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Prevention of P. Vivax Malaria During Pregnancy in Bolivia

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ClinicalTrials.gov Identifier: NCT00290420
Recruitment Status : Withdrawn (important delays and malaria season missed, due to political changes)
First Posted : February 13, 2006
Last Update Posted : May 22, 2013
Sponsor:
Collaborators:
Instituto Nacional de Laboratorios de Salud (INLASA)
Pan American Health Organization
Ministry of Health, Bolivia
Information provided by (Responsible Party):
Bernadette Murgue, 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.

Condition or disease Intervention/treatment Phase
Malaria Drug: Chloroquine profilaxis Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : March 2006
Estimated Primary Completion Date : November 2007
Estimated Study Completion Date : November 2007


Arm Intervention/treatment
Experimental: Chloroquine profilaxis

Prevention: chloroquine profilaxis

Prevention of malaria attacks with chloroquine profilaxis taken once a week

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

Other Name: prevention of plasmodium vivax malaria harmfull effects on birth outcomes

No Intervention: No prevention
Treatment of malaria attack with chloroquine when they occur



Primary Outcome Measures :
  1. Incidence of women presenting a malaria attack during pregnancy [ Time Frame: two years ]

Secondary Outcome Measures :
  1. proportions of mothers with placental plasmodial infection [ Time Frame: 2 years ]
  2. proportions of mothers with moderate to severe anaemia (<8g/dl) at delivery [ Time Frame: 2 years ]
  3. maternal haemoglobin rate at delivery [ Time Frame: 2 years ]
  4. proportions of women with parasitaemia during pregnancy and at delivery [ Time Frame: 2 years ]
  5. mean parasites densities of women with parasitaemia during pregnancy and at delivery [ Time Frame: 2 years ]
  6. proportions of children with low birthweight (<2,500 grams) [ Time Frame: 2 years ]
  7. mean birthweight [ Time Frame: 2 years ]
  8. proportions of preterm deliveries [ Time Frame: 2 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290420


Sponsors and Collaborators
Institut de Recherche pour le Developpement
Instituto Nacional de Laboratorios de Salud (INLASA)
Pan American Health Organization
Ministry of Health, Bolivia
Investigators
Study Director: Michel Cot, MD-PhD Institut de Recherche pour le Developpement
Study Director: Laurent Brutus, MD-MSc Institut de Recherche pour le Développement, IRD, Bolivia
Principal Investigator: Agnès Le Port, MSc Institut de Recherche pour le Développement, IRD, Bolivia

Responsible Party: Bernadette Murgue, administrative responsible for IRD, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT00290420     History of Changes
Other Study ID Numbers: IRD/Prevmal/Bol/06
First Posted: February 13, 2006    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: May 2013

Keywords provided by Bernadette Murgue, Institut de Recherche pour le Developpement:
malaria
Plasmodium vivax
pregnancy
chemoprophylaxis

Additional relevant MeSH terms:
Chloroquine
Chloroquine diphosphate
Malaria
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics