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临床试验/NCT07433465
NCT07433465已完成不适用

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

Zagazig University1 个研究点 分布在 1 个国家目标入组 556 人开始时间: 2022年12月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
556
试验地点
1
主要终点
Success Rate of Diagnostic Regimens in Predicting Gestational Diabetes Mellitus

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
21 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

GDM Group

Pregnant women who develop gestational diabetes mellitus later in pregnancy.

干预措施: Glycemic Markers (Diagnostic Test)

Non GDM Group

Pregnant women who maintain normal glucose tolerance throughout pregnancy.

干预措施: Glycemic Markers (Diagnostic Test)

结局指标

主要结局

Success Rate of Diagnostic Regimens in Predicting Gestational Diabetes Mellitus

时间窗: 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.

次要结局

  • Iron Homeostasis Markers(24-28 weeks gestation)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Bassem Mohamed Talaat Abdelaziz Ali

Assistant Professor of Obestitrics and gynecology

Zagazig University

研究点 (1)

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