Evaluation of Glycemic Impact on Fetal Liver Length and Volume by Ultrasound in Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gestatiaonl Diabetes Mellitus, FETAL LİVER VOLUME. Basic parameters: 18 years — 52 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ultrasound Evaluation of Fetal Liver Length and Volume as Novel Markers of Glycemic Impact in Pregnancy: A Prospective Cohort Study
Overview
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.
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.
Primary outcome measures
- Correlation of fetal liver length with maternal glycemic state [Time frame: 12 weeks]
- Comparison of fetal liver length [Time frame: 12 weeks]
- 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. [Time frame: 12 weeks]
Secondary outcome measures (4)
- Correlation of fetal liver size with standard fetal biometry [Time frame: 12 weeks]
- Relationship of fetal liver measurements with neonatal outcomes [Time frame: 12 weeks]
- Comparison of abdominal circumference with fetal liver volume [Time frame: 12 weeks]
- Comparison of abdominal circumference with fetal liver length [Time frame: 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07312838 · Fetal liver parameters by U/S