Perinatal Cardiology: Bridging Obstetric and Neonatal Care in CHD
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- Term neonates with confirmed critical CHD
Neonates with prenatal CHD diagnosis or postnatal first-time diagnosis
Parental written informed consent
Singleton pregnancies referred for fetal echocardiography between 18 and 36+6 weeks
Disqualifiers
- Multiple gestations
Fetuses with growth restriction (EFW or AC below 3rd percentile)
Premature infants (<37 weeks)
Neonates with stable CHD not requiring intervention
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
115 Participants
are grouped into 3 trial groupsGroup A: Neonates with prenatally diagnosed CHD managed with structured perinatal care plan
Group B: Neonates with CHD first diagnosed postnatally
Group C: Neonates with CHD transferred from external centers after birth
Trial outcomes
Primary outcomes
1
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 daysSecondary outcomes
1
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 days2
Rate of unplanned emergency cardiac intervention
Proportion of neonates requiring unplanned emergency cardiac intervention versus planned elective intervention.
Time frame
Up to 30 days3
Duration of NICU stay
Length of stay in the neonatal intensive care unit (days)
Time frame
Up to 30 days4
Need for emergency delivery room intervention
Proportion of neonates requiring emergency intubation, PGE1 initiation, or CPR in the delivery room.
Time frame
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: