Prevention of P. Vivax Malaria During Pregnancy in Bolivia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-11-30

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.

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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.

Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Chloroquine profilaxis

Prevention: chloroquine profilaxis

Prevention of malaria attacks with chloroquine profilaxis taken once a week

Group Type EXPERIMENTAL

Chloroquine profilaxis

Intervention Type DRUG

Prevention:

Give a profilaxis with chloroquine once a week to prevent Plasmodium vivax malaria attacks and to prevent harmfull effect on birth outcomes

No prevention

Treatment of malaria attack with chloroquine when they occur

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Chloroquine profilaxis

Prevention:

Give a profilaxis with chloroquine once a week to prevent Plasmodium vivax malaria attacks and to prevent harmfull effect on birth outcomes

Intervention Type DRUG

Other Intervention Names

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prevention of plasmodium vivax malaria harmfull effects on birth outcomes

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes