Prevention of P. Vivax Malaria During Pregnancy in Bolivia

Condition(s) targeted: Malaria

Intervention: Chloroquine profilaxis (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: Institut de Recherche pour le Developpement

Official(s) and/or principal investigator(s):
Michel Cot, MD-PhD, Study Director, Affiliation: Institut de Recherche pour le Developpement
Laurent Brutus, MD-MSc, Study Director, Affiliation: Institut de Recherche pour le Développement, IRD, Bolivia
Agnès Le Port, MSc, Principal Investigator, Affiliation: Institut de Recherche pour le Développement, IRD, Bolivia

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Incidence of women presenting a malaria attack during pregnancy

Secondary outcome:

proportions of mothers with placental plasmodial infection

proportions of mothers with moderate to severe anaemia (<8g/dl) at delivery

maternal haemoglobin rate at delivery

proportions of women with parasitaemia during pregnancy and at delivery

mean parasites densities of women with parasitaemia during pregnancy and at delivery

proportions of children with low birthweight (<2,500 grams)

mean birthweight

proportions of preterm deliveries

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

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

Starting date: March 2006
Last updated: May 21, 2013