About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Preconception Anemia Screening and Treatment Strategy
Other interventionWomen planning pregnancy within 6 months undergo hemoglobin, hemoglobin electrophoresis, and serum ferritin assessments before conception. Those with hemoglobin levels below 120 g/L and/or serum ferritin levels below 30 μg/L receive oral ferrous succinate (0.2 g twice daily) plus vitamin C, with scheduled hematologic monitoring.
Early-Pregnancy Anemia Screening and Treatment Strategy
Other interventionWomen with a singleton pregnancy at 12 weeks' gestation who have hemoglobin levels below 110 g/L and/or serum ferritin levels below 30 μg/L will receive oral ferrous succinate (0.2 g twice daily) plus vitamin C, with scheduled hematologic monitoring
Treatment groups
Trial outcomes
Primary outcomes
Proportion of participants with iron deficiency anemia during late pregnancy
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.
Sponsors and contacts
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