NCT07312838

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
23mo left

Started Jan 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Jan 2026Mar 2028

First Submitted

Initial submission to the registry

November 24, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 31, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2028

Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

2.2 years

First QC Date

November 24, 2025

Last Update Submit

December 17, 2025

Conditions

Keywords

UltrasoundFetal liver lengthFetal liver volumeGestational diabetes mellitus

Outcome Measures

Primary Outcomes (4)

  • Correlation of fetal liver length with maternal glycemic state

    Correlation of fetal liver length with maternal glycemic state

    12 weeks

  • Comparison of fetal liver length

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

    12 weeks

  • Correlation of fetal liver volume with maternal glycemic state

    Correlation of fetal liver volume with maternal glycemic state

    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.

    12 weeks

Secondary Outcomes (4)

  • Correlation of fetal liver size with standard fetal biometry

    12 weeks

  • Relationship of fetal liver measurements with neonatal outcomes

    12 weeks

  • Comparison of abdominal circumference with fetal liver volume

    12 weeks

  • Comparison of abdominal circumference with fetal liver length

    12 weeks

Eligibility Criteria

Age18 Years - 52 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Yousef Ahmed Mahmoud Ahmed, Master

CONTACT

Mohamed Mahmoud Abd-Allah

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Yousef Ahmed Mahmoud Ahmed

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 31, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

March 28, 2028

Study Completion (Estimated)

March 28, 2028

Last Updated

December 31, 2025

Record last verified: 2025-12