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

Zagazig University

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Diagnostic Test: Glycemic Markers

Study type: Observational

Funder types: Other

Identifiers

NCT07433465

RC:17.11.2022

Details and patient eligibility

About

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.

Enrollment: 556 patients

Sex: Female

Ages: 21 to 40 years old

Volunteers: No 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.

Trial design

556 participants in 2 patient groups

GDM Group

Description:

Pregnant women who develop gestational diabetes mellitus later in pregnancy.

Treatment:

Diagnostic Test: Glycemic Markers

Non GDM Group

Description:

Pregnant women who maintain normal glucose tolerance throughout pregnancy.

Treatment:

Diagnostic Test: Glycemic Markers