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Preconception vs First-Trimester Screening and Treatment for Iron Deficiency Anemia: A Cluster Randomized Trial

RecruitingNA

Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Conditions: Iron Deficiency Anemia

Interventions: Preconception Anemia Screening and Treatment Strategy, Early-Pregnancy Anemia Screening and Treatment Strategy

Countries: China

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 overview

Sex: FEMALE

Age: 18 Years to 45 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

\- Women are eligible if they are aged 18-45 years, reside in a participating township, intend to attempt natural conception within the next 6 months, can complete study procedures and provide written informed consent.

Exclusion Criteria:

* 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

Locations (1)

Zhaotong, Yunnan, China