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

NCT ID: NCT07312838

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-03-28

Brief Summary

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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

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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.

Conditions

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Gestatiaonl Diabetes Mellitus FETAL LİVER VOLUME

Keywords

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Ultrasound Fetal liver length Fetal liver volume Gestational diabetes mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

52 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Yousef Ahmed Mahmoud Ahmed

Dr. Yousef Ahmed Mahmoud Ahmed

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yousef Ahmed Mahmoud Ahmed, Master

Role: CONTACT

Phone: +201150003203

Email: [email protected]

Mohamed Mahmoud Abd-Allah

Role: CONTACT

Phone: 01061056747

Email: [email protected]

Related Links

Other Identifiers

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Fetal liver parameters by U/S

Identifier Type: -

Identifier Source: org_study_id