Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT00290420
Status:
WITHDRAWN
Last Update Posted:
2013-05-22
First Post:
2006-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of P. Vivax Malaria During Pregnancy in Bolivia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Bolivia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}, {'id': 'D016780', 'term': 'Malaria, Vivax'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'important delays and malaria season missed, due to political changes', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2007-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-21', 'studyFirstSubmitDate': '2006-02-09', 'studyFirstSubmitQcDate': '2006-02-09', 'lastUpdatePostDateStruct': {'date': '2013-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of women presenting a malaria attack during pregnancy', 'timeFrame': 'two years'}], 'secondaryOutcomes': [{'measure': 'proportions of mothers with placental plasmodial infection', 'timeFrame': '2 years'}, {'measure': 'proportions of mothers with moderate to severe anaemia (<8g/dl) at delivery', 'timeFrame': '2 years'}, {'measure': 'maternal haemoglobin rate at delivery', 'timeFrame': '2 years'}, {'measure': 'proportions of women with parasitaemia during pregnancy and at delivery', 'timeFrame': '2 years'}, {'measure': 'mean parasites densities of women with parasitaemia during pregnancy and at delivery', 'timeFrame': '2 years'}, {'measure': 'proportions of children with low birthweight (<2,500 grams)', 'timeFrame': '2 years'}, {'measure': 'mean birthweight', 'timeFrame': '2 years'}, {'measure': 'proportions of preterm deliveries', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['malaria', 'Plasmodium vivax', 'pregnancy', 'chemoprophylaxis'], 'conditions': ['Malaria']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnancy between 4 to 36 weeks of gestation\n* Intention to deliver at the maternity clinics\n* Residence near the maternity clinics\n* Written informed consent (parents or tutors if aged\\<18 years)\n\nExclusion Criteria:\n\n* Pregnancy prior to 4 weeks or after 36 weeks of gestation\n* Allergy to chloroquine\n* Clinical signs of hepatic or renal alteration\n* Inability to take drugs by oral route\n* Presence of effective uterine contractions'}, 'identificationModule': {'nctId': 'NCT00290420', 'briefTitle': 'Prevention of P. Vivax Malaria During Pregnancy in Bolivia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut de Recherche pour le Developpement'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'IRD/Prevmal/Bol/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chloroquine profilaxis', 'description': 'Prevention: chloroquine profilaxis\n\nPrevention of malaria attacks with chloroquine profilaxis taken once a week', 'interventionNames': ['Drug: Chloroquine profilaxis']}, {'type': 'NO_INTERVENTION', 'label': 'No prevention', 'description': 'Treatment of malaria attack with chloroquine when they occur'}], 'interventions': [{'name': 'Chloroquine profilaxis', 'type': 'DRUG', 'otherNames': ['prevention of plasmodium vivax malaria harmfull effects on birth outcomes'], 'description': 'Prevention:\n\nGive a profilaxis with chloroquine once a week to prevent Plasmodium vivax malaria attacks and to prevent harmfull effect on birth outcomes', 'armGroupLabels': ['Chloroquine profilaxis']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michel Cot, MD-PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut de Recherche pour le Developpement'}, {'name': 'Laurent Brutus, MD-MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut de Recherche pour le Développement, IRD, Bolivia'}, {'name': 'Agnès Le Port, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de Recherche pour le Développement, IRD, Bolivia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Recherche pour le Developpement', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Instituto Nacional de Laboratorios de Salud (INLASA)', 'class': 'UNKNOWN'}, {'name': 'Pan American Health Organization', 'class': 'OTHER'}, {'name': 'Ministry of Health, Bolivia', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'administrative responsible for IRD', 'investigatorFullName': 'Bernadette Murgue', 'investigatorAffiliation': 'Institut de Recherche pour le Developpement'}}}}