[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476574":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":33,"responsibleParty":62,"collaborators":64,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":10,"studyType":84,"phases":10,"briefSummary":85,"conditions":86,"keywords":92,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University of Oxford","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Perinatal women",null,"Women will be recruited in their first trimester of pregnancy and followed-up until 6 months post-partum. This is the 'exposed' group.",[13],"Diagnostic Test: Screening tools for common mental disorders",{"label":15,"type":10,"description":16,"interventionNames":17},"Non-perinatal women","Non-perinatal women will be recruited as the 'non-exposed' group and followed-up over the same duration as the perinatal group.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","Screening tools for common mental disorders","A number of screening tools will be administered which will establish the likelihood of depression, anxiety, PTSD, somatisation and suicidality.",[15,9],[25],{"name":26,"affiliation":5,"role":27},"Gracia Fellmeth, DPhil","PRINCIPAL_INVESTIGATOR",[29],{"name":26,"role":30,"phone":31,"phoneExt":10,"email":32},"CONTACT","00441865289745","gracia.fellmeth@ndph.ox.ac.uk",[34,50],{"facility":35,"status":36,"city":37,"state":38,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Dr Rajendra Prasad Government Medical College","RECRUITING","Kangra","Himachal Pradesh","India","IN",{"type":42,"coordinates":43},"Point",[44,45],76.26267,32.09135,{"lat":45,"lon":44},[48],{"name":49,"role":30,"phone":10,"phoneExt":10,"email":10},"Ashok Verma",{"facility":51,"status":36,"city":52,"state":53,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"National Institute of Mental Health and Neuro Sciences","Bengaluru","Karnataka",{"type":42,"coordinates":55},[56,57],77.59369,12.97194,{"lat":57,"lon":56},[60],{"name":61,"role":30,"phone":10,"phoneExt":10,"email":10},"M. Thomas Kishore",{"type":63,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[65,67],{"name":66,"class":6},"National Institute of Mental Health and Neuro Sciences, India",{"name":68,"class":6},"Dr. Rajendra Prasad Government Medical College","100476574","perinatal-mental-health-study-pmhs-india-100476574",false,"NCT05485701","Perinatal Mental Health Study (PMHS) India","Perinatal Mental Health Study (PMHS): a Cohort and Validation Study in Two Low-income Settings in India","PMHS","Inclusion Criteria:\n\nFor Phase 1 (qualitative study) and Phase 2 (validation study):\n\nPregnant women:\n\n* Aged 18 to 45 years\n* Currently pregnant (any trimester)\n* Willing and able to give informed consent\n\nPost-partum women:\n\n* Aged 18 to 45 years\n* Currently post-partum (between 1-12 months postpartum)\n* Willing and able to give informed consent\n\nNon-perinatal women:\n\n* Aged 18 to 45 years\n* Not currently pregnant and not given birth in the past 12 months\n* Willing and able to give informed consent\n\nFor Phase 3 (prospective cohort study):\n\nPerinatal women:\n\n* Aged 18 to 45 years\n* In early pregnancy (estimated gestational age \\\u003C20 weeks) at recruitment\n* Not planning to relocate for the duration of the study period\n* Willing and able to give informed consent\n* Expressed a willingness to continue to participate for the four planned visits\n\nNon-perinatal women:\n\n* Aged 18 to 45 years\n* Not currently pregnant and not given birth in the last 12 months\n* Not planning to relocate for the duration of the study period\n* Willing and able to give informed consent\n* Expressed a willingness to continue to participate for the four planned visits\n\nExclusion Criteria:\n\nThe participant may not enter the study if:\n\n* They have an acutely severe psychiatric illness which impairs their ability to take part in the study\n* They are not willing or able to provide informed consent\n\nOther than for current severe psychiatric illness which affects ability to participate in the study, we will not exclude any participant on the basis of current or prior physical, psychological or psychiatric co-morbidities so long as she is willing to participate, her ability to take part is not compromised and her ability to give informed consent is not impaired by these conditions.",true,"FEMALE","18 Years","45 Years",{"count":82,"type":83},2332,"ESTIMATED","OBSERVATIONAL","The purpose of this observational study is to improve understanding of mental disorders among perinatal women in India.",[87,88,89,90,91],"Depression","Anxiety","Suicidal Ideation","Somatization","PTSD",[93,94,95,96,39,97,98,99,100,101],"Perinatal","Post-partum","Antenatal","Low- and middle-income country","Common mental disorders","Screening","Validation","Prevalence","Risk factor","2023-11-30",{"date":104,"type":105},"2023-12-07","ACTUAL",{"date":107,"type":105},"2022-09-01",{"date":109,"type":83},"2026-08-31",{"name":5,"class":6},2]