Malaria
Conditions
Keywords
malaria, Plasmodium vivax, pregnancy, chemoprophylaxis
Brief summary
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.
Detailed description
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.
Interventions
DRUGChloroquine profilaxis
Prevention: Give a profilaxis with chloroquine once a week to prevent Plasmodium vivax malaria attacks and to prevent harmfull effect on birth outcomes
Sponsors
Instituto Nacional de Laboratorios de Salud (INLASA)
Pan American Health Organization
Ministry of Health, Bolivia
Institut de Recherche pour le Developpement
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of women presenting a malaria attack during pregnancy | two years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| proportions of mothers with placental plasmodial infection | 2 years |
| proportions of children with low birthweight (<2,500 grams) | 2 years |
| mean birthweight | 2 years |
| proportions of preterm deliveries | 2 years |
| mean parasites densities of women with parasitaemia during pregnancy and at delivery | 2 years |
Outcome results
None listed