Iron Deficiency Anemia
Conditions
Keywords
Anemia Intervention Timing, Preconception, First Trimester, Iron Deficiency Anemia, Randomized Controlled Trial
Brief 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.
Interventions
OTHERPreconception 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.
OTHEREarly-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
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The trial is open label for participants, care providers, and investigators. Outcome assessors will be blinded to cluster allocation.
Intervention model description
Parallel, two-arm cluster randomized trial. Townships are randomized in a 1:1 ratio to preconception or early-pregnancy anemia screening and treatment strategies.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
CONTACTPeipei Hu
Outcome results
None listed