Evaluation of Glycemic Impact on Fetal Liver Length and Volume by Ultrasound in Pregnancy

December 17, 2025 updated by: Yousef Ahmed Mahmoud Ahmed, Assiut University

Ultrasound Evaluation of Fetal Liver Length and Volume as Novel Markers of Glycemic Impact in Pregnancy: A Prospective Cohort Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Maternal hyperglycemia during pregnancy, even at levels below the diagnostic threshold for gestational diabetes mellitus (GDM), is associated with adverse outcomes such as macrosomia, neonatal hypoglycemia, and long-term metabolic risk in offspring. Current clinical assessment of glycemic impact relies primarily on maternal glucose testing, such as the oral glucose tolerance test (OGTT), and indirect fetal anthropometric markers including abdominal circumference or estimated fetal weight . However, these measures may not fully reflect the fetal metabolic response to maternal hyperglycemia . Emerging evidence suggests that the fetal liver is highly sensitive to maternal glycemic status due to its central role in glucose uptake, glycogen storage, and lipid metabolism . Ultrasound studies have demonstrated that fetuses of mothers with GDM often show increased liver length and volume compared with normoglycemic controls, and these changes can occur before overt increases in overall fetal size .Thus, fetal liver measurements may provide an earlier and more direct marker of intrauterine glycemic exposure . Currently, the strategy for evaluating glycemic impact in pregnancy is based on maternal glucose testing and late-gestation fetal growth assessment, which may delay timely intervention . Moreover, there is no widely accepted ultrasound marker that specifically reflects fetal metabolic adaptation to hyperglycemia . The rationale of this research is to evaluate fetal liver length and volume by ultrasound as novel markers of glycemic impact in pregnancy. By establishing their relationship with maternal glycemic status, this study aims to determine whether fetal liver measurements can serve as an early, non-invasive, and practical tool to identify at-risk pregnancies, thereby paving the way for improved monitoring and timely intervention.

Study Type

Observational

Enrollment (Estimated)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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)

Description

Inclusion Criteria:

  1. gestational age 24wks-36wks by an early pregnancy ultrasound exam including CRL length
  2. normal maternal blood sugar levels in early pregnancy
  3. diagnosed as GDM
  4. singleton viable pregnancy
  5. agree to include in study

Exclusion Criteria:

  1. preexisting diabetes
  2. fetal congenital anomalies or chromosomal abnormalities
  3. maternal chronic illnesses (e.g. Hypertension , thyroid disorders)
  4. multiple pregnancies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of fetal liver length with maternal glycemic state
Time Frame: 12 weeks
Correlation of fetal liver length with maternal glycemic state
12 weeks
Comparison of fetal liver length
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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.
Time Frame: 12 weeks
Comparison of fetal liver volume between women with gestational diabetes mellitus (GDM) and normoglycemic pregnancies.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of fetal liver size with standard fetal biometry
Time Frame: 12 weeks
Correlation of fetal liver size with standard fetal biometry (abdominal circumference, estimated fetal weight).
12 weeks
Relationship of fetal liver measurements with neonatal outcomes
Time Frame: 12 weeks
Relationship of fetal liver measurements with neonatal outcomes (birth weight, macrosomia, neonatal hypoglycemia
12 weeks
Comparison of abdominal circumference with fetal liver volume
Time Frame: 12 weeks
Comparison of abdominal circumference with fetal liver volume
12 weeks
Comparison of abdominal circumference with fetal liver length
Time Frame: 12 weeks
Comparison of abdominal circumference with fetal liver length
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

March 28, 2028

Study Completion (Estimated)

March 28, 2028

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Actual)

December 31, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fetal liver parameters by U/S

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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