[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552071":3},{"organization":4,"outcomesModule":7,"designInfo":74,"detailedDescription":77,"studyPopulation":78,"armGroups":79,"interventions":30,"overallOfficials":89,"centralContacts":97,"locations":106,"responsibleParty":122,"collaborators":124,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":30,"eligibilityCriteria":135,"healthyVolunteers":136,"sex":137,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":143,"studyType":144,"phases":30,"briefSummary":145,"conditions":146,"keywords":30,"overallStatus":109,"whyStopped":30,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"primaryOutcomes":8,"secondaryOutcomes":46,"otherOutcomes":30},[9,13,16,19,22,25,28,31,34,37,40,43],{"measure":10,"description":11,"timeFrame":12},"Number of pregnancies","Detected by urine or serum by active and passive screening","Through study completion, an average of 1 year",{"measure":14,"description":15,"timeFrame":12},"Number of malaria cases","Detected by RDT and\u002For blood smear and\u002For PCR during pregnancy defined as any parasitemia with or without malaria symptoms",{"measure":17,"description":18,"timeFrame":12},"Incidence of placental malaria","Detected by blood smear or pathology\u002Fhistology, at delivery",{"measure":20,"description":21,"timeFrame":12},"Use of other malaria prevention tools","Recorded by survey",{"measure":23,"description":24,"timeFrame":12},"Number of Participants with anemia during pregnancy and post-partum","Defined as hemoglobin level less than 11 g\u002FdL",{"measure":26,"description":27,"timeFrame":12},"Dating of pregnancies","Measured at each ANC visit by ultrasound and last menstrual period",{"measure":29,"description":30,"timeFrame":12},"Number of Maternal Deaths",null,{"measure":32,"description":33,"timeFrame":12},"Number of fetal Losses and Stillbirths","Pregnancies terminated in the first trimester (\\\u003C=12 weeks) and in the second trimester (\\>12 and \\\u003C28 weeks) and stillbirth",{"measure":35,"description":36,"timeFrame":12},"Number of multiple gestations","Twins, triplets, or multiple gestations during pregnancy",{"measure":38,"description":39,"timeFrame":12},"Incidence of preterm delivery","Preterm delivery (≥28 to \\\u003C37 weeks)",{"measure":41,"description":42,"timeFrame":12},"Occurrence of chronic medical conditions","Description and reporting of occurrence of chronic medical conditions during pregnancy and\u002For post-partum",{"measure":44,"description":45,"timeFrame":12},"Occurrence of pregnancy and post-partum adverse outcomes","Description and reporting of occurrence of pregnancy and post-partum adverse outcomes including but not limited to gestational diabetes, gestational hypertension, pre-eclampsia, eclampsia, postpartum hemorrhage, and postpartum depression",[47,50,53,56,59,62,65,68,71],{"measure":48,"description":49,"timeFrame":12},"Number of neonatal deaths","Neonatal death as defined as early (≤7 days) or late (\\>7 days ≤28 days) after delivery",{"measure":51,"description":52,"timeFrame":12},"Incidence of low Birth Weight (LBW)","LBW as defined as \\\u003C2.5 kg at birth",{"measure":54,"description":55,"timeFrame":12},"Incidence of preterm birth","Preterm birth (≥28 to \\\u003C37 weeks)",{"measure":57,"description":58,"timeFrame":12},"Occurrence and description of malformations","Occurrence and description of malformations identified at delivery and within the first 6 months of life",{"measure":60,"description":61,"timeFrame":12},"Occurrence of Small for Gestational Age (SGA)","defined as newborns whose birth weight is \\\u003C10th percentile for gestational age as defined by INTERGROWTH-21st international standards",{"measure":63,"description":64,"timeFrame":12},"Occurrence of malaria (symptomatic and asymptomatic) in neonates and infants","Detected by RDT and\u002For blood smear and\u002For PCR at birth and throughout first year of life defined as any parasitemia with or without malaria symptoms",{"measure":66,"description":67,"timeFrame":12},"Occurrence of anemia during infancy at 6 and 12 months of age","Anemia during infancy as defined by age of testing",{"measure":69,"description":70,"timeFrame":12},"Occurrence of neonatal\u002Finfant\u002Fpediatric adverse outcomes","Description and reporting of occurrence of neonatal\u002Finfant\u002Fpediatric adverse outcomes",{"measure":72,"description":73,"timeFrame":12},"Timing of receipt of routine vaccinations","Reporting and timing of receipt of routine vaccinations, including malaria vaccines, and other standard of care anti-malarial treatment",{"allocation":30,"interventionModel":30,"interventionModelDescription":30,"primaryPurpose":30,"observationalModel":75,"timePerspective":76,"maskingInfo":30},"COHORT","PROSPECTIVE","This pregnancy registry will gather background data on pregnancy rates and outcomes as well as infant health data to inform future implementation of clinical trials testing monoclonal antibodies (mAbs) to prevent malaria in pregnancy.