ClinicalTrials.gg
Not yet recruitingNCT07832851Updated Sep 22, 2026

Fetal Cardiac Anomalies at Anomaly Scan: Detection and Pregnancy Outcomes - Assiut 2026

An observational study in Congenital Heart Defect and Heart Defects, Congenital, sponsored by Assiut University. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Assiut University · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 26 studies in Heart Defects, Congenital by Assiut University — 16 open to participants now, 16 under way, none of them phase 3. Heart Defects, Congenital · Assiut University.

Planned enrollment
Largest of 20
200 · median 75
Started
2026
with 6 others
Observational
20 of 26
15 open now
Primary completion
2027-09
later than 11 of 15 live
Registered
24th of 26
by date

Among the 26 studies in Heart Defects, Congenital by Assiut University, this one has the largest planned enrollment of the 20 observational ones that give a count, is one of 7 that started in 2026, is one of 20 observational ones, reaches primary completion later than 11 of the 15 other live ones, and was the 24th registered.

Heart Defects, Congenital

991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.

Browse Heart Defects, Congenital studies →

Open to participants now

16 of the 26 studies in Heart Defects, Congenital by Assiut University are open now, in 1 country. Recruiting first, the newest first:

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By country, each count listing its studies:

All 16 open studies →

Where they have run

Who these studies take

Of the 154 Heart Defects, Congenital studies recruiting now, 67 (44%) set no upper age limit and 79 (51%) stop at 75 or younger; 110 take children under 18; 25 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

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02

Study 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. 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.

03

Conditions studied

  • Congenital Heart Defect
  • Heart Defects, Congenital

Keywords

  • Fetal cardiac screening
  • Fetal echocardiography
  • Congenital heart disease
  • Anomaly scan
  • Prenatal diagnosis
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pregnant women attending the Fetomaternal Unit for second-trimester anomaly scanning at Women's Health Hospital, Assiut University.

Eligibility criteria

Inclusion Criteria:-

  • Gestational age between 18+0 and 22+6 weeks at the time of the anomaly scan
  • Singleton or multiple pregnancy
  • Written

Exclusion Criteria:

  • Incomplete essential ultrasound or clinical information
  • Cases in which the initial cardiac assessment cannot be completed
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: At time of anomaly scan, 18+0 to 22+6 weeks gestation

Secondary outcomes

  1. Frequency of Specific Types of Cardiac Anomalies

    Number of each type such as VSD, AVSD, Tetralogy of Fallot, TGA, HLHS among affected fetuses

    Time frame: At diagnosis, 18+0 to 22+6 weeks and confirmed by fetal echocardiography

  2. Frequency of NICU Admission

    Number of neonates with cardiac anomalies who require NICU admission

    Time frame: From birth to discharge, up to 28 days after birth

  3. Frequency of Neonatal Cardiac Surgery

    Number of neonates who require cardiac surgery or catheter intervention

    Time frame: From birth to 28 days after birth

  4. Frequency of Neonatal Death

    Number of neonatal deaths within 28 days among neonates with cardiac anomalies

    Time frame: From birth to 28 days after birth

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

Of 178 non-industry observational studies under Heart Defects, Congenital, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 83. This study's planned 12 months is below that.

Counting every sponsor, half of 185 studies reached it within 44 months; a quarter within 17 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2026
First posted
Sep 22, 2026
StartEst.
Sep 20, 2026
Primary completionEst.
Sep 20, 2027
CompletionEst.
Feb 10, 2028
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07832851
Lead sponsor
Assiut University
Responsible party
Mina Nasser Rasmy (Resident Physician, Assiut University) — Principal investigator
First posted
Sep 22, 2026
Start date
Sep 20, 2026 (estimated)
Primary completion
Sep 20, 2027 (estimated)
Completion
Feb 10, 2028 (estimated)
Last update
Sep 22, 2026

Study contacts

Mina N Rasmy, Resident
Contact
Mina.18313625@med.aun.edu.eg
01228915300
Mostafa H Mohamed, prof
study chair · Obstetrics and gynecology Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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