Perinatal Cardiology: Bridging Obstetric and Neonatal Care in CHD

An Attempt of Bridging the Gaps Between Obstetricians and Neonatologists in Congenital Heart Disease Detection and Management at Assiut University Hospitals

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07820163

Enrollment

115

Registered

2026-09-15

Start date

2026-09-02

Completion date

2028-05-25

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease, Fetal Disease, Fetal Heart Disorder, Neonatal Disease

Keywords

Neonatal outcomes, Congenital heart disease, Fetal echocardiography, Perinatal cardiology, Prenatal diagnosis

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

(Postnatal arm):: * \- Term neonates with confirmed critical CHD * Neonates with prenatal CHD diagnosis or postnatal first-time diagnosis * Parental written informed consent Inclusion Criteria (Prenatal arm): * Singleton pregnancies referred for fetal echocardiography between 18 and 36+6 weeks * Suspected cardiac abnormalities on routine obstetric scan * Written informed consent

Exclusion criteria

* \- Multiple gestations * Fetuses with growth restriction (EFW or AC below 3rd percentile) * Premature infants (\<37 weeks) * Neonates with stable CHD not requiring intervention * Incomplete records or loss to follow-up

Design outcomes

Primary

Measure	Time frame	Description
Agreement between prenatal and postnatal CHD diagnosis	Up to 30 days	Proportion of cases with complete agreement between prenatal fetal echocardiographic diagnosis and postnatal confirmed diagnosis of congenital heart disease.

Secondary

Measure	Time frame	Description
Neonatal all-cause mortality	Up to 30 days	Rate of all-cause neonatal mortality (including operative and in-hospital mortality) according to prenatal diagnosis status.
Rate of unplanned emergency cardiac intervention	Up to 30 days	Proportion of neonates requiring unplanned emergency cardiac intervention versus planned elective intervention.
Duration of NICU stay	Up to 30 days	Length of stay in the neonatal intensive care unit (days)
Need for emergency delivery room intervention	Baseline	Proportion of neonates requiring emergency intubation, PGE1 initiation, or CPR in the delivery room.

Contacts

CONTACTAmany A Kamel, Resident

Amani.18313462@med.aun.edu.eg+20 12 00676179

STUDY_CHAIRDuaa M Raafat, prof

Pediatric Department, Assiut University Hospitals

Outcome results