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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAssiut University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Single cohort: Pregnant women undergoing anomaly scan

Trial outcomes

Primary outcomes

1

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

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

Secondary outcomes

1

Frequency of Specific Types of Cardiac Anomalies

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

Time frame
At diagnosis, 18+0 to 22+6 weeks and confirmed by fetal echocardiography
2

Frequency of NICU Admission

Number of neonates with cardiac anomalies who require NICU admission

Time frame
From birth to discharge, up to 28 days after birth
3

Frequency of Neonatal Cardiac Surgery

Number of neonates who require cardiac surgery or catheter intervention

Time frame
From birth to 28 days after birth
4

Frequency of Neonatal Death

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

Time frame
From birth to 28 days after birth

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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