Clinical trial NCT00290420: Prevention of P. Vivax Malaria During Pregnancy in Bolivia
Official title: 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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Malaria
Keywords: malaria
Plasmodium vivax
pregnancy
chemoprophylaxis
Lead sponsor: Institut de Recherche pour le Developpement
Sponsor class: OTHER_GOV
Collaborators: name: Instituto Nacional de Laboratorios de Salud (INLASA)
name: Pan American Health Organization
name: Ministry of Health, Bolivia
First posted: 2006-02-13
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of women presenting a malaria attack during pregnancy
timeFrame: two years
Secondary outcomes:
measure: proportions of mothers with placental plasmodial infection
timeFrame: 2 years
measure: proportions of mothers with moderate to severe anaemia (<8g/dl) at delivery
timeFrame: 2 years
measure: maternal haemoglobin rate at delivery
timeFrame: 2 years
measure: proportions of women with parasitaemia during pregnancy and at delivery
timeFrame: 2 years
measure: mean parasites densities of women with parasitaemia during pregnancy and at delivery
timeFrame: 2 years
measure: proportions of children with low birthweight (<2,500 grams)
timeFrame: 2 years
measure: mean birthweight
timeFrame: 2 years
measure: proportions of preterm deliveries
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Institut de Recherche pour le Developpement
name: Michel Cot, MD-PhD
role: STUDY_DIRECTOR
affiliation: Institut de Recherche pour le Développement, IRD, Bolivia
name: Laurent Brutus, MD-MSc
role: STUDY_DIRECTOR
affiliation: Institut de Recherche pour le Développement, IRD, Bolivia
name: Agnès Le Port, MSc
role: PRINCIPAL_INVESTIGATOR
References: