Preconception vs First-Trimester Screening and Treatment for Iron Deficiency Anemia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Preconception Anemia Screening and Treatment Strategy

    Other intervention

    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

    Other intervention

    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

Treatment groups

960 Participants
are divided into 2 treatment groups
Group A: Preconception GroupExperimental treatment 1 intervention
Group B: Early-Pregnancy GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From 28 weeks' gestation to delivery

Secondary outcomes

Other outcomes

Sponsors and contacts

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