An observational study in Congenital Heart Disease, Fetal Heart Disorder and Neonatal Disease, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Assiut University · Observational
This prospective observational study aims to evaluate the agreement between prenatal fetal echocardiographic diagnoses and postnatal diagnoses of congenital heart disease, and to assess the impact of prenatal diagnosis status on neonatal clinical outcomes at Assiut University Hospitals.
Congenital heart disease (CHD) is the most common congenital organ system anomaly. Effective perinatal management requires coordinated care between obstetricians and neonatologists. This prospective observational study will include pregnant women referred for fetal echocardiography due to suspected or confirmed CHD, as well as neonates with prenatally or postnatally confirmed cardiac diagnoses.
The study will compare prenatal and postnatal diagnoses, assess neonatal outcomes including mortality and need for emergency intervention, and evaluate communication pathways between obstetric and neonatal teams regarding fetal cardiac findings.
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
This study's planned enrollment of 115 is close to the median of 119 across 440 observational studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pregnant women referred for fetal echocardiography due to suspected or confirmed congenital heart disease, and neonates with prenatally or postnatally confirmed CHD at Assiut University Hospitals.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion Criteria (Postnatal arm)::
Inclusion Criteria (Prenatal arm):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neonates with prenatally diagnosed CHD managed with structured perinatal care plan
Neonates with CHD first diagnosed postnatally
Neonates with CHD transferred from external centers after birth
Agreement between prenatal and postnatal CHD diagnosis
Proportion of cases with complete agreement between prenatal fetal echocardiographic diagnosis and postnatal confirmed diagnosis of congenital heart disease.
Time frame: Up to 30 days
Neonatal all-cause mortality
Rate of all-cause neonatal mortality (including operative and in-hospital mortality) according to prenatal diagnosis status.
Time frame: Up to 30 days
Rate of unplanned emergency cardiac intervention
Proportion of neonates requiring unplanned emergency cardiac intervention versus planned elective intervention.
Time frame: Up to 30 days
Duration of NICU stay
Length of stay in the neonatal intensive care unit (days)
Time frame: Up to 30 days
Need for emergency delivery room intervention
Proportion of neonates requiring emergency intubation, PGE1 initiation, or CPR in the delivery room.
Time frame: Baseline
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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