Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-24 @ 2:59 PM
Study NCT ID:
NCT01255605
Status:
COMPLETED
Last Update Posted:
2012-06-18
First Post:
2010-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of IPT With Sulfadoxin Pyrimetamin on Pregnant Women and Their Babies Outcomes in Peri-urban Areas of Bobo-Dioulasso(Burkina Faso)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}], '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The investigators make thick and thin blood smear and collect a few drops of blood on the 3MM paper Whatmann Schleicher-Schuell.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 772}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-15', 'studyFirstSubmitDate': '2010-12-06', 'studyFirstSubmitQcDate': '2010-12-06', 'lastUpdatePostDateStruct': {'date': '2012-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peripheral and placental malaria', 'timeFrame': 'Peripheral malaria : at antenatal clinics and at delivery. Placental malaria: at delivery', 'description': 'The investigators will check if pregnant women have any malaria parasites by making a finger prick thick respectively at antenatal clinics and at delivery. A placental thin smear will be made at delivery.'}], 'secondaryOutcomes': [{'measure': 'Maternal anemia, congenital malaria,low birth weight, prematurity.', 'timeFrame': 'Maternal anemia: at antenatal clinics and at delivery. Congenital malaria: at delivery. Low birth weight: at delivery. Prematurity: at delivery.', 'description': 'The investigators will check pregnant women haemoglobin level.A level\\< 11g/dl will be considered as anemia.\n\nCongenital malaria will be assessed through cord blood smear. Birth weight \\<2500g will be considered as low birth weight. Prematurity designs any birth before 37 gestation weeks.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intermittent preventive treatment with sulfadoxin-pyrimethamine', 'in Bobo-Dioulasso peri-urban areas, 5 years after its implementation', 'Burkina Faso.'], 'conditions': ['Malaria, Pregnancy']}, 'descriptionModule': {'briefSummary': 'The purpose of this is to determine the impact of intermittent preventive treatment (IPT) with sulfadoxine-pyrimethamine (SP) on the morbidities associated with malaria in pregnant women and newborns in rural peri-urban areas of Bobo-Dioulasso, 5 years after its implemented.', 'detailedDescription': 'Malaria in pregnant women is a crucial issue in Burkina Faso. Faced with this problem, a strategy based on the use of treated nets and intermittent preventive treatment (IPT) based on sulfadoxine-pyrimethamine (SP) was adopted in 2005. Five years after its implementation, the investigators will check whether this strategy is still effective in the preventing maternal and congenital malaria on the one hand and maternal anemia, low birth weight and prematurity on the other hand.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Our study population is constitued by pregnant women coming for antenatal care or delivery in two peripheral heath facilities of Bobo-Dioulasso(Lafiabougou and Secteur 24).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Residing in the health area of Lafiabougou or secteur 24\n* Having agreed to give free and informed consent\n\nExclusion Criteria:\n\n* Bleeding from during the pregnancy\n* eclampsia'}, 'identificationModule': {'nctId': 'NCT01255605', 'briefTitle': 'Impact of IPT With Sulfadoxin Pyrimetamin on Pregnant Women and Their Babies Outcomes in Peri-urban Areas of Bobo-Dioulasso(Burkina Faso)', 'organization': {'class': 'OTHER', 'fullName': 'Université Polytechnique de Bobo-Dioulasso'}, 'officialTitle': 'Impact of Intermittent Preventive Treatment (IPT) With Sulfadoxine-pyrimethamine (SP) on the Morbidities Associated With Malaria in Pregnant Women and Newborns in Peri-urban Areas of Bobo-Dioulasso, 5 Years After Its Adoption by the National Program for Fight Against Malaria in Burkina Faso.', 'orgStudyIdInfo': {'id': 'PIC/INSSA/UPB-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '1091', 'city': 'Bobo-Dioulasso', 'state': 'Houet', 'country': 'Burkina Faso', 'facility': 'Institut Supérieur des Sciences de la Santé/Université Polytechnique de Bobo-Dioulasso', 'geoPoint': {'lat': 11.18064, 'lon': -4.29489}}], 'overallOfficials': [{'name': 'Mamoudou Cisse, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre MURAZ Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université Polytechnique de Bobo-Dioulasso', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Dr Mamoudou Cisse', 'investigatorAffiliation': 'Centre Muraz'}}}}