Preconception versus early-pregnancy iron screening and treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This cluster randomized trial compares two approaches to preventing iron deficiency anemia in pregnancy: screening and treating before conception versus starting screening and treatment in early pregnancy. Participants are women aged 18-45 who plan natural conception within six months and reside in a participating township. Outcomes include late-pregnancy iron status and maternal and infant health measures, with a focus on feasibility within the community setting. The study excludes women with non-iron related anemia, significant organ dysfunction, active infections, or multiple pregnancy, and is conducted at a hospital-affiliated site in Yunnan, China.

Why it matters

Who can join: the full rules

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

Where it's running

• Yanjin County Maternal and Child Health Hospital
  Zhaotong, Yunnan, China Recruiting

Study contacts

• Study coordinator: Peipei Hu
• Email: hupphpp@163.com
• Phone: +86-21-25076143

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.