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临床试验/CTRI/2021/08/036037
CTRI/2021/08/036037招募中未知

Implementation research to explore operational feasibility, acceptability and cost-effectiveness of using IVFerric Carboxy Maltose (FCM) in Management of Iron Deficiency Anemia (IDA) among pregnant women through sub district health systemin Maharashtra

Department of health research0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
招募中
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • Diagnosed with iron deficiency anemia with hemoglobin levels between 5- 9.9gm/dl between 22-32 weeks of gestational age with following criteria
  • Severe anemia with hemoglobin <7 gms anytime between 22-32 weeks
  • Moderate anemia with hemoglobin between 7-9.9 gms during 22-28 weeks not responding to oral iron given for 6 weeks
  • Moderate anemia in last trimester irrespective of previous iron intake.
  • Willing to sign an informed consent, deliver at the same site and willing for follow up

排除标准

  • ââ?¬Â¢Pregnant women with hemoglobin levels below 5gm/dl and above 9.9 gm/dl in the first or second trimester of pregnancy.
  • ââ?¬Â¢Pregnant women diagnosed with anemia other than iron deficiency anemia based on peripheral smear examination and red cell indices, picture suggestive of pancytopenia,
  • ââ?¬Â¢Any known cases of hemoglobinopathies or with Pregnancy Induced Hypertension
  • ââ?¬Â¢ History of iron overload disorder (Thalassemia, hemochromatosis, hemosiderosis]
  • ââ?¬Â¢Pregnant women with known cardiac, renal, hepatic disease
  • ââ?¬Â¢Pregnant women having associated medical disorders like hypertension, asthma, tuberculosis, heart disease rheumatic or congenital heart disease), heart failure or cardiac decompensation,
  • ââ?¬Â¢history of intravenous iron therapy in the past 6 months or history of repeated blood transfusions
  • ââ?¬Â¢Pregnant women with known OR history of hypersensitivity to ferric carboxy-maltose or iron sucrose
  • ââ?¬Â¢Pregnant women in labor
  • ââ?¬Â¢Blood loss due to hemodynamic instability
  • ââ?¬Â¢History of malignancy, GI bleed, surgery
  • ââ?¬Â¢suspected acute infections (such as upper respiratory tract infections, urinary tract infections, or fever at the time of visit), h/o of rashes and fever during pregnancy to rule rubella)

研究者

发起方
Department of health research

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