[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Robert Colebunders\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":38},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":4},"100550087","observational-mondkeypox-pregnancy-cohort-100550087",false,"NCT06442501","Observational Mondkeypox Pregnancy Cohort","Pregnancy Monkeypox Cohort Study in the South Kivu Province in the DRC","PREGMPOXCO","Inclusion Criteria:\n\n* 1\\. Pregnancy status: all women confirmed to be pregnant at the time of recruitment.\n\n  2\\. Age: women of all age (ascent to be asked for non-legal age to allow for the pair mother-child to benefit with earlier diagnosis and other befit the study might offer).\n\n  3\\. Geographical inclusion: residing within the catchment areas of the selected healthcare facilities in South Kivu to ensure that they are likely to continue receiving follow-up care at the participating sites throughout their pregnancy.\n\n  4\\. Symptomatic and asymptomatic participation:\n  * Symptomatic: pregnant women presenting with symptoms suggestive of mpox, such as fever, rash\u002Fskin lesion, or lymphadenopathy.\n  * Asymptomatic: pregnant women attending routine antenatal visits who do not exhibit symptoms but are screened as part of the study's surveillance efforts or who report a confirmed case of mpox in the household\u002For among closed contacts 5. Consent: women who provide written informed consent to participate in the study, having understood the purpose, procedures, potential risks, and benefits of the study.\n\nExclusion Criteria:1. Non-consent: pregnant women who do not consent\u002For their parent-caregiver to participate in the study.\n\n2\\. Medical exclusions: women with pre-existing medical conditions that, as determined by clinical judgment, may either put them at risk due to participation in the study or could confound the study results (e.g., conditions that significantly alter immune response such as confirmed cancer).\n\n3\\. Plans to relocate: women who plan to move out of the geographical study area during the study period, which would interfere with follow-up.\n\n4\\. Participation in other studies: women currently participating in other clinical trials that might interfere with the results of this study, especially trials involving new experimental treatments for mpox or other infectious diseases.\n\n\\-",true,"FEMALE",{"count":20,"type":21},150,"ESTIMATED","OBSERVATIONAL","PREGMPOXCO study addresses the escalating Mpox virus (MPXV) infections among pregnant women in South Kivu, DRC following a novel MPXV sub-lineage, predominantly transmitted through heterosexual contact, stressing critical gaps in our understanding of MPXV's impact on pregnant populations. To better understand this altered transmission pattern of MPXV and its impact on this vulnerable population, PREGMPOX will employ both passive and active surveillance techniques to methodologically capture MPXV incidence among pregnant women over two years, integrating data from routine antenatal care and targeted community outreach to timely assess the MPXV's effects on maternal and neonatal health. In sentinel study sites in hot spot areas, the incidence of mpox among pregnant women will be investigated and potential transmission routes determined. MPXV(+) pregnant women will be asked to participate in a cohort study where they will be followed until delivery to document pregnancy outcomes (e.g.: miscarriage, stillbirths, preterm deliveries, neonatal mpox), maternal immune response, virus abundance and pathological changes in the placenta. This will help to determine specific risk factors and modes and frequencies of vertical transmission to the unborn, and generate a list of clinical and immunological predictors for adverse outcomes for pregnant women and neonates. Data on MVA-BN exposure will also be captured to report on its real world effectiveness. As a prerequisite to evaluate the safety of the MVA-BN vaccine and tecovirimat treatment in pregnant women according to the new DRC guidelines, we will establish a comprehensive register of adverse pregnancy outcomes, using a pharmacovigilance model to monitor and analyse adverse events following immunization and treatment. The results of our multidisciplinary studies will be crucial for developing guidelines and recommendations to manage mpox more effectively during pregnancy, and for potentially influencing global health policies.",[25],"Monkey Pox","NOT_YET_RECRUITING","2024-05-29",{"date":29,"type":30},"2024-06-04","ACTUAL",{"date":32,"type":21},"2024-10-01",{"date":34,"type":21},"2027-02-01",{"name":36,"class":37},"Robert Colebunders","OTHER",""]