ISRCTN63484804已完成3 期
Intravenous versus oral iron for iron deficiency anaemia in pregnant Nigerian women (IVON): an open label, randomized controlled trial
niversity of Lagos0 个研究点目标入组 1,056 人开始时间: 2020年12月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,056
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36076211/ (added 09/09/2022) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38347614/ Qualitative study (added 13/02/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Pregnant women aged 15 to 49 years old between 20- and 32-weeks’ gestational age
- •2. Baseline (enrolment) laboratory-confirmed moderate or severe anemia (Hb <10 g/dl)
排除标准
- •Current exclusion criteria as of 27/06/2022:
- •1. Medically confirmed significant bleeding, major surgery or received blood transfusion within the last 3 months.
- •2. Severe symptomatic anemia needing urgent correction with blood transfusion.
- •3. Anemia of other cause besides IDA e.g., Sickle cell anemia.
- •4. Clinically confirmed malabsorption syndrome.
- •5. Hypersensitivity to any form of iron treatment.
- •6. History of any immune related illness e.g., SLE, Rheumatoid arthritis.
- •7. Preexisting maternal depression or other psychiatric illness.
- •8. Severe allergic reactions such as severe asthma.
- •9. History of severe drug allergy.
- •Previous exclusion criteria:
- •1. Medically confirmed significant bleeding, major surgery or received a blood transfusion within the last 3 months
- •2. Symptomatic anaemia with dyspnea or fatigue and a need for urgent correction
- •3. Concurrent anaemia of another cause besides IDA
- •4. Clinically-confirmed malabsorption syndrome or hypersensitivity to any form of iron treatment
- •5. Preexisting maternal depression or other psychiatric illness
研究者
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