Clinical Trial

Iron Deficiency Anemia in the Second and Third Trimester of Pregnancy

Study acronym: PESO
Not Yet Recruiting
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Summary
Iron deficiency is the most frequent cause of anemia during pregnancy and of maternal blood transfusion during the post-partum period. Intravenous administration is the fastest route to correct iron deficiency, bypassing the filter of iron intestinal absorption, the only true mechanism of iron balance regulation in the human body. Intravenous iron administration is suggested in patients who are refractory/intolerant to oral iron sulfate. This approach is expected to increase of at least 1 gr/dL the level of hemoglobin in 4 weeks. However, the intravenous route of iron administration has some drawbacks; first it is allowed only as in-hospital procedure and requires a resuscitation service, in accordance with the recommendations of the European Medicine Agency. Moreover, it is very expensive and negatively affects patient's perceived quality of life. A new oral iron formulation, Sucrosomial iron, bypassing the normal route of absorption, appears to be better tolerated and more cost-effective in correcting iron deficiency anemia at doses higher than those usually effective with other oral iron formulations. The hypothesis of the present study is that oral sucrosomial iron can correct iron deficiency anemia during pregnancy comparably to intravenous ferrous sulphate, with less side effects.
Trial Details
NCT Number NCT07163390
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions Anemia, Iron Deficiency, Pregnancy Anemia
Enrollment 82 participants
Start Date 2025-09-15
Primary Completion 2027-07-15 (estimated)
Study Completion 2027-09-15 (estimated)
Updated on ClinicalTrials.gov 2025-09-09