An observational study in Gestatiaonl Diabetes Mellitus and FETAL LİVER VOLUME, sponsored by Assiut University. Not yet recruiting. Open to female participants aged 18 Years to 52 Years. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by Assiut University · Observational
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.
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.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's planned enrollment of 115 is below the median of 200 across 269 observational studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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)
Exclusion Criteria:
Correlation of fetal liver length with maternal glycemic state
Correlation of fetal liver length with maternal glycemic state
Time frame: 12 weeks
Comparison of fetal liver length
Comparison of fetal liver length between women with gestational diabetes mellitus (GDM) and normoglycemic pregnancies.
Time frame: 12 weeks
Correlation of fetal liver volume with maternal glycemic state
Correlation of fetal liver volume with maternal glycemic state
Time frame: 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.
Time frame: 12 weeks
Correlation of fetal liver size with standard fetal biometry
Correlation of fetal liver size with standard fetal biometry (abdominal circumference, estimated fetal weight).
Time frame: 12 weeks
Relationship of fetal liver measurements with neonatal outcomes
Relationship of fetal liver measurements with neonatal outcomes (birth weight, macrosomia, neonatal hypoglycemia
Time frame: 12 weeks
Comparison of abdominal circumference with fetal liver volume
Comparison of abdominal circumference with fetal liver volume
Time frame: 12 weeks
Comparison of abdominal circumference with fetal liver length
Comparison of abdominal circumference with fetal liver length
Time frame: 12 weeks
No study locations are listed for this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Assiut University