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临床试验/NCT04101461
NCT04101461已完成不适用

The Effectiveness of Single Versus Double Daily Dose of Oral Iron on the Prevention of Iron Deficiency Anemia in Obese Pregnant Women

Assiut University1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2019年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
230
试验地点
1
主要终点
The number of anemic women at time of delivery

研究概览

简要总结

Anemia is known as a condition in which the hemoglobin level is lower than normal. Anemia is one of the most common complications during pregnancy. Anemia in pregnancy is defined as a hemoglobin level < 110 g/L . Anemia is an important risk factor in pregnancy which leads to both maternal and fetal morbidity and mortality.

The pregnant woman needs more iron during pregnancy, so iron deficiency anemia is very common during pregnancy. In Egypt; iron deficiency anemia affects about one in every two pregnant women, especially in rural areas. Pregnant women require about 27 mg/day elemental iron to cover their increased need. The pregnant women should start taking a daily supplement of 30mg of elemental iron as a preventive measure against iron deficiency anemia especially in poor countries.

Obesity is defined as having an excessive amount of body fat. The body mass index, a measurement based on height and weight, determines the obese if the figure more than 30 kg/m2. There is an increased rate of overweight and obesity among pregnant women. According to the World Health Organization, 46% of adult females in Egypt are obese.

Many researches in the literature revealed a strong relationship between high BMI in pregnancy and iron deficiency anemia. Hepcidin is an iron regulating hormone in the body. Increases in iron levels in the plasma stimulate the production of hepcidin, which blocks iron absorption from the diet, so; hepcidin production is suppressed in the case of iron deficiency.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Pregnant woman in a singleton pregnancy (12-14 weeks).
  • BMI (30- 40 kg/m2).
  • Normal hemoglobin level (>11 g/dL).
  • Normal hematocrit (Hct 31-41%).
  • Normal ferritin level (6-130 ng/mL).
  • Women willingness to participate in the study.
  • Women living in the nearby area to make follow-up visits possible.

排除标准

  • Multiple gestations.
  • Women received a recent blood transfusion.
  • Women with threatened miscarriage.
  • Women are known to have pathological blood loss.
  • Intolerant to oral iron form.
  • History of the hematologic disorder.
  • Women used iron in the past 3 months.
  • Women with chronic diseases (hypertension, diabetes, renal diseases, thyroid disease......).

研究组 & 干预措施

Group I: 27 mg elemental iron

Active Comparator

will receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks

干预措施: Iron (Drug)

Group I: 27 mg elemental iron

Active Comparator

will receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks

干预措施: Complete blood count (Diagnostic Test)

Group I: 27 mg elemental iron

Active Comparator

will receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks

干预措施: Serum ferritin (Diagnostic Test)

Group I: 27 mg elemental iron

Active Comparator

will receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks

干预措施: Serum hepcidin (Diagnostic Test)

Group I: 27 mg elemental iron

Active Comparator

will receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks

干预措施: Serum Iron (Diagnostic Test)

Group I: 27 mg elemental iron

Active Comparator

will receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks

干预措施: Serum total iron binding capacity (Diagnostic Test)

Group II: 54 mg elemental iron

Active Comparator

will receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks

干预措施: Iron (Drug)

Group II: 54 mg elemental iron

Active Comparator

will receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks

干预措施: Complete blood count (Diagnostic Test)

Group II: 54 mg elemental iron

Active Comparator

will receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks

干预措施: Serum ferritin (Diagnostic Test)

Group II: 54 mg elemental iron

Active Comparator

will receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks

干预措施: Serum hepcidin (Diagnostic Test)

Group II: 54 mg elemental iron

Active Comparator

will receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks

干预措施: Serum Iron (Diagnostic Test)

Group II: 54 mg elemental iron

Active Comparator

will receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks

干预措施: Serum total iron binding capacity (Diagnostic Test)

结局指标

主要结局

The number of anemic women at time of delivery

时间窗: 6 months

次要结局

  • The incidence of patients' reported side effect(6 months)
  • The difference in serum ferritin(6 months)
  • The difference in serum hepcidin(6 months)
  • The mean level of maternal Hemoglobin at 37-38 weeks .(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Khairy Ali

Lecturer

Assiut University

研究点 (1)

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