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

February 20, 2026 updated by: Bassem Mohamed Talaat Abdelaziz Ali, Zagazig University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

556

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Al Qalyoubia
      • Banhā, Al Qalyoubia, Egypt, 13511
        • Benha University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pregnant women at the time of their initial pregnancy diagnosis, typically presenting at prenatal or outpatient clinics.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GDM Group
Pregnant women who develop gestational diabetes mellitus later in pregnancy.
Diagnostic test: Glycemic Markers
Fasting blood glucose (FBG), 2-h Post postprandial blood glucose (PPBG), HbA1c, and Fasting Serum Insulin (FSI).
Non GDM Group
Pregnant women who maintain normal glucose tolerance throughout pregnancy.
Diagnostic test: Glycemic Markers
Fasting blood glucose (FBG), 2-h Post postprandial blood glucose (PPBG), HbA1c, and Fasting Serum Insulin (FSI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24-28 weeks gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Iron Homeostasis Markers
Time Frame: 24-28 weeks gestation
Levels of serum transferrin and hemoglobin concentration as indicators of insulin resistance and diabetic risk.
24-28 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2022

Primary Completion (Actual)

December 7, 2024

Study Completion (Actual)

October 10, 2025

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC:17.11.2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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