Prevention of P. Vivax Malaria During Pregnancy: Effects on Mother and Child Health in Santa Cruz, Bolivia. Open, Multicentric, Randomized Clinical Trial, Comparing Prophylaxis Once a Week to Malaria Attack Treatment, Both by Chloroquine.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Incidence of women presenting a malaria attack during pregnancy
研究概览
简要总结
The purpose of this study is to determine which, between weekly prophylaxis or malaria attack treatment, both by chloroquine, is the most appropriate way to protect women and foetus from P. vivax malaria infection during pregnancy.
详细描述
It has been demonstrated that malaria is responsible for anaemia during pregnancy and reduces birth weight among newborns. In Bolivia, malaria is mostly caused by P. vivax. Maternal and foetal consequences of P. vivax infections have been poorly investigated until now, over all in South America. In fact, recommendations for the protection of pregnant women from malaria in Bolivia have not been clearly established. Prophylaxis by chloroquine is still recommended in other continents than Africa, mainly because chloroquine resistances are still uncommon in P. vivax species. The alternative way to protect women during pregnancy is to treat malaria attacks during antenatal visits. For this purpose, we will realize a study in order to assess the most appropriate way to protect women and foetus from malaria infection, i.e. weekly prophylaxis or mild malaria attack treatment, both by chloroquine. By realizing a randomized and multicentric clinical trial on 800 women in each group, we will compare the impact on maternal malaria attack incidence rates, on proportions of mothers with anaemia, on low-birth weight and on positive parasitaemias during pregnancy and at delivery, of weekly prophylaxis and mild malaria attack diagnosis and treatment. The study will be undertaken during 18 months in the region of Santa Cruz and will give important information to the Bolivian Ministry of Health for establishing national recommendations.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnancy between 4 to 36 weeks of gestation
- •Intention to deliver at the maternity clinics
- •Residence near the maternity clinics
- •Written informed consent (parents or tutors if aged<18 years)
排除标准
- •Pregnancy prior to 4 weeks or after 36 weeks of gestation
- •Allergy to chloroquine
- •Clinical signs of hepatic or renal alteration
- •Inability to take drugs by oral route
- •Presence of effective uterine contractions
研究组 & 干预措施
Chloroquine profilaxis
Prevention: chloroquine profilaxis
Prevention of malaria attacks with chloroquine profilaxis taken once a week
干预措施: Chloroquine profilaxis (Drug)
结局指标
主要结局
Incidence of women presenting a malaria attack during pregnancy
时间窗: two years
次要结局
- proportions of mothers with placental plasmodial infection(2 years)
- proportions of mothers with moderate to severe anaemia (<8g/dl) at delivery(2 years)
- maternal haemoglobin rate at delivery(2 years)
- proportions of women with parasitaemia during pregnancy and at delivery(2 years)
- mean parasites densities of women with parasitaemia during pregnancy and at delivery(2 years)
- proportions of children with low birthweight (<2,500 grams)(2 years)
- mean birthweight(2 years)
- proportions of preterm deliveries(2 years)
研究者
Bernadette Murgue
administrative responsible for IRD
Institut de Recherche pour le Developpement
