Prevention of P. Vivax Malaria During Pregnancy in Bolivia

Phase 4

Withdrawn

• Conditions: Malaria
• Interventions: Drug: Chloroquine profilaxis

• Registration Number: NCT00290420
• Lead Sponsor: Institut de Recherche pour le Developpement

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.

Study Timeline

• Study First Submitted: 2006-02-09
• Study First Submitted QC: 2006-02-09
• Study First Posted: 2006-02-13
• Study Start: 2006-03
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-21
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chloroquine profilaxis	Chloroquine profilaxis	Prevention: chloroquine profilaxis Prevention of malaria attacks with chloroquine profilaxis taken once a week

Primary Outcome Measures

Name	Time	Method
Incidence of women presenting a malaria attack during pregnancy	two years

Secondary Outcome Measures

Name	Time	Method
mean parasites densities of women with parasitaemia during pregnancy and at delivery	2 years
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
proportions of children with low birthweight (<2,500 grams)	2 years
mean birthweight	2 years
proportions of preterm deliveries	2 years