Lactoferrin Versus Total Dose Infusion (TDI) For Treating Iron Deficiency Anemia in Pregnancy: Role of Nursing
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- the change in Hb concentration
研究概览
简要总结
This study consisted of 60 cases. All the cases of pregnant women are 4 months to 8 months of pregnancy. The cases divided into 30 pregnant women's were given iron supplementation without health education and another 30 were given iron supplementation and health education for comparison between them. Comparative between hemoglobin levels before and after medication. Treatment of iron deficiency anemia with iron supplementation received for one month.
详细描述
The investigator will divide the participants into two groups e.g. group (A) and group (B) according to Hemoglobin level and receiving of oral supplementation for IDA accompanied with health education in case of group (A) and without health education in case of group (B). Then the investigator asked patient to sign the document of her investigations result to receive iron supplementation.
- After that, the investigator observes hemoglobin's Level, when it less than >11g/dl, the patient will be the group (A) who will receive oral iron supplementation and health education.
- Group (B) who will receive Total Dose Infusion (TDI) without health education.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant Women aged >18 years
- •Hemoglobin<10g/dl
- •Gestational age between 14-28 weeks
- •Singleton pregnancy
- •Willingness to participate and signing the informed consent form
排除标准
- •Anemia predominantly caused by factors other than IDA (e.g. anemia with untreated B12 or foliate deficiency, hemolytic anemia),
- •Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and haemosidrosis).
- •Decompensated liver cirrhosis and active hepatitis (ALAT>3 times upper limit of normal).
- •Active acute or chronic infections (assessed by clinical judgment supplied with white Blood Cells (WBC) and C - reactive protein (CRP).
- •Rheumatoid arthritis with symptoms or signs of active inflammation.
- •Multiple allergies.
- •Known hypersensitivity to parental iron or any recipients in the investigational drug products.
- •Erythropoietin treatment within 8 weeks prior to the screening visit.
- •Other iron treatment within 8 weeks prior to the screening visit.
- •Planned elective surgery during the study.
- •Participation in any other clinical within 3 months prior to the screening.
- •Any other medical condition e.g. malignancy, uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus.
研究组 & 干预措施
Oral Lactoferrin
Group A is 120 mg of Oral lactoferrin for 4 weeks Intervention: The participants 66 will receive oral Lactoferrin 120mg for 4 weeks
干预措施: Oral lactoferrin (Combination Product)
Total dose infusion (TDI) iron dextran
Group B is a parenteral total dose infusion (TDI) of LMW iron dextran 20mg/kg body weight for 4 weeks Intervention: The participants 33 will receive parental iron 20mg/kg body weight for 4 weeks
干预措施: TDI of LMW iron dextran (Combination Product)
结局指标
主要结局
the change in Hb concentration
时间窗: 4- 8 weeks
measure the change in Hb concentration from baseline to week 4 after oral Lactoferrin treatment and relieve of symptoms of anemia
次要结局
- measure the change in serum iron, serum ferritin(4-8 weeks)
研究者
Howieda Fouly
PhD of Obstetric & Gynecologic Nursing
Woman's Health University Hospital, Egypt