Prevention of P. Vivax Malaria During Pregnancy in Bolivia

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Malaria

Intervention / Treatment
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* Drug: Chloroquine profilaxis


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chloroquine profilaxis<br>Prevention: chloroquine profilaxis Prevention of malaria attacks with chloroquine profilaxis taken once a week | Drug: Chloroquine profilaxis<br>* Prevention: Give a profilaxis with chloroquine once a week to prevent Plasmodium vivax malaria attacks and to prevent harmfull effect on birth outcomes<br>* Other names: prevention of plasmodium vivax malaria harmfull effects on birth outcomes;|
| No Intervention: No prevention<br>Treatment of malaria attack with chloroquine when they occur | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of women presenting a malaria attack during pregnancy |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malaria, Plasmodium vivax, pregnancy, chemoprophylaxis