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临床试验/NCT07110935
NCT07110935已完成1 期

Efficacy of Treatment of Postpartum Anaemia With Intravenous Iron Versus Oral Iron

Federal Teaching Hospital Abakaliki1 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2018年9月13日最近更新:
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
290
试验地点
1
主要终点
Mean postpartum haematocrit

研究概览

简要总结

Background:Anaemia is a condition of public health importance.Iron deficiency anaemia is the most common cause of anaemia in pregnancy.Postpartum anaemia poses a significant role for postpartum morbidity and mortality and should be treated.Postpartum iron deficiency anaemia warrants greater attention and higher quality of care.Oral iron treatment has been considered the standard of care.

However,parenteral iron treatment is expected to be advantageous in cases where oral iron therapy is not possible.As a result,there is increased interest in parenteral iron therapy.

Objectives:To determine the effect of treatment of postpartum anaemia with intravenous versus oral iron therapy at Federal Medical Centre,Umuahia.

Materials and Method:This study is a prospective randomized controlled study carried out in department of Obstetric and Gynaecology, Federal Medical Centre,Umuahia,the capital of Abia State,South-east, Nigeria. The study population comprised of postpartum women with mild to moderate anaemia within 48 hours of delivery who were randomized into two groups.One group will be given oral iron therapy and the other intravenous iron dextran.Response and comparative effects of treatment using either route of administration were assessed at 6 weeks postpartum.The biodata,obstetric characteristics and haemoglobin estimation of the respondents were recorded on a structured study proforma.The data obtained from the study was analyzed with the statistical package for the social sciences(SPSS) software.Continuous variables obtained from this study were expressed as mean and standard deviation while categorical variables were summarized using frequency and percentages.Association between categorical variables were done using chi square.P-value less than 0.05 was taken as significant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who have vaginal delivery of singleton baby and are seen within 48hours of childbirth
  • Women with mild and moderate anaemia
  • Women who gave their consent to participate in the study.

排除标准

  • Women with severe anaemia
  • Women with multiple pregnancy
  • Women with genotype HbSS
  • Women with HIV infection
  • Women who delivered by caesarean section
  • Women with co-morbidity like hypertensive disorders, renal pathology
  • Women who decline consent after adequate counseling.
  • Previous and current history of adverse reaction to iron dextran

研究组 & 干预措施

One hundred and forty five women who picked "i" were assigned intravenous iron therapy group

Experimental

干预措施: intravenous iron (Drug)

One hundred and forty five women who picked "o" were assigned oral iron therapy group

Active Comparator

干预措施: oral iron (Drug)

结局指标

主要结局

Mean postpartum haematocrit

时间窗: Six weeks

Mean hematocrit following treatment with iron dextran

时间窗: Six weeks

次要结局

  • Incidence and patterns of postpartum anaemia(Six weeks)

研究者

发起方
Federal Teaching Hospital Abakaliki
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Assumpta Nnenna Nweke

Dr Assumpta Nnenna Nweke

Federal Teaching Hospital Abakaliki

研究点 (1)

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