Iron Deficiency Anemia in the Second and Third Trimester of Pregnancy: Evaluation of the Contribution of Sucrosomial Iron Supplementation (Sideral® Folico)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 82
- 主要终点
- Anemia correction
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
iron deficiency anemia in pregnancy
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.
干预措施: Sideral Folico (Combination Product)
结局指标
主要结局
Anemia correction
时间窗: 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)
次要结局
- Compliance of treatment(15 days)
