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Completed

NCT Number: NCT07433465

Early Pregnancy Serum Ferritin Levels as a Predictor for Gestational Diabetes Mellitus

This prospective study evaluates a target population of pregnant women at the time of pregnancy diagnosis to investigate the predictive value of serum ferritin (SF) levels for the later development of gestational diabetes mellitus (GDM). The intervention involves measuring early-pregnancy SF, transferrin, and hemoglobin levels, alongside HbA1c, and comparing these biomarkers between women who later develop GDM and those who remain normoglycemic. The primary outcome is to assess the success rate of this diagnostic regimen in identifying high-risk individuals, aiming to establish SF as a valuable early biomarker for GDM to enable timely interventions.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Benha University

Banhā, Al Qalyoubia, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed pregnancy at an early gestational age.
  • Provision of clinical and family history (e.g., age, BMI, history of GDM).

Exclusion criteria

  • Pre-existing Type 1 or Type 2 Diabetes Mellitus.
  • Conditions known to significantly alter iron metabolism independent of pregnancy.

Treatment and study plan

Glycemic Markers

Diagnostic Test

Fasting blood glucose (FBG), 2-h Post postprandial blood glucose (PPBG), HbA1c, and Fasting Serum Insulin (FSI).

Primary outcomes

  1. Success Rate of Diagnostic Regimens in Predicting Gestational Diabetes Mellitus

    Time frame: 24-28 weeks gestation

    The efficacy of early pregnancy Serum Ferritin (SF) levels in accurately identifying women who will subsequently meet the diagnostic criteria for GDM.

Secondary outcomes

  1. Iron Homeostasis Markers

    Time frame: 24-28 weeks gestation

    Levels of serum transferrin and hemoglobin concentration as indicators of insulin resistance and diabetic risk.

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

High Serum Ferritin Early in Pregnancy May Predict the Development of Gestational Diabetes Later.

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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