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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07433465

Enrollment

556

Registered

2026-02-25

Start date

2022-12-05

Completion date

2025-10-10

Last updated

2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

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.

Interventions

DIAGNOSTIC_TESTGlycemic Markers

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 40 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Success Rate of Diagnostic Regimens in Predicting Gestational Diabetes Mellitus	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

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026