Prevention of P. Vivax Malaria During Pregnancy in Bolivia

This study has been withdrawn prior to enrollment.
(important delays and malaria season missed, due to political changes)
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
ClinicalTrials.gov Identifier:
NCT00290420
First received: February 9, 2006
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Malaria
Drug: Chloroquine profilaxis
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Institut de Recherche pour le Developpement:

Primary Outcome Measures:
  • Incidence of women presenting a malaria attack during pregnancy [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • proportions of mothers with placental plasmodial infection [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • proportions of mothers with moderate to severe anaemia (<8g/dl) at delivery [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • maternal haemoglobin rate at delivery [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • proportions of women with parasitaemia during pregnancy and at delivery [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • mean parasites densities of women with parasitaemia during pregnancy and at delivery [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • proportions of children with low birthweight (<2,500 grams) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • mean birthweight [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • proportions of preterm deliveries [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: March 2006
Estimated Study Completion Date: November 2007
Estimated Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: February 9, 2006
Last Updated: May 21, 2013
Health Authority: France: Ministère de l'Enseignement supérieur et de la Recherche

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

Additional relevant MeSH terms:
Malaria
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Chloroquine
Chloroquine diphosphate
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 26, 2014