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临床试验/NCT00494416
NCT00494416已完成不适用

A Comparison of Different Approaches for Delivery of Intermittent Preventive Treatment (IPT)to Pregnant Women in Burkina Faso With Regard to Coverage and Compliance

London School of Hygiene and Tropical Medicine2 个研究点 分布在 1 个国家目标入组 11,523 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11,523
试验地点
2
主要终点
compliance

研究概览

简要总结

IPT/SP was adopted in 2005 by The Ministry of Health (MoH) of Burkina Faso to replace chemoprophylaxis with CQ in pregnancy. The new strategy is being implemented but no delivery approach was defined and presumably IPT/SP will only be delivered to pregnant women presenting at ANC visits. It would be of extreme importance to ensure a better coverage and higher compliance to make the new strategy effective. In order to obtain a more efficient IPT/SP programme with a good level of compliance and coverage, several delivery approaches beside ANC should be explored.

The study site will be in Pissy health district covering both peri-urban Ouagadougou city and rural areas. Participants include pregnant women irrespective of gravidity residing in the study area.

The study is a prospective comparative study of 3 different approaches of delivering IPT/SP in the catchment areas of rural health facilities. The approaches will be the following:

  1. Passive health centre based delivery approach (PHC). IPT/SP will be delivered to pregnant women presenting to the health centre for ANC visits.
  2. Joint, with an advanced strategies delivery approach (JAS). In addition to passive delivery at health centres, the pregnant women will be reached during preventive activities the health staff carry out regularly in villages, such as immunization, health promotion, and even ANC visits.
  3. Community based distribution delivery approach (CBD). In addition to passive delivery at health centres, the pregnant women will be reached by traditional birth attendants (TBAs) or representatives of village women's associations (RWAs). Each approach will be implemented in a zone constituted by the catchment area of a number of health centres to achieve the required sample size. The zones will be randomly assigned to a delivery approach. The main outcomes to be measured are: a) the coverage of IPT, b) compliance, c) infection prevalence, d) Hb level, e) difficulties and constraints of each approach, f) the acceptability to population and health staff and g) the performance of each approach to deliver IPT /SP. to be able to identify a significant increase in coverage of 10%, each group should be composed of n = 3841 pregnant women.

Cross sectional surveys will be carried out at the beginning, during and at the end of the study period. The study will be carried out over 24 months from June 2007.

详细描述

Pregnant women are more susceptible to malaria than non-pregnant women, in particular during the first pregnancies. Malaria infection in pregnant women may cause anaemia, illness and abortion or stillbirth. It may also cause low birth weight through placental infection. In Africa the burden of malaria in pregnancy is highest in remote rural areas. IPT with sulphadoxine - pyrimethamine (SP) has been demonstrated to be effective in preventing pregnancy related malaria (anaemia, clinical cases and placenta infection), and to be beneficial to both babies and pregnant women, and increasing ANC attendance. In many Sub - Saharan African countries, IPT / SP is being adopted to replace chloroquine (CQ) as chemoprophylaxis was shown to be no longer efficacious. IPT/SP was adopted in 2005 by The Ministry of Health (MoH) of Burkina Faso to replace chemoprophylaxis with CQ. The new strategy is being implemented but no delivery approach was defined and presumably IPT/SP will only be delivered to pregnant women presenting at ANC visits. Although the expected compliance should be better than for the previous CQ weekly regime, it would be of importance to ensure a better coverage and higher compliance to make the new strategy effective. Therefore, in order to obtain a more efficient IPT / SP programme with a good level of compliance and coverage, several delivery approaches beside use of ANC alone will be explored. It is hypothesized that the IPT strategy using SP will be as inefficient as chemoprophylaxis with CQ if an effective delivery approach is not used.

General Objective: to assess different IPT/SP delivery approaches in rural Burkina Faso with the aim of improving coverage and compliance among pregnant women.

Specific objectives:

  • To implement three approaches of IPT/SP delivery to pregnant women based on health centre distribution, and in addition community based distribution either by health services or by community members;
  • To compare the effects of the approaches on compliance to and coverage of IPT / SP and their feasibility.

Material & Methods

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 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women of all parities
  • Second trimester

排除标准

  • Severely ill pregnant women
  • Pregnant women in first trimester

结局指标

主要结局

compliance

时间窗: 24 month after study start

coverage

时间窗: 24 month after study start

次要结局

未报告次要终点

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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