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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Mina N Rasmy, Resident
- Telefonnummer: 01228915300
- E-Mail: Mina.18313625@med.aun.edu.eg
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Pregnant women attending the Fetomaternal Unit for second-trimester anomaly scanning at Women's Health Hospital, Assiut University.
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Frequency of Fetal Cardiac Anomalies Detected at Anomaly Scan
Zeitfenster: 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 |
At time of anomaly scan, 18+0 to 22+6 weeks gestation
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Frequency of Specific Types of Cardiac Anomalies
Zeitfenster: 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 |
At diagnosis, 18+0 to 22+6 weeks and confirmed by fetal echocardiography
|
|
Frequency of NICU Admission
Zeitfenster: From birth to discharge, up to 28 days after birth
|
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
Zeitfenster: From birth to 28 days after birth
|
Number of neonates who require cardiac surgery or catheter intervention |
From birth to 28 days after birth
|
|
Frequency of Neonatal Death
Zeitfenster: From birth to 28 days after birth
|
Number of neonatal deaths within 28 days among neonates with cardiac anomalies |
From birth to 28 days after birth
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Mostafa H Mohamed, prof, Obstetrics and gynecology Department, Assiut University Hospitals
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- FetalCardiac-Assiut-2026-29
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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