Congenital Heart DiseaseNCT07820163
Perinatal Cardiology: Bridging Obstetric and Neonatal Care in CHD
An observational study of Congenital Heart Disease and Fetal Heart Disorder, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease, Fetal Heart Disorder, Neonatal Disease
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2026to 25 May 2028
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- - 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
- Suspected cardiac abnormalities on routine obstetric scan
- Written informed consent
Who cannot join
- - 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Attempt of Bridging the Gaps Between Obstetricians and Neonatologists in Congenital Heart Disease Detection and Management at Assiut University Hospitals
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.
Read the 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.
- Keywords
- Neonatal outcomes, Congenital heart disease, Fetal echocardiography, Perinatal cardiology, Prenatal diagnosis
- Medical subject headings
- Heart Defects, Congenital, Infant, Newborn, Diseases, Fetal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neonates with prenatally diagnosed CHD managed with structured perinatal care plan | Neonates with prenatally diagnosed CHD managed with structured perinatal care plan | |
| Neonates with CHD first diagnosed postnatally | Neonates with CHD first diagnosed postnatally | |
| Neonates with CHD transferred from external centers after birth | Neonates with CHD transferred from external centers after birth |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days
Secondary outcomes (4)
Neonatal all-cause mortality
Rate of all-cause neonatal mortality (including operative and in-hospital mortality) according to prenatal diagnosis status.
Measured: Up to 30 days
Rate of unplanned emergency cardiac intervention
Proportion of neonates requiring unplanned emergency cardiac intervention versus planned elective intervention.
Measured: Up to 30 days
Duration of NICU stay
Length of stay in the neonatal intensive care unit (days)
Measured: Up to 30 days
Need for emergency delivery room intervention
Proportion of neonates requiring emergency intubation, PGE1 initiation, or CPR in the delivery room.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start2 Sep 2026 (estimated)
- Primary completion26 Sep 2027 (estimated)
- Study completion25 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Abd El-Bary Kamel, Assiut University
- Investigators
- Duaa M Raafat, prof, Study chair, Pediatric Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820163
- Sponsor's protocol ID
- Perinatal-CHD-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Patel SR, Michelfelder E. Prenatal Diagnosis of Congenital Heart Disease: The Crucial Role of Perinatal and Delivery Planning. J Cardiovasc Dev Dis. 2024 Mar 31;11(4):108. doi: 10.3390/jcdd11040108.
PubMed 38667726Blazquez-Romero MDV, Mendivil-Carboni M, Sarasquete-Martinez M, Sainz-Agost A, Falo F, De Corato M, Gomez-Benito MJ. Periodic confined cell migration drives partially reversible chromatin reorganization in cancer cell lines. Commun Biol. 2026 Feb 6;9(1):366. doi: 10.1038/s42003-026-09637-4.
PubMed 41652104Esmaeilzadeh Z, Eaton DW, Hosseini N, Zeinabady D. Sealing faults and fluid-induced seismicity. Philos Trans A Math Phys Eng Sci. 2024 Jul 23;382(2275):20230418. doi: 10.1098/rsta.2023.0418. Epub 2024 Jul 1.
PubMed 38910408Li Y, Guan X, Lan T, Zhang ZR, Zhang Y, Jiang S, Li M, Shi FD, Jin WN. The miR-451a facilitates natural killer cell-associated immune deficiency after ischemic stroke. J Cereb Blood Flow Metab. 2025 Jul;45(7):1371-1384. doi: 10.1177/0271678X251321641. Epub 2025 Feb 22.
PubMed 39985210
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Attempt of Bridging the Gaps Between Obstetricians and Neonatologists in Congenital Heart Disease Detection and Management at Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT07820163
- Acronym / sponsor ID
- Perinatal-CHD-Assiut-2026
- Keywords
- Neonatal outcomes, Congenital heart disease, Fetal echocardiography, Perinatal cardiology, Prenatal diagnosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 Sep 2026 (estimated)
- Primary completion
- 26 Sep 2027 (estimated)
- Study completion
- 25 May 2028 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neonates with prenatally diagnosed CHD managed with structured perinatal care plan | – | –Neonates with prenatally diagnosed CHD managed with structured perinatal care plan |
| Neonates with CHD first diagnosed postnatally | – | –Neonates with CHD first diagnosed postnatally |
| Neonates with CHD transferred from external centers after birth | – | –Neonates with CHD transferred from external centers after birth |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- - 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
- Suspected cardiac abnormalities on routine obstetric scan
Key exclusion criteria (5 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Neonatal all-cause mortality
Time frame: Up to 30 days
Rate of unplanned emergency cardiac intervention
Time frame: Up to 30 days
Duration of NICU stay
Time frame: Up to 30 days
Need for emergency delivery room intervention
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 38667726Patel SR, Michelfelder E. Prenatal Diagnosis of Congenital Heart Disease: The Crucial Role of Perinatal and Delivery Planning. J Cardiovasc Dev Dis. 2024 Mar 31;11(4):108. doi: 10.3390/jcdd11040108.
- Background: PubMed 41652104Blazquez-Romero MDV, Mendivil-Carboni M, Sarasquete-Martinez M, Sainz-Agost A, Falo F, De Corato M, Gomez-Benito MJ. Periodic confined cell migration drives partially reversible chromatin reorganization in cancer cell lines. Commun Biol. 2026 Feb 6;9(1):366. doi: 10.1038/s42003-026-09637-4.
- Background: PubMed 38910408Esmaeilzadeh Z, Eaton DW, Hosseini N, Zeinabady D. Sealing faults and fluid-induced seismicity. Philos Trans A Math Phys Eng Sci. 2024 Jul 23;382(2275):20230418. doi: 10.1098/rsta.2023.0418. Epub 2024 Jul 1.
- Background: PubMed 39985210Li Y, Guan X, Lan T, Zhang ZR, Zhang Y, Jiang S, Li M, Shi FD, Jin WN. The miR-451a facilitates natural killer cell-associated immune deficiency after ischemic stroke. J Cereb Blood Flow Metab. 2025 Jul;45(7):1371-1384. doi: 10.1177/0271678X251321641. Epub 2025 Feb 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Duaa M Raafat, prof study chair
Pediatric Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Fetal Heart Disorder, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amany A Kamel, Resident (+20 12 00676179, Amani.18313462@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between prenatal and postnatal CHD diagnosis (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07820163, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.