Anemia, Iron Deficiency, Pregnancy Anemia
Conditions
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.
Interventions
COMBINATION_PRODUCTSideral 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
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anemia correction | one month | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance of treatment | 15 days | to evaluate the tolerability of the product Sucrosomial iron® 30 mg (Sideral® Folico) the Visual Analogue Scale (VAS) or the 0-10 numeric scale for gastrointestinal pain will be used. Other assessments include measuring the rate of nausea, constipation or diarrhea, and dark or black stools. All evaluations will be made at T0, T1 and T2. |
Contacts
Primary ContactGiancarlo Paradisi
Outcome results
None listed