Establishment of Reference Intervals for Iron Test Panel for Pregnant Women at Hung Vuong Hospital
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Reference Intervals for Iron Biomarkers in the First Trimester
研究概览
简要总结
This cross-sectional study aims to establish reference intervals for iron biomarkers-including serum iron, ferritin, total iron-binding capacity (TIBC), and transferrin saturation (TSAT)-in healthy pregnant women during the first trimester. Additionally, the study will investigate the current prevalence of non-anemic iron deficiency (NAID) in this population. By applying strict inclusion and exclusion criteria to eliminate potential confounding factors, the study seeks to provide a reliable baseline for evaluating iron status and early detection of iron deficiency without anemia among pregnant women.
详细描述
- Title Reference Intervals of Iron, Ferritin, TIBC, and Transferrin Saturation in First Trimester Pregnant Women and Prevalence of Non-Anemic Iron Deficiency
- Background and Rationale Iron deficiency (ID) is the most common micronutrient deficiency globally and a significant concern during pregnancy. Early identification of iron deficiency-even in the absence of anemia-is essential to prevent adverse maternal and fetal outcomes. However, reference intervals for iron biomarkers in early pregnancy remain inconsistent and vary across populations. Moreover, there is a paucity of data on the prevalence of non-anemic iron deficiency (NAID) during the first trimester, a critical period for fetal development. This study aims to address these gaps.
- Objectives Primary Objective: To determine reference intervals for serum iron, ferritin, TIBC, and TSAT in healthy pregnant women during the first trimester.
Secondary Objective: To estimate the prevalence of non-anemic iron deficiency (NAID), defined as low iron biomarkers with normal hemoglobin (Hb ≥ 11 g/dL). 4. Study Design Type: Cross-sectional observational study Setting: Antenatal care clinics at Hung Vuong Hospital, Ho Chi Minh city, Vietnam Duration: From March to June, 2025 (anticipated) 5. Study Population Inclusion Criteria
- Pregnant women in the first trimester (gestational age ≤ 13 weeks 6 days).
- Carrying a single live fetus.
- Hemoglobin ≥ 11 g/dL at the time of enrollment.
- Systolic blood pressure < 140 mmHg and diastolic < 90 mmHg.
- Body temperature > 35°C and < 37.5°C at time of examination.
- Attending routine antenatal care and willing to participate. Exclusion Criteria
- History of:
Diabetes mellitus, hypertension, hemoglobinopathies, leukemia, non-hematologic malignancies, systemic lupus erythematosus. Gastrointestinal disorders affecting iron absorption (e.g., Celiac disease, Crohn's disease, ulcerative colitis, gastric surgery).
- Current use of acid-suppressing medications (PPIs, H2 blockers).
- Positive screening for Treponema pallidum, HBsAg, or HIV.
- Use of stimulants or tobacco smoking.
- Sample Size A minimum of 120 participants is recommended for establishing reference intervals per CLSI guidelines (C28-A3), with oversampling to account for exclusions and incomplete data.
- Data Collection Clinical Data
- Maternal age, gestational age, BMI
- Vital signs (BP, temperature)
- Medical and obstetric history Laboratory Investigations
- Hemoglobin (Hb)
- Serum iron
- Ferritin
- Total iron-binding capacity (TIBC)
- Transferrin saturation (TSAT) = (Serum iron / TIBC) × 100
- Statistical Analysis Reference Intervals
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women attending antenatal care, carrying a single live fetus.
- •Systolic blood pressure at the time of examination < 140 mmHg.
- •Diastolic blood pressure at the time of examination < 90 mmHg.
- •Body temperature at the time of examination between >35°C and <37.5°C.
- •Hemoglobin ≥ 11 g/dL
排除标准
- •History of diabetes mellitus, hypertension, hemoglobinopathies, leukemia, non-hematologic cancers, systemic lupus erythematosus, Gastrointestinal diseases (Celiac disease, Crohn's disease and ulcerative colitis, Gastric diseases or prior gastrointestinal surgery, Irritable bowel syndrome, etc).
- •Currently on gastric acid-suppressing medications: Proton pump inhibitors (e.g., Omeprazole, Lansoprazole, Esomeprazole...), H2 receptor antagonists (e.g., Ranitidine, Famotidine, Cimetidine...), Positive screening for Treponema pallidum, HBsAg, or HIV.
- •Use of stimulants or tobacco smoking.
结局指标
主要结局
Reference Intervals for Iron Biomarkers in the First Trimester
时间窗: At baseline (upon enrollment)
Establish reference intervals (2.5th-97.5th percentile) for serum iron, ferritin, TIBC, and TSAT in healthy first-trimester pregnant women meeting inclusion criteria
Prevalence of iron supplement using women that has non-anemic iron deficiency in the first trimester
时间窗: At baseline (upon enrollment)
Non-anemic iron deficiency is defined as hemoglobin ≥ 11 g/dL and transferrin saturation (TSAT) \< 20%. The prevalence will be calculated as the proportion of enrolled pregnant women meeting these criteria
Prevalence of non iron supplement using women that has non-anemic iron deficiency in the first trimester
时间窗: At baseline (upon enrollment)
Non-anemic iron deficiency is defined as hemoglobin ≥ 11 g/dL and transferrin saturation (TSAT) \< 20%. The prevalence will be calculated as the proportion of enrolled pregnant women meeting these criteria
次要结局
未报告次要终点
研究者
Huan Nguyen Pham
Doctor
Hung Vuong Hospital