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Safety and Efficacy of Iron Prophylaxis With on Iron Homeostasis in Healthy Pregnant Women
Sponsor: IBSA Farmaceutici Italia Srl
Summary
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.
Official title: Randomized Double-blind Placebo-controlled Clinical Study to Evaluate the Effects and Safety of Iron Prophylaxis With Ferro IBSA on Iron Homeostasis in Healthy Pregnant Women.
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
162
Start Date
2026-05-18
Completion Date
2028-06
Last Updated
2026-10-20
Healthy Volunteers
No
Interventions
Iron plus folic acid
Ferro IBSA (ferric pyrophosphate 300mg + folic acid 400 mcg), one orodispensable film (ODF) once a day orally.
Folic acid
Folic acid 400 mcg, one orodispensable film (ODF) once a day orally.
Locations (1)
SC Ostetricia - Clinica Mangiagalli, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy