Prevention of P. Vivax Malaria During Pregnancy in Bolivia

NCT00290420 | Withdrawn Phase 4

• 1 other identifier: IRD/Prevmal/Bol/06
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malaria

Keywords

malaria; Plasmodium vivax; pregnancy; chemoprophylaxis

Outcome Measures

Primary Outcomes (1)

• Incidence of women presenting a malaria attack during pregnancy

  two years

Secondary Outcomes (8)

• 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

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

  2 years

Study Arms (2)

Chloroquine profilaxis

EXPERIMENTAL

Prevention: chloroquine profilaxis Prevention of malaria attacks with chloroquine profilaxis taken once a week

Drug: Chloroquine profilaxis

No prevention

NO INTERVENTION

Treatment of malaria attack with chloroquine when they occur

Interventions

Chloroquine profilaxis DRUG

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

Also known as: prevention of plasmodium vivax malaria harmfull effects on birth outcomes

Chloroquine profilaxis

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Recherche pour le Developpement: lead
• Instituto Nacional de Laboratorios de Salud (INLASA): collaborator
• Pan American Health Organization: collaborator
• Ministry of Health, Bolivia: collaborator

MeSH Terms

Conditions

Malaria; Malaria, Vivax

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Michel Cot, MD-PhD

  Institut de Recherche pour le Developpement

  STUDY DIRECTOR

• Laurent Brutus, MD-MSc

  Institut de Recherche pour le Développement, IRD, Bolivia

  STUDY DIRECTOR

• Agnès Le Port, MSc

  Institut de Recherche pour le Développement, IRD, Bolivia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: administrative responsible for IRD

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 13, 2006
• Study Start: March 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 22, 2013

Record last verified: 2013-05