[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516496":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":23,"locations":32,"responsibleParty":50,"collaborators":54,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":10,"studyType":75,"phases":10,"briefSummary":76,"conditions":77,"keywords":10,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University of Manchester","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cases",null,"Recently pregnant women\u002Fpeople who have experienced baby loss during pregnancy, labour or shortly after birth between 20-28 weeks of pregnancy",[13],"Other: Questionnaire",{"label":15,"type":10,"description":16,"interventionNames":17},"Controls","Individuals still pregnant at same gestational age",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"Questionnaire","Interviewer assisted completion of questionnaire.",[9,15],[24,29],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Alexander E Heazell, PhD","CONTACT","+441612646484","alexander.heazell@manchester.ac.uk",{"name":30,"role":26,"phone":10,"phoneExt":10,"email":31},"Lucy Higgins, PhD","lucy.higgins@manchester.ac.uk",[33],{"facility":34,"status":35,"city":36,"state":10,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Manchester University NHS Foundation Trust","RECRUITING","Manchester","M13 9WL","United Kingdom","UK",{"type":41,"coordinates":42},"Point",[43,44],-2.23743,53.48095,{"lat":44,"lon":43},[47],{"name":48,"role":26,"phone":49,"phoneExt":10,"email":10},"Linda Peacock, RM","01617016965",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Dr Alexander Heazell","Professor of Obstetrics",[55,57,59],{"name":56,"class":6},"University of Birmingham",{"name":58,"class":6},"University of Leicester",{"name":60,"class":6},"University of Leeds","100516496","mothers-working-to-prevent-early-stillbirth-study-20-28-100516496",false,"NCT06005272","Mothers Working to Prevent Early Stillbirth Study 20-28","MiNESS20-28","Cases\n\n* Bereaved mothers\u002Fparents who have recently birthed a singleton baby who died before\u002Fduring or immediately after labour between 20 and 28 weeks of pregnancy.\n* Baby has no evidence of congenital anomaly\n* Able to give written informed consent\n\nControls\n\n* Pregnant women\u002Fpeople with an ongoing pregnancy (at the target gestation) receiving antenatal care from a participating maternity unit, at a gestation matched to the distribution of stillbirths between 20 to 28 weeks of pregnancy in the same unit\n* Baby has no evidence of congenital anomaly\n* Able to give written informed consent",true,"FEMALE","16 Years","50 Years",{"count":73,"type":74},948,"ESTIMATED","OBSERVATIONAL","This project aims to identify factors linked to pregnancy losses occurring between 20 and 28 weeks of pregnancy that can be modified by changing mother's behaviour or healthcare provision.\n\nThe death of a child before birth (also called stillbirth or miscarriage) has enduring psychological, social and economic effects for women, their families and wider society. In 2015, the stillbirth rate in the UK was higher than comparable countries. The UK government has committed to reduce stillbirths by 50% by 2025. Presently, stillbirths after 28 weeks of pregnancy have reduced by 16% but there has been no change in losses between 20 and 28 weeks of pregnancy with 1,600 losses estimated to occur at this stage of pregnancy each year.\n\nIdentification of modifiable causes of stillbirth was identified as a research priority by the Stillbirth Priority Setting Partnership which involved over 1,000 participants, one third of whom were bereaved parents. The investigators previously completed a study of 291 women who had a late stillbirth (after 28 weeks of pregnancy) and 733 women who had a live baby in 41 maternity units in the UK. This study identified factors linked to stillbirth which can be changed including the position women go to sleep in, cigarette smoking and caffeine consumption. In addition, the investigators previously found changes in mother's perception of baby's movements, whether women had tests for diabetes or whether women were exposed to domestic violence or stressful situations. These factors can be addressed by different care in pregnancy. Information from this study has been included in national and international guidelines that aim to reduce stillbirth.\n\nThe investigators will use the same study type to identify factors associated with pregnancy loss between 20 and 28 weeks of pregnancy (early stillbirth). The investigators have asked parents who have experienced the death of a baby at these stages of pregnancy about the design of the study, the questions that would be asked and how best to approach bereaved parents. This led us to include miscarriages from 20-22 weeks of pregnancy that are not usually \"counted\" in UK stillbirth statistics. The investigators will need 316 women with stillbirth between 20 and 28 weeks of pregnancy and 632 women with an ongoing live pregnancy to participate in the study. All women will complete a questionnaire about themselves, their diet, behaviours and sleep, their baby's movements and pregnancy care. The investigators will compare information between women who have early stillbirth and those who have a live birth to identify factors associated with stillbirth at less than 28 weeks of pregnancy. The study findings will be disseminated in collaboration with patient organisations using effective ways to reach pregnant women. The investigators anticipate the findings from this study will be included in clinical practice guidelines and rapidly translated into antenatal care.",[78,79],"Stillbirth and Fetal Death","Perinatal Death","2026-02-24",{"date":82,"type":83},"2026-02-27","ACTUAL",{"date":85,"type":83},"2023-09-01",{"date":87,"type":74},"2027-03-31",{"name":5,"class":6},1]