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Safety and Efficacy of Iron Prophylaxis With on Iron Homeostasis in Healthy Pregnant Women

RecruitingNAAges 18 Years - 45 YearsFemaleIBSA Farmaceutici Italia Srl
NCT07884617 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The clinical study aims to evaluate the effect of iron supplementation in preventing the onset of Iron Deficiency Anemia during pregnancy. The trial is designed as a double-arm, double-blind clinical study comparing iron supplementation versus placebo in pregnant women. The primary objective is to assess the efficacy of iron supplementation in maintaining adequate levels of hemoglobin throughout gestation, while secondary outcomes include maternal hematological parameters and pregnancy outcomes.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Healthy Caucasian women aged 18-45 years. 2. Single, viable pregnancy. 3. Plasma ferritin levels in the first trimester ≤ 70 ng/mL. 4. Hb levels in the first trimester ≥ 110 g/L. 5. Understanding and signing of the informed consent. Exclusion Criteria: 1. Anemia (Hb levels \< 110 g/L), adequate iron repletion (serum ferritin levels \> 70 ng/mL). 2. Multiple pregnancy (twins). 3. Known comorbidities or chronic therapy administered to the pregnant. 4. Maternal pathologies interfering with iron absorption (e.g. celiac disease, inflammatory bowel disease - IBD). 5. Abnormal Hb electrophoresis result. 6. Fetal anomalies detected during pregnancy. 7. Specific diets (e.g. gluten-free, vegan, or vegetarian). 8. Any nutritional supplement except for folic acid, vitamin D and/or isolated omega 3, and, in any case, based on the Investigator's case by-case evaluation. 9. Obesity (pre-pregnancy Body Mass index, BMI ≥ 30kg/m2). 10. Any clinical condition that is deemed not compatible with the study based on the Investigator's evaluation.
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What it tests

  • Iron plus folic acid
  • Folic acid
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Where

1 site
SC Ostetricia - Clinica Mangiagalli, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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