Prevention of P. Vivax Malaria During Pregnancy in Bolivia

Malaria Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00290420
• Other study ID #: IRD/Prevmal/Bol/06
• Status: Withdrawn
• Phase: Phase 4
• First received: February 9, 2006
• Last updated: May 21, 2013
• Start date: March 2006
• Est. completion date: November 2007

Study information

• Verified date: May 2013
• Source: Institut de Recherche pour le Developpement
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministère de l'Enseignement supérieur et de la Recherche
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• Malaria
• Malaria, Vivax

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Institut de Recherche pour le Developpement	Instituto Nacional de Laboratorios de Salud (INLASA), Ministry of Health, Bolivia, Pan American Health Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of women presenting a malaria attack during pregnancy		two years	Yes
Secondary	proportions of mothers with placental plasmodial infection		2 years	Yes
Secondary	proportions of mothers with moderate to severe anaemia (<8g/dl) at delivery		2 years	Yes
Secondary	maternal haemoglobin rate at delivery		2 years	Yes
Secondary	proportions of women with parasitaemia during pregnancy and at delivery		2 years	Yes
Secondary	mean parasites densities of women with parasitaemia during pregnancy and at delivery		2 years	No
Secondary	proportions of children with low birthweight (<2,500 grams)		2 years	Yes
Secondary	mean birthweight		2 years	No
Secondary	proportions of preterm deliveries		2 years	Yes