Evaluation of Glycemic Impact on Fetal Liver Length and Volume by Ultrasound in Pregnancy
Ultrasound Evaluation of Fetal Liver Length and Volume as Novel Markers of Glycemic Impact in Pregnancy: A Prospective Cohort Study
1 other identifier
observational
115
0 countries
N/A
Brief Summary
The primary aim of this study is to evaluate whether fetal liver length and volume, as assessed by ultrasound, can serve as reliable markers of the metabolic impact of Gestational Diabetes Mellitus (GDM) on the fetus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2026
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2025
CompletedFirst Posted
Study publicly available on registry
December 31, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 28, 2028
December 31, 2025
December 1, 2025
2.2 years
November 24, 2025
December 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Correlation of fetal liver length with maternal glycemic state
Correlation of fetal liver length with maternal glycemic state
12 weeks
Comparison of fetal liver length
Comparison of fetal liver length between women with gestational diabetes mellitus (GDM) and normoglycemic pregnancies.
12 weeks
Correlation of fetal liver volume with maternal glycemic state
Correlation of fetal liver volume with maternal glycemic state
12 weeks
Comparison of fetal liver volume between women with gestational diabetes mellitus (GDM) and normoglycemic pregnancies.
Comparison of fetal liver volume between women with gestational diabetes mellitus (GDM) and normoglycemic pregnancies.
12 weeks
Secondary Outcomes (4)
Correlation of fetal liver size with standard fetal biometry
12 weeks
Relationship of fetal liver measurements with neonatal outcomes
12 weeks
Comparison of abdominal circumference with fetal liver volume
12 weeks
Comparison of abdominal circumference with fetal liver length
12 weeks
Eligibility Criteria
Deep learning machine This prospective cohort consisted of pregnant women recruited from the antenatal clinics and fetal-medicine unit at Women's Health Hospital at Assiut University , between \[December 2025 - March 2029\]. Participants were enrolled at the time of their routine mid-trimester/anomaly ultrasound (targeted recruitment window 24weeks gestation for mid-trimester measures, with repeat/late scans at 36 weeks when required for longitudinal liver volume assessment)
You may qualify if:
- gestational age 24wks-36wks by an early pregnancy ultrasound exam including CRL length
- normal maternal blood sugar levels in early pregnancy
- diagnosed as GDM
- singleton viable pregnancy
- agree to include in study
You may not qualify if:
- preexisting diabetes
- fetal congenital anomalies or chromosomal abnormalities
- maternal chronic illnesses (e.g. Hypertension , thyroid disorders)
- multiple pregnancies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Yousef Ahmed Mahmoud Ahmed
Study Record Dates
First Submitted
November 24, 2025
First Posted
December 31, 2025
Study Start
January 1, 2026
Primary Completion (Estimated)
March 28, 2028
Study Completion (Estimated)
March 28, 2028
Last Updated
December 31, 2025
Record last verified: 2025-12