Iron Deficiency Anemia in the Second and Third Trimester of Pregnancy (PESO)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Anemia, Iron Deficiency; Pregnancy Anemia

Treatments: Combination Product: Sideral Folico

Study type: Interventional

Funder types: Other

Identifiers

NCT07163390

7816

Details and patient eligibility

About

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.

Enrollment: 82 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Patients with preclampsia
• twin pregnancy
• chronic diseases
• drug exposure
• BMI<18 or >30
• malabsorption
• fetal growth restriction
• age < 18 years
• haematologic diseases
• symptomatic anemia (dyspnea, tachycardia)
• inability to sign an informed written consent

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 1 patient group

iron deficiency anemia in pregnancy

Experimental group

Description:

Women with ongoing pregnancy attending at Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome will be prospectively enrolled from 24 to 32 weeks of pregnancy whether their hemoglobin levels are comprised between 8.5 and 10.5 g/dl. Patients will discontinue any other ongoing oral supplementation.

Treatment:

Combination Product: Sideral Folico