Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Phase
Not applicable
Started
2026-07-10
Last updated
2026-09-17
Condition(s) studied
Iron Deficiency Anemia
Investigational drug(s) / intervention(s)
Preconception Anemia Screening and Treatment StrategyEarly-Pregnancy Anemia Screening and Treatment Strategy
Preconception Anemia Screening and Treatment Strategy: Women 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: Women 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
Study summary
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
Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
Proportion of participants with iron deficiency anemia during late pregnancy — 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.
Trial sites (1)
Facility
City
Region
Status
Yanjin County Maternal and Child Health Hospital
Zhaotong
Yunnan
Recruiting
More Xinhua Hospital, Shanghai Jiao Tong University School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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