Iron Deficiency Anemia in the Second and Third Trimester of Pregnancy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

Qualifiers

Pregnant women from 24 to 32 weeks of pregnancy

Age ≥18 ys old

Hemoglobin between 8.5 and 10.5 g/dl

Ability to sign an informed written consent

Disqualifiers

Patients with preclampsia

twin pregnancy

chronic diseases

drug exposure

Trial design

Treatments tested in this trial

  • Sideral Folico

Treatment groups

82 Participants
are divided into 1 treatment group

Locations

This trial has no locations