Effect of Anemia Intervention Timing (Preconception vs. First Trimester) on the Control of Iron Deficiency Anemia in the Third Trimester: A Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 960
- 试验地点
- 1
- 主要终点
- Proportion of participants with iron deficiency anemia during late pregnancy
研究概览
简要总结
This cluster randomized trial compares preconception with early-pregnancy anemia screening and iron supplementation, assessing late pregnancy iron deficiency anemia and maternal and infant outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The trial is open label for participants, care providers, and investigators. Outcome assessors will be blinded to cluster allocation.
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
- •Women aged 18-45 years
- •Residence in a participating township
- •Intention to attempt natural conception within 6 months after enrollment
- •Ability to complete the required study procedures
- •Ability and willingness to provide written informed consent
排除标准
- •1.Non-iron deficiency anemia or other hematologic disorders: thalassemia, sickle cell anemia, anemia of chronic disease, and other hematologic conditions will be excluded based on complete blood count findings (including hemoglobin concentration) in combination with questionnaire assessment. Renal insufficiency (eGFR <45 mL/min/1.73 m²)
- •2: hepatic insufficiency (ALT or AST >3 times the upper limit of normal)
- •3: uncontrolled heart disease (New York Heart Association [NYHA] functional class III-IV) Acute or chronic infections, including HIV infection, active tuberculosis, and uncontrolled hepatitis B Multiple pregnancy
- •4: current pregnancy complicated by major fetal malformations or chromosomal abnormalities
- •5: history or current diagnosis of preeclampsia, placental abruption, or placenta previa History of hypersensitivity to intravenous iron therapy or iron overload disorders
- •6: receipt of blood transfusion or intravenous iron therapy within 1 month before enrollment Psychiatric disorders or cognitive impairment that would interfere with study participation or compliance with study procedures
研究组 & 干预措施
Preconception Group
Townships assigned to this group implement anemia screening and indicated iron treatment before conception.
干预措施: Preconception Anemia Screening and Treatment Strategy (Other)
Early-Pregnancy Group
Townships assigned to this group implement the same anemia screening and indicated iron treatment during early pregnancy.
干预措施: Early-Pregnancy Anemia Screening and Treatment Strategy (Other)
结局指标
主要结局
Proportion of participants with iron deficiency anemia during late pregnancy
时间窗: From 28 weeks' gestation to delivery
Iron deficiency anemia is defined as a hemoglobin concentration of less than 110 g/L and a serum ferritin concentration of less than 20 μg/L, measured in the same blood sample. Participants meeting both criteria at least once during any scheduled assessment from 28 weeks' gestation through delivery will be classified as having the primary outcome.
次要结局
未报告次要终点