Gestatiaonl Diabetes MellitusNCT07312838
Evaluation of Glycemic Impact on Fetal Liver Length and Volume by Ultrasound in Pregnancy
An observational study of Gestatiaonl Diabetes Mellitus and FETAL LİVER VOLUME, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women only
- Conditions the study is for
- Gestatiaonl Diabetes Mellitus, FETAL LİVER VOLUME
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 28 Mar 2028
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 52 years
- Women only
- Adult
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)
Who may be able to join
- 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
Who cannot join
- preexisting diabetes
- fetal congenital anomalies or chromosomal abnormalities
- maternal chronic illnesses (e.g. Hypertension , thyroid disorders)
- multiple pregnancies
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gestatiaonl Diabetes Mellitus, FETAL LİVER VOLUME
- Keywords
- Ultrasound, Fetal liver length, Fetal liver volume, Gestational diabetes mellitus
- Medical subject headings
- Diabetes, Gestational
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of fetal liver length with maternal glycemic state
Correlation of fetal liver length with maternal glycemic state
Measured: 12 weeks
Comparison of fetal liver length
Comparison of fetal liver length between women with gestational diabetes mellitus (GDM) and normoglycemic pregnancies.
Measured: 12 weeks
Correlation of fetal liver volume with maternal glycemic state
Correlation of fetal liver volume with maternal glycemic state
Measured: 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.
Measured: 12 weeks
Secondary outcomes (4)
Correlation of fetal liver size with standard fetal biometry
Correlation of fetal liver size with standard fetal biometry (abdominal circumference, estimated fetal weight).
Measured: 12 weeks
Relationship of fetal liver measurements with neonatal outcomes
Relationship of fetal liver measurements with neonatal outcomes (birth weight, macrosomia, neonatal hypoglycemia
Measured: 12 weeks
Comparison of abdominal circumference with fetal liver volume
Comparison of abdominal circumference with fetal liver volume
Measured: 12 weeks
Comparison of abdominal circumference with fetal liver length
Comparison of abdominal circumference with fetal liver length
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion28 Mar 2028 (estimated)
- Study completion28 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestatiaonl Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yousef Ahmed Mahmoud Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312838
- Sponsor's protocol ID
- Fetal liver parameters by U/S
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of Fetal Liver Length and Volume as Novel Markers of Glycemic Impact in Pregnancy: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07312838
- Acronym / sponsor ID
- Fetal liver parameters by U/S
- Conditions
- Gestatiaonl Diabetes Mellitus, FETAL LİVER VOLUME
- Keywords
- Ultrasound, Fetal liver length, Fetal liver volume, Gestational diabetes mellitus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 28 Mar 2028 (estimated)
- Study completion
- 28 Mar 2028 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Age groups
- Adult
- 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)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- preexisting diabetes
- fetal congenital anomalies or chromosomal abnormalities
- maternal chronic illnesses (e.g. Hypertension , thyroid disorders)
- multiple pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of fetal liver length with maternal glycemic state
Time frame: 12 weeks
Correlation of fetal liver length with maternal glycemic state
Comparison of fetal liver length
Time frame: 12 weeks
Comparison of fetal liver length between women with gestational diabetes mellitus (GDM) and normoglycemic pregnancies.
Correlation of fetal liver volume with maternal glycemic state
Time frame: 12 weeks
Correlation of fetal liver volume with maternal glycemic state
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestatiaonl Diabetes Mellitus and FETAL LİVER VOLUME, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yousef Ahmed Mahmoud Ahmed, Master (+201150003203, yousef.17308818@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of fetal liver length with maternal glycemic state (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.