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临床试验/NCT00120809
NCT00120809已完成3 期

A Randomised, Placebo Controlled Trial of Intermittent Preventative Treatment With Sulfadoxine-pyrimethamine in Gambian Multigravidae.

London School of Hygiene and Tropical Medicine2 个研究点 分布在 2 个国家目标入组 3,000 人开始时间: 2002年7月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
3,000
试验地点
2
主要终点
Hemoglobin concentration at delivery.

研究概览

简要总结

Malaria is particularly harmful during pregnancy causing anemia in the mother and low birth weight which, in turn, increases infant mortality. Thus, the World Health Organization (WHO) now recommends that all pregnant women who live in malaria endemic areas of Africa should receive sulfadoxine-pyrimethamine (SP) at monthly intervals during the second and third trimesters of pregnancy. Malaria is especially severe during first pregnancies and the value of intermittent preventative treatment with SP during first pregnancies has been clearly shown. However, it is less certain whether multigravidae, who are at less risk, also benefit from intermittent preventative treatment with SP. To investigate this, a trial has been conducted in Gambian multigravidae who were given intermittent preventative treatment with SP or placebo during the second and third trimesters. The prevalence of anemia six weeks after delivery, low birth weight and poor outcome of pregnancy in women in each group were studied.

详细描述

Objective

The objective of this study was to determine whether intermittent preventative treatment (IPTp) with sulfadoxine-pyrimethamine (SP) reduced the prevalence of anemia and low birth weight in Gambian multigravidae.

Study area

The study was carried out in 14 mother and child health (MCH) clinics situated on the north and south banks of the River Gambia near to the town of Farafenni in the centre of the country. In this area, malaria is highly seasonal with an entomological inoculation rate of 10 -50 infectious bites per year.

Study population

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double

入排标准

性别
Female
接受健康志愿者

入选标准

  • Multigravid pregnancy.
  • Residence in study area.
  • Informed consent.

排除标准

  • Allergy to sulfonamides.
  • Chronic illness.

结局指标

主要结局

Hemoglobin concentration at delivery.

Birthweight.

次要结局

  • Hemoglobin concentration six weeks after delivery.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brian Greenwood

Professor

London School of Hygiene and Tropical Medicine

研究点 (2)

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