Congenital Heart DefectNCT07832851
Fetal Cardiac Anomalies at Anomaly Scan: Detection and Pregnancy Outcomes - Assiut 2026
An observational study of Congenital Heart Defect and Heart Defects, Congenital, run by Assiut University.
Trial summary
Congenital heart defects are among the most common congenital anomalies and cause significant perinatal morbidity and mortality. Prenatal detection allows counseling, multidisciplinary planning and optimization of delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Congenital Heart Defect, Heart Defects, Congenital
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 10 Feb 2028
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women attending the Fetomaternal Unit for second-trimester anomaly scanning at Women's Health Hospital, Assiut University.
Who may be able to join
- Gestational age between 18+0 and 22+6 weeks at the time of the anomaly scan
- Singleton or multiple pregnancy
- Written informed consent
Who cannot join
- Incomplete essential ultrasound or clinical information
- Cases in which the initial cardiac assessment cannot be completed
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: Prospective Study of Fetal Cardiac Anomalies Detected During Antenatal Fetal Anomaly Scanning at the Fetomaternal Unit, Women's Health Hospital, Assiut University: Detection and Pregnancy Outcomes
Congenital heart defects are among the most common congenital anomalies and cause significant perinatal morbidity and mortality. Prenatal detection allows counseling, multidisciplinary planning and optimization of delivery. This prospective observational cohort study will screen all pregnant women attending the Fetomaternal Unit, Women's Health Hospital, Assiut University for anomaly scan at 18+0 to 22+6 weeks gestation over 12 months. All cases with suspected or detected fetal cardiac anomalies will be consecutively recruited and followed antenatally until delivery and postnatally when possible. Primary outcome is frequency of fetal cardiac anomalies among screened fetuses. Secondary outcomes include frequency of each type of anomaly, NICU admission, need for neonatal cardiac surgery or intervention, and neonatal death. Data will be analyzed using SPSS with descriptive statistics and chi-square or Fisher exact test and t-test or Mann-Whitney as appropriate. P less than 0.05 is considered significant.
Read the detailed description
All eligible pregnant women attending the Fetomaternal Unit for second-trimester anomaly scanning will undergo standardized fetal anatomical and cardiac assessment including situs, cardiac position and axis, four-chamber view, outflow tracts, three-vessel view, three-vessel-trachea view when possible, and cardiac rhythm. Cases with suspected cardiac anomalies will undergo detailed documentation and fetal echocardiography when clinically indicated according to routine practice. They will be counseled and followed with assessment of fetal growth, cardiac function, hydrops and progression. Pregnancy outcomes including gestational age at delivery, mode of delivery, birth weight, Apgar scores, NICU admission, neonatal cardiac intervention and survival will be collected. Postnatal echocardiography will be recorded when available to confirm antenatal diagnosis. The study involves no experimental intervention.
- Conditions
- Congenital Heart Defect, Heart Defects, Congenital
- Keywords
- Fetal cardiac screening, Fetal echocardiography, Congenital heart disease, Anomaly scan, Prenatal diagnosis
- Medical subject headings
- Heart Defects, Congenital
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 |
|---|---|---|
| Single cohort: Pregnant women undergoing anomaly scan | Pregnant women undergoing second-trimester anomaly scanning in whom fetal cardiac anomalies are detected or suspected and will be followed for pregnancy and neonatal outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Fetal Cardiac Anomalies Detected at Anomaly Scan
Proportion of fetuses with cardiac anomalies among all fetuses undergoing anomaly screening at 18+0 to 22+6 weeks. Includes any structural abnormality of heart and great vessels
Measured: At time of anomaly scan, 18+0 to 22+6 weeks gestation
Secondary outcomes (4)
Frequency of Specific Types of Cardiac Anomalies
Number of each type such as VSD, AVSD, Tetralogy of Fallot, TGA, HLHS among affected fetuses
Measured: At diagnosis, 18+0 to 22+6 weeks and confirmed by fetal echocardiography
Frequency of NICU Admission
Number of neonates with cardiac anomalies who require NICU admission
Measured: From birth to discharge, up to 28 days after birth
Frequency of Neonatal Cardiac Surgery
Number of neonates who require cardiac surgery or catheter intervention
Measured: From birth to 28 days after birth
Frequency of Neonatal Death
Number of neonatal deaths within 28 days among neonates with cardiac anomalies
Measured: From birth to 28 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion20 Sep 2027 (estimated)
- Study completion10 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Nasser Rasmy, Assiut University
- Investigators
- Mostafa H Mohamed, prof, Study chair, Obstetrics and gynecology Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832851
- Sponsor's protocol ID
- FetalCardiac-Assiut-2026-29
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Fetal Cardiac Anomalies Detected During Antenatal Fetal Anomaly Scanning at the Fetomaternal Unit, Women's Health Hospital, Assiut University: Detection and Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT07832851
- Acronym / sponsor ID
- FetalCardiac-Assiut-2026-29
- Conditions
- Congenital Heart Defect, Heart Defects, Congenital
- Keywords
- Fetal cardiac screening, Fetal echocardiography, Congenital heart disease, Anomaly scan, Prenatal diagnosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 20 Sep 2027 (estimated)
- Study completion
- 10 Feb 2028 (estimated)
- First posted
- 22 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.
