Fetal cardiac screening
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: FetalCardiac-Assiut-2026-29

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No