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临床试验/NCT01703884
NCT01703884已完成4 期

Improved Quality of ANC and Diagnostic Services for Malaria in Pregnancy

Centre Muraz1 个研究点 分布在 1 个国家目标入组 5,254 人开始时间: 2012年8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
Centre Muraz
入组人数
5,254
试验地点
1
主要终点
Placental malaria at delivery

研究概览

简要总结

The program's overall objective is to assess the impact of a package of interventions aimed at reducing malaria-related mortality and morbidity in pregnant women and newborns by ensuring access to a package of interventions designed to optimise the detection and treatment of malaria during pregnancy as well as improving the early detection and treatment of malaria during the third trimester.

详细描述

This is a cluster-randomised study in which the health facility is the unit of randomisation. 16 health facilities will be randomised to intervention and control. At the community level women will be encouraged to access ANC early in the pregnancy, attend follow-up antenatal visits throughout the pregnancy and deliver at the facility. The current recommended standard of care will be provided to all women attending antenatal and obstetric care. In the intervention area, obstetric, medical, drug-exposure histories will be collected at ANC visits. In addition, in the last trimester of the pregnancy (> 28 weeks of pregnancy), women will be systematically evaluated with selected diagnostic test for whether they have malaria parasites and treated effectively. Skilled birth attendants at the facility will be trained in emergency obstetric and neonatal care and the assessment of neonates for danger signs, low birth weight and external/observable birth defects. In the control area, women will be provided with standard practice of care. In both areas, women will be diagnosed and treated at delivery if they are positive.

研究设计

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

入排标准

年龄范围
16 Years 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Located in the geographical location of Dafra & Do district
  • Have a minimum attendance of 200 pregnant women per year

排除标准

  • other public health facilities, private clinics and Dafra District Hospital will be excluded from the study.

研究组 & 干预措施

ASAQ

Experimental

In the intervention area, obstetric, medical, drug-exposure histories will be collected at ANC visits. In addition, in the last trimester of the pregnancy women will be systematically evaluated with RDT for whether they have malaria parasites and treated effectively.

干预措施: ASAQ (Drug)

结局指标

主要结局

Placental malaria at delivery

时间窗: 9 months

The main outcome variable of interest will be the proportion of women in each group with placental malaria at delivery (defined as placental biopsies positive for P. falciparum )

次要结局

  • The proportion of women with peripheral positive malaria infection at delivery(9 months)

研究者

发起方
Centre Muraz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tinto Halidou

PharmD, Msc, PhD

Centre Muraz

研究点 (1)

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