Perinatal Cardiology: Bridging Obstetric and Neonatal Care in CHD

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Disease Fetal Diseases Fetal Heart Disorder Heart Defects, Congenital Heart Diseases Infant, Newborn, Diseases Neonatal Disease Pregnancy Complications Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Agreement between prenatal and postnatal CHD diagnosis

Time frame: Up to 30 days

Proportion of cases with complete agreement between prenatal fetal echocardiographic diagnosis and postnatal confirmed diagnosis of congenital heart disease.

Secondary outcomes

Neonatal all-cause mortality

Time frame: 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

Time frame: Up to 30 days

Proportion of neonates requiring unplanned emergency cardiac intervention versus planned elective intervention.
Duration of NICU stay

Time frame: Up to 30 days

Length of stay in the neonatal intensive care unit (days)
Need for emergency delivery room intervention

Time frame: Baseline

Proportion of neonates requiring emergency intubation, PGE1 initiation, or CPR in the delivery room.

Study contacts

Contact information is provided by the study sponsor or research team.

Amany A Kamel, Resident

CONTACT

[email protected]

+20 12 00676179

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Sep 15, 2026
Registry last updated: Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed