- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07832851
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Mina N Rasmy, Resident
- Telefonnummer: 01228915300
- E-mail: Mina.18313625@med.aun.edu.eg
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Pregnant women attending the Fetomaternal Unit for second-trimester anomaly scanning at Women's Health Hospital, Assiut University.
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Frequency of Fetal Cardiac Anomalies Detected at Anomaly Scan
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Frequency of Specific Types of Cardiac Anomalies
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Mostafa H Mohamed, prof, Obstetrics and gynecology Department, Assiut University Hospitals
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FetalCardiac-Assiut-2026-29
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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