\n\nIn the first part of the study (Community Census Cohort), women of child-bearing age (WOCBA) in the community will be identified and followed for up to 3 years to detect pregnancy at all stages. Upon detection of pregnancy, these women may then transition to participation in the Health Facility Cohort.\n\nIn the second part of the study (Health Facility Cohort), data will be prospectively collected from pregnant women presenting at the health facility for antenatal care (ANC) visits or referred in from the Community Census Cohort. The pregnant women will be followed through pregnancy outcome and until 12 months postpartum, and their infant(s) will be followed until 12 months of age.\n\nThe study team will collect baseline information in a systematic manner on early pregnancy events, pregnancy and postpartum complications and outcomes, utilization of existing malaria prevention tools, malaria infections and clinical disease, birth outcomes, and follow-up of subsequent offspring.","Malian females of childbearing age (15-49 years) Community Census Cohort: 4000 unique women Health Facility Cohort: 2500 unique women (inclusive of women who transition for enrollment from the Community Census Cohort)\n\nOffspring from Health Facility Cohort: 3000 children",[80,83,86],{"label":81,"type":30,"description":82,"interventionNames":30},"Community Census Cohort","Women of child-bearing aged (WOCBA) identified within the community.",{"label":84,"type":30,"description":85,"interventionNames":30},"Health Facility Cohort","Pregnant women presenting at the health facility for antenatal care or referred in from the Community Consensus Cohort.",{"label":87,"type":30,"description":88,"interventionNames":30},"Offspring from Health Facility Cohort","Children born to women in the health facility cohort.",[90,94],{"name":91,"affiliation":92,"role":93},"Kassoum Kayentao, MD, MPH, PhD","Faculté de Médecine Pharmacie d'Odontostomatologie (FMOS)","PRINCIPAL_INVESTIGATOR",{"name":95,"affiliation":96,"role":93},"Peter Crompton, MD, MPH","National Institutes of Health (NIH)",[98,102],{"name":91,"role":99,"phone":100,"phoneExt":30,"email":101},"CONTACT","+223 7646 0173","kayentao@icermali.org",{"name":103,"role":99,"phone":104,"phoneExt":30,"email":105},"Boubacar Traore, PharmD, PhD","+223 20 22 14 17","bouba.traore@mrtcbko.org",[107],{"facility":108,"status":109,"city":110,"state":111,"zip":30,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":119,"contacts":120},"Kalifabougou MRTC Clinic","RECRUITING","Kalifabougou","Koulikoro","Mali","ML",{"type":115,"coordinates":116},"Point",[117,118],-8.17437,12.94879,{"lat":118,"lon":117},[121],{"name":91,"role":99,"phone":100,"phoneExt":30,"email":101},{"type":123,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[125,126],{"name":96,"class":6},{"name":127,"class":128},"University of Washington","OTHER","100552071","pregnancy-registry-in-mali-100552071",false,"NCT06468319","Pregnancy Registry in Mali","Assessment of Pregnancy Outcomes Through Demographic Surveillance and Prospective Data Collection at a Health Facility in Kalifabougou, Mali","Inclusion Criteria:\n\nCommunity Census Cohort:\n\n1. Females of childbearing potential or pregnant females.\n2. Aged 15 to 49 years.\n3. Able to provide verbal individual informed consent.\n\nHealth Facility Cohort:\n\n1. Pregnant females 15 to 49 years and their subsequent offspring.\n2. Resides in or in the health catchment area of Kalifabougou and willing to return to the health center for Antenatal Care (ANC) visits.\n3. Able to provide written individual informed consent for herself and her future offspring(s).\n\nExclusion Criteria:\n\nCommunity Census Cohort:\n\n1. Temporary residence in the study area.\n2. Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of an individual participating in the study, interfere with the evaluation of the study objectives, or render the participant unable to comply with the protocol.\n\nHealth Facility Cohort:\n\n1. Temporary residence in the study area.\n2. Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of an individual participating in the study, interfere with the evaluation of the study objectives, or render the participant unable to comply with the protocol.",true,"FEMALE","15 Years","49 Years",{"count":141,"type":142},9500,"ESTIMATED","5 Years","OBSERVATIONAL","This registry will assess pregnancy outcomes through demographic surveillance and prospective data collection at a health facility in Kalifabougou, Mali.",[147,148],"Malaria","Pregnancy Related","2026-03-11",{"date":151,"type":152},"2026-03-13","ACTUAL",{"date":154,"type":152},"2024-08-05",{"date":156,"type":142},"2030-06",{"name":5,"class":6},1]