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临床试验/CTRI/2021/07/035271
CTRI/2021/07/035271尚未招募2 期

Daily versus intermittent oral iron therapy in pregnant women with iron deficiency anaemia: A single centre, open label, non-randomized control trial.

Government Medical College1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2021年2月8日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
124
试验地点
1
主要终点
response to therapy

研究概览

简要总结

Daily versus alternate day therapy of oral iron in the treatment of iron deficiency anaemia is done to see and comp[are  the efficacy , compliance and side effects  . It may have implications in the treatment of iron deficiency of iron deficiency anaemia in pregnancy

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Pregnant women with haemoglobin concentration less than 11 g/dL and haematocrit less than 33% with singleton pregnancy between 16-28 weeks of gestation, irrespective of parity will be taken.

排除标准

  • •Multiple pregnancy •underweight (BMI < 18.5 kg/m2) or obese(>30kg/m2) •Severe anemia with maternal hemoglobin levels less than 7 g/dL •Hypertensive disorders of pregnancy •Diabetes mellitus (gestational /overt ) not controlled on diet •Anaemia of chronic disease •History of gastrointestinal bleeding •Haemoglobinopathies •Megaloblastic anaemia •HIV, HBsAg, HCV, Covid-19 positive.

结局指标

主要结局

response to therapy

时间窗: response to therapy | Following blood tests will be done as baseline ,3-week ,6 week interval | •Complete blood count | •Total iron study

•Complete blood count

时间窗: response to therapy | Following blood tests will be done as baseline ,3-week ,6 week interval | •Complete blood count | •Total iron study

•Total iron study

时间窗: response to therapy | Following blood tests will be done as baseline ,3-week ,6 week interval | •Complete blood count | •Total iron study

Following blood tests will be done as baseline ,3-week ,6 week interval

时间窗: response to therapy | Following blood tests will be done as baseline ,3-week ,6 week interval | •Complete blood count | •Total iron study

次要结局

  • Side effects,compliance(3 week,6 week)

研究者

申办方类型
Government medical college

研究点 (1)

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