Congenital heart defects are among the most common congenital anomalies and cause significant perinatal morbidity and mortality. Prenatal detection allows counseling, multidisciplinary planning and optimization of delivery. This prospective observational cohort study will screen all pregnant women attending the Fetomaternal Unit, Women's Health Hospital, Assiut University for anomaly scan at 18+0 to 22+6 weeks gestation over 12 months. All cases with suspected or detected fetal cardiac anomalies will be consecutively recruited and followed antenatally until delivery and postnatally when possible. Primary outcome is frequency of fetal cardiac anomalies among screened fetuses. Secondary outcomes include frequency of each type of anomaly, NICU admission, need for neonatal cardiac surgery or intervention, and neonatal death. Data will be analyzed using SPSS with descriptive statistics and chi-square or Fisher exact test and t-test or Mann-Whitney as appropriate. P less than 0.05 is considered significant.
Detailed description
All eligible pregnant women attending the Fetomaternal Unit for second-trimester anomaly scanning will undergo standardized fetal anatomical and cardiac assessment including situs, cardiac position and axis, four-chamber view, outflow tracts, three-vessel view, three-vessel-trachea view when possible, and cardiac rhythm. Cases with suspected cardiac anomalies will undergo detailed documentation and fetal echocardiography when clinically indicated according to routine practice. They will be counseled and followed with assessment of fetal growth, cardiac function, hydrops and progression. Pregnancy outcomes including gestational age at delivery, mode of delivery, birth weight, Apgar scores, NICU admission, neonatal cardiac intervention and survival will be collected. Postnatal echocardiography will be recorded when available to confirm antenatal diagnosis. The study involves no experimental intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort: Pregnant women undergoing anomaly scan | – | –Pregnant women undergoing second-trimester anomaly scanning in whom fetal cardiac anomalies are detected or suspected and will be followed for pregnancy and neonatal outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women attending the Fetomaternal Unit for second-trimester anomaly scanning at Women's Health Hospital, Assiut University.
Key inclusion criteria (3 listed)
- Gestational age between 18+0 and 22+6 weeks at the time of the anomaly scan
- Singleton or multiple pregnancy
- Written informed consent
Key exclusion criteria (2 listed)
- Incomplete essential ultrasound or clinical information
- Cases in which the initial cardiac assessment cannot be completed
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
Frequency of Fetal Cardiac Anomalies Detected at Anomaly Scan
Time frame: At time of anomaly scan, 18+0 to 22+6 weeks gestation
Proportion of fetuses with cardiac anomalies among all fetuses undergoing anomaly screening at 18+0 to 22+6 weeks. Includes any structural abnormality of heart and great vessels
4 secondary outcomes
Frequency of Specific Types of Cardiac Anomalies
Time frame: At diagnosis, 18+0 to 22+6 weeks and confirmed by fetal echocardiography
Frequency of NICU Admission
Time frame: From birth to discharge, up to 28 days after birth
Frequency of Neonatal Cardiac Surgery
Time frame: From birth to 28 days after birth
Frequency of Neonatal Death
Time frame: From birth to 28 days after birth
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 22 Sep 2026.
Related trials for Congenital Heart Defect
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
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.
Mostafa H Mohamed, prof study chair
Obstetrics and gynecology Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Defect and Heart Defects, Congenital, 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 3 inclusion and 2 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 22 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 Mina N Rasmy, Resident (01228915300, Mina.18313625@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Fetal Cardiac Anomalies Detected at Anomaly Scan (time frame: At time of anomaly scan, 18+0 to 22+6 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2026.