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临床试验/NCT00680732
NCT00680732已完成4 期

Prevention of Intrauterine Growth Retardation in Hounde District, Burkina Faso: the Malaria Component

Institute of Tropical Medicine, Belgium1 个研究点 分布在 1 个国家目标入组 1,370 人开始时间: 2003年6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
1,370
试验地点
1
主要终点
Efficacy of standard antimalarial treatment in preventing clinical malaria in pregnant women under weekly chemoprophylaxis or intermittent treatment.

研究概览

简要总结

Our objective was to investigate the importance of malaria infection/disease during pregnancy and more particularly during the first trimester; we also looked at the maternal-foetal interactions and their influence on the subsequent child's response to malaria infections during the first year of life. This study was carried out !in the same population recruited for the IUGR study (NCT00642408).

详细描述

A research project aiming at investigating the impact of multivitamin-mineral supplementation (MMS) during pregnancy on intra-uterin growth retardation was carried out in the Hounde district, an area not far from the Centre Muraz located in Bobo Dioulasso, and where malaria is endemic. Malaria during pregnancy increases the risk of low birth weight, infant mortality and morbidity during the first year of life by inducing growth retardation, prematurity and infant anaemia.

The administration of an antimalarial drug during pregnancy has a beneficial effect on the mother and child's health by preventing malaria infection and its consequences. However, most studies have been carried out during the second or third trimester of pregnancy: the effect of malaria infection during the first trimester on the mother's and child's health is unknown. It has been reported that even one single infection may have a significant impact on the outcome of pregnancy: if it is true, then early chemoprophylaxis may have an additional advantage.

An alternative approach is the administration of intermittent presumptive treatment, which may achieve equal efficacy to continuos chemoprophylaxis; however, no studies compared effective weekly malaria chemoprophylaxis with effective intermittent presumptive treatment. Moreover, the incidence of malaria clinical episodes during SP intermittent preventive treatment has never been investigated.

Therefore, this open label, factorial study was carried out in the same women recruited for the IUGR nutritional study (NCT00642408). Women receiving multiple micronutrients supplements (MMS) or dietary supplements (IFA) were further randomised in 2 groups: CQ weekly chemoprophylaxis or SP intermittent preventive treatment. The administration of treatment was directly observed.

研究设计

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

入排标准

年龄范围
15 Years 至 44 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 15 to 44 years
  • living in the study area

排除标准

  • planning to move outside the district within two years
  • regularly using a contraceptive methods
  • already pregnant at the start of the trial

研究组 & 干预措施

A1

Experimental

Multiple micronutrients supplements (MMS) and weekly chloroquine (CQ)

干预措施: Multiple micronutrients supplements (MMS) (Dietary Supplement)

A1

Experimental

Multiple micronutrients supplements (MMS) and weekly chloroquine (CQ)

干预措施: Chloroquine (CQ) (Drug)

A2

Experimental

Multiple micronutrients supplements (MMS) and intermittent suplphadoxyne-pyrimethamine (SP)

干预措施: Multiple micronutrients supplements (MMS) (Dietary Supplement)

A2

Experimental

Multiple micronutrients supplements (MMS) and intermittent suplphadoxyne-pyrimethamine (SP)

干预措施: Sulphadoxyne-pyrimethamine (SP) (Drug)

B1

Experimental

Iron and folic acid (IFA) and weekly chloroquine (CQ)

干预措施: Iron and folic acid (IFA) (Dietary Supplement)

B1

Experimental

Iron and folic acid (IFA) and weekly chloroquine (CQ)

干预措施: Chloroquine (CQ) (Drug)

B2

Experimental

Iron and folic acid (IFA) and intermittent sulphadoxyne-pyrimethamine (SP)

干预措施: Iron and folic acid (IFA) (Dietary Supplement)

B2

Experimental

Iron and folic acid (IFA) and intermittent sulphadoxyne-pyrimethamine (SP)

干预措施: Sulphadoxyne-pyrimethamine (SP) (Drug)

结局指标

主要结局

Efficacy of standard antimalarial treatment in preventing clinical malaria in pregnant women under weekly chemoprophylaxis or intermittent treatment.

时间窗: Up to delivery

次要结局

  • To determine if the occurrence of malaria during pregnancy influences the incidence of clinical malaria in infants during their first year of life.(Up to one year after delivery)
  • To determine the burden of clinical malaria during pregnancy and its consequences on maternal anaemia, new birth weight and foetal anaemia.(Up to delivery)
  • Effect of standard antimalarial treatment on the selection of resistant parasites in pregnant women under weekly chemoprophylaxis or intermittent treatment.(Up to one year after delivery)

研究者

发起方
Institute of Tropical Medicine, Belgium
申办方类型
Other

研究点 (1)

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