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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GDM Group | Pregnant women who develop gestational diabetes mellitus later in pregnancy. |
| |
| Non GDM Group | Pregnant women who maintain normal glucose tolerance throughout pregnancy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycemic Markers | Diagnostic Test | Fasting blood glucose (FBG), 2-h Post postprandial blood glucose (PPBG), HbA1c, and Fasting Serum Insulin (FSI). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Iron Homeostasis Markers | Levels of serum transferrin and hemoglobin concentration as indicators of insulin resistance and diabetic risk. | 24-28 weeks gestation |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women at the time of their initial pregnancy diagnosis, typically presenting at prenatal or outpatient clinics.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha University | Banhā | Al Qalyoubia | 13511 | Egypt |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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