Iron Deficiency Anemia in the Second and Third Trimester of Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sideral Folico.
- Who it may be relevant to
- Registry conditions: Anemia, Iron Deficiency, Pregnancy Anemia. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Iron Deficiency Anemia in the Second and Third Trimester of Pregnancy: Evaluation of the Contribution of Sucrosomial Iron Supplementation (Sideral® Folico)
Overview
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.
Interventions
- Combination product Sideral Folico
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
Primary outcome measures
- Anemia correction [Time frame: one month]
Secondary outcome measures (1)
- Compliance of treatment [Time frame: 15 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07163390 · 7816