Comparison Between Iron Supplementation Using Total Dose Infusion and Oral Routes for Treatment of Iron Deficiency Anemia in Pregnancy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- The proportion of patients who have been successfully treated
研究概览
简要总结
Evaluate the effect of iron supplementation using oral routes in comparison with total dose infusion of low molecular weight iron dextran in iron deficiency anemia during pregnancy.
详细描述
Patients will be allocated to two groups of 106 each and to insure that everyone has the chance of participation, randomization will be guided by table of random numbers All women recruited in the study will be given 100 mg mebendazole tablets twice daily for 3 days for de-worming and 500 micro gram folic acid daily till the end of the study The required dose will be individually adapted according to the total iron deficit which is dependent on the patient's body weight and hemoglobin status Total iron dose (mg) = weight (kg) X hemoglobin deficit {target hemoglobin (g/l)- Actual hemoglobin (g/l)} X 0.24 + 500 mg The total iron dose needed will be calculated by formula rounded to nearest multiple of 100 Group I includes pregnant women taking 60 mg elemental iron twice per day (120 mg/day) using iron tablets (Theragran Hematinic)® Smith-Kline Beecham, Egypt an affiliated co. to Glaxo Smith-Kline, according to the WHO guidelines for IDA control Group II includes pregnant women taking elemental iron in the form of low molecular weight dextran complex intravenously as a total dose infusion (T.D.I) using iron dextran ampules (Cosmofer)R Pharmacosmos Denmark (Inspire Pharma Egypt) Inclusion criteria
- Maternal age 20-35 years old.
- Singleton pregnancy between 16 - 24 weeks
- Iron deficiency anemia with average hemoglobin ranging from 7-9 g/dL at the onset of the study
Exclusion criteris
- Extremes of reproductive age (less than 20 years old or more than 35 years old).
- Patients with multiple pregnancies.
- Anemia not linked to iron deficiency.
- Allergy to iron derivatives.
- Any medical disorder like diabetes or tuberculosis (TB), viral hepatitis cirrhosis, cardiovascular disease, renal disease, autoimmune disease, suspected acute infection, cancer.
- Those who had received parenteral iron treatment earlier within 3 months before the start of the study.
- Any obstetric complicating factors like pregnancy induced hypertension (PIH).
- Patients with history of chronic blood loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Maternal age 20-35 years old.
- •Singleton pregnancy between 16 - 24 weeks.
- •Iron deficiency anemia with average hemoglobin ranging from 7-9 g % at the onset of the study.
排除标准
- •Extremes of reproductive age (less than 20 years old or more than 35 years old).
- •Patients with multiple pregnancies.
- •Anemia not linked to iron deficiency.
- •Allergy to iron derivatives.
- •Any medical disorder like diabetes or tuberculosis (TB), viral hepatitis cirrhosis, cardiovascular disease, renal disease, autoimmune disease, suspected acute infection, cancer.
- •Those who had received parenteral iron treatment earlier within 3 months before the start of the study.
- •Any obstetric complicating factors like pregnancy induced hypertension.
- •Patients with history of chronic blood loss.
研究组 & 干预措施
Theragran Hematinic, oral iron, 120 mg elemental iron/
pregnant women taking 60 mg elemental iron twice per day (120 mg/day) using iron tablets (Theragran Hematinic)® SmithKline Beecham, Egypt an affiliated co. to GlaxoSmithKline. Adherence to the treatment will be monitored by asking the women to bring back the empty packs and mark the consumption of tablets on calendar.
干预措施: Theragran Hematinic (Drug)
low molecular weight iron dextran, total dose infusion
Pregnant women taking elemental iron in the form of low molecular weight dextran complex intravenously as a total dose infusion (T.D.I) using iron dextran ampules (Cosmofer)R pharmacosmos Denmark (Inspire Pharma Egypt). Patients selected for parental iron will be admitted as day cases in the hospital in a single visit. The required dose has to be individually adapted according to the total iron deficit which is dependent on the patient's body weight and hemoglobin status. Total iron dose (mg) = weight (kg) X Hemoglobin deficit {target Hemoglobin (g/l)- Actual Hemoglobin (g/l)} X 0.24 + 500 mg.
干预措施: low molecular weight iron dextran (Drug)
结局指标
主要结局
The proportion of patients who have been successfully treated
时间窗: up to 8 weeks from comleting treatment
The proportion of patients who have been successfully treated as evidenced by a hemoglobin concentration of \> 10.5 g% after 8 weeks from completing treatment (oral or total iron dose infusion therapy).
次要结局
- Number of participants with adverse effects(up to 8 weeks after completing treatment)
研究者
Mohamed S Sweed, MD
Lecturer of Obstetrics and Gynecology
Ain Shams University