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临床试验/NCT00488579
NCT00488579已完成4 期

Routine Iron Prophylaxis During Pregnancy - Effects on Maternal and Child Health in Maputo City and Province (Mozambique)

National Istitute For Health and Welfare, Finland1 个研究点 分布在 1 个国家目标入组 4,326 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
4,326
试验地点
1
主要终点
Preterm delivery

研究概览

简要总结

Comparison of two policies of iron administration during pregnancy in regard to health and program feasibility in an area with endemic malaria and high prevalence of HIV infection. The policies are: 1) routine iron prophylaxis, 2) screening and therapy with iron.

详细描述

Aim of the study:

Comparison of two policies of iron administration during pregnancy in regard to health of the mother and infant and program feasibility. The two groups compared are:

  1. Routine iron prophylaxis
  2. Screening of anaemia and therapy with iron

Hypothesis: group 2 will have better health outcomes.

Study groups:

研究设计

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

入排标准

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

入选标准

  • Pregnant women at their first prenatal visit

排除标准

  • Women under 18 years, high obstetric risk pregnancies

研究组 & 干预措施

routine iron prophylaxis

Active Comparator

giving 60 mg ferrous sulphate daily (+folic acid)

干预措施: Two policies of iron prophylaxis (Drug)

screening and therapy

Active Comparator

doing Hb measurement on each visit, Hb>9g/dl giving only folic acid, Hb<9g/dl giving 60-120 mg of ferrous sulphate daily (+folic acid)

干预措施: Two policies of iron prophylaxis (Drug)

结局指标

主要结局

Preterm delivery

时间窗: Until birth

Birth \<37 gestational weeks

Low birth weight

时间窗: At birth

weight \<2500g

次要结局

  • perinatal mortality, complications during pregnancy and birth(pregnancy and neonatal period)

研究者

发起方
National Istitute For Health and Welfare, Finland
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Elina Hemminki

MD, Research Professor, THL

National Istitute For Health and Welfare, Finland

研究点 (1)

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