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

NCT07433465 | Completed

• 1 other identifier: RC:17.11.2022
• Study Type: observational
• Target: 556
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Success Rate of Diagnostic Regimens in Predicting Gestational Diabetes Mellitus

  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 Outcomes (1)

• Iron Homeostasis Markers

  24-28 weeks gestation

Study Arms (2)

GDM Group

Pregnant women who develop gestational diabetes mellitus later in pregnancy.

Diagnostic Test: Glycemic Markers

Non GDM Group

Pregnant women who maintain normal glucose tolerance throughout pregnancy.

Diagnostic Test: Glycemic Markers

Interventions

Glycemic Markers DIAGNOSTIC_TEST

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

GDM Group; Non GDM Group

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Benha University

Banhā, Al Qalyoubia, 13511, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples were drawn aseptically from the antecubital vein for molecular and biochemical analysis. Sample Types \& Collection: Fluoride-containing tubes: Used for blood samples intended for Fasting Blood Glucose (FBG) and 2-hour postprandial blood glucose (PPBG) estimation. EDTA-containing tubes: Used for blood samples intended for HbA1c estimation. Serum Processing: Blood was collected in clean tubes, allowed to clot, and centrifuged at 1000 rpm for 10 minutes to separate the serum. Storage Conditions: Serum Storage: Samples were kept frozen at -20 °C for the later estimation of insulin, ferritin, iron, and Total Iron-Binding Capacity (TIBC) via ELISA. Laboratory Parameters Measured: Glycemic Markers: FBG, 2-h PPBG, HbA1c, and Fasting Serum Insulin (FSI). Iron Indices: Serum ferritin, serum iron, TIBC, transferrin saturation (TF), and hemoglobin concentration

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obestitrics and gynecology

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 25, 2026
• Study Start: December 5, 2022
• Primary Completion: December 7, 2024
• Study Completion: October 10, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

EG (1)