Iron Deficiency Anemia in the Second and Third Trimester of Pregnancy

NCT07163390 | Not Yet Recruiting

• 1 other identifier: 7816
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Anemia, Iron Deficiency; Pregnancy Anemia

Outcome Measures

Primary Outcomes (1)

• Anemia correction

  to evaluate the contribution of the product Sucrosomial iron® 30 mg (Sideral® Folico) to determine a rise of 1g/dl of haemoglobin in 30 days of supplementation. To this end the patients will undergo to the following exams: \- T0: evaluation of blood levels of Hb, Ferritin, sideremia, mean globular volume (MCV), transferrin saturation, Reactive C-Protein (PCR), according to routine clinical practice. Collection of medical and obstetric history and anthropometric parameters. Record of red meat consumption (more or less than twice a week). These evaluations will be made after after 15 days from the beginning of the supplementation, according to routine clinical practice (T1) and after 30 days from the beginning of the supplementation (T2)

  one month

Secondary Outcomes (1)

• Compliance of treatment

  15 days

Study Arms (1)

iron deficiency anemia in pregnancy

EXPERIMENTAL

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.

Combination Product: Sideral Folico

Interventions

Sideral Folico COMBINATION_PRODUCT

Pregnant women will be enrolled from 24 to 32 weeks of gestation whether their hemoglobin levels are comprised between 8.5 and 10.5 g/dl. They start oral supplementation with Sucrosomial iron® 30 mg (Sideral® Folico), 2 sticks for twice a day for 15 days, followed by Sucrosomial iron ® 30 mg (Sideral® Folico), 1 stick for twice a day for the next 15 days

iron deficiency anemia in pregnancy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Giancarlo Paradisi

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giancarlo Paradisi

CONTACT

+39 0630155590; giancarlo.paradisi@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 9, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-08