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临床试验/NCT03725150
NCT03725150已完成不适用

Iron Deficiency Anaemia in Pregnancy: an Observational Study of Tolerability, Compliance With Oral Iron Therapy and Effects on Haematological/Biochemical Markers

The Royal Wolverhampton Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
An increase in haemoglobin of at least 10g/L

研究概览

简要总结

The burden of anaemia remains unacceptably high during pregnancy. Over a third of women are anaemic by their third trimester of pregnancy. The most common cause is iron deficiency. One key factor is rising iron requirements throughout pregnancy. There are risks associated with anaemia for the mother and infant. Anaemia in the first and second trimester has been significantly correlated with low birth weight and pre-term birth, and is associated with impaired neurological development of the baby. It also increases the risk of intrauterine fetal death, and the likelihood of the mother requiring blood transfusions during or after delivery.This study is a prospective cohort study, which aims to better define the natural history and understand how to use oral iron therapy for iron deficiency anaemia in pregnant women. This includes documenting the impact of treatment on anaemia symptoms, side effects, and the level of success of iron therapy using several haematological tests. Pregnant women will be invited to participate in this study and treated using a treatment schedule as described in national guidelines. Additional blood samples will be taken for subsequent detailed analysis of pathways of iron metabolism to better predict the response to oral iron therapy during pregnancy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women (any stage during pregnancy up to 36 weeks) and women in the puerperium (within 6 weeks postdelivery) with anaemia as defined by World Health Organization (WHO) criteria and described in British Society Haematology (BSH)/ British Committee for standards in Haematology (BCSH) guidelines.
  • First trimester < 110g/l
  • Second and third trimester < 105g/l
  • Puerperium < 100g/l
  • Age: 18-45 years
  • Agreement to participate in the study with consenting

排除标准

  • Anaemic women presenting at or after 36 weeks as there may be insufficient time to delivery to assess responses to oral iron)
  • Anaemic women affected by a (major) haemoglobinopathy e.g. B thalassaemia major sickle cell disease
  • Women with overt clinical signs of sepsis
  • Allergies to iron
  • Hyperemesis Gravidarum / persistent vomiting
  • Women with inflammatory conditions such as Crohns, ulcerative colitis, Systemic lupus erythematosus, Rheumatoid arthritis.
  • Women with chronic renal failure

结局指标

主要结局

An increase in haemoglobin of at least 10g/L

时间窗: 2 to 4 weeks after the onset of iron therapy.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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