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NCT Number: NCT07312838

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

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Correlation of fetal liver length with maternal glycemic state

    Time frame: 12 weeks

    Correlation of fetal liver length with maternal glycemic state

  2. Comparison of fetal liver length

    Time frame: 12 weeks

    Comparison of fetal liver length between women with gestational diabetes mellitus (GDM) and normoglycemic pregnancies.

  3. Correlation of fetal liver volume with maternal glycemic state

    Time frame: 12 weeks

    Correlation of fetal liver volume with maternal glycemic state

  4. 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.

Secondary outcomes

  1. 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).

  2. 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

  3. Comparison of abdominal circumference with fetal liver volume

    Time frame: 12 weeks

    Comparison of abdominal circumference with fetal liver volume

  4. Comparison of abdominal circumference with fetal liver length

    Time frame: 12 weeks

    Comparison of abdominal circumference with fetal liver length

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Mahmoud Abd-Allah

CONTACT

[email protected]

01061056747

Yousef Ahmed Mahmoud Ahmed, Master

CONTACT

[email protected]

+201150003203

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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