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临床试验/ISRCTN51426226
ISRCTN51426226进行中(未招募)3 期

Intravenous ferric carboxymaltose versus oral ferrous sulphate for the treatment of moderate to severe postpartum anaemia in Nigerian women

niversity of Lagos0 个研究点目标入组 1,400 人开始时间: 2022年10月3日最近更新:
适应症

试验速览

阶段
3 期
状态
进行中(未招募)
发起方
入组人数
1,400

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

性别
Female

入选标准

  • 1. Women aged between 15 and 49 years
  • 2. Between 6 and 48 hours after delivery
  • 3. Baseline (enrollment) moderate or severe anemia (Hb = 9.9g/dl), confirmed by Hemocue haemoglobinometer
  • 4. Able and willing to give written informed consent

排除标准

  • 1. Having received a blood transfusion, for any indication, within the last 3 months
  • 2. Symptomatic anemia and a need for urgent correction
  • 3. Known haemoglobinopathy such as sickle cell disease, HbCC disease
  • 4. Clinically confirmed malabsorption syndrome
  • 5. Known hypersensitivity or contraindication to any form of iron treatment, study drug or any of its excipients
  • 6. Self-reported pre-existing maternal depression or other psychiatric illness and as evidenced by a YES response to any past history of psychiatry ward hospitalization, psychiatry medications, behavioral changes, or past consultation with psychiatry services
  • 7. Severe allergic conditions such as severe asthma, eczema or other atopic condition
  • 8. Known autoimmune conditions e.g., systemic lupus erythematosus, rheumatoid arthritis or known severe drug allergies.
  • 9. Planning to move or reside outside the research area

研究者

发起方
niversity of Lagos

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