[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100311417":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":18,"locations":27,"responsibleParty":130,"collaborators":132,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":155,"sex":156,"minAge":157,"maxAge":18,"enrollmentInfo":158,"targetDuration":18,"studyType":161,"phases":162,"briefSummary":164,"conditions":165,"keywords":18,"overallStatus":170,"whyStopped":18,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"University of Oxford","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Self-Monitoring of Blood Pressure","EXPERIMENTAL","BUMP 1: using a validated home blood pressure monitor at least 3 times a week to record blood pressure BUMP 2: using a validated home blood pressure monitor daily to record blood pressure Women in the intervention groups will be encouraged to use a simple mobile tele monitoring system.",[13],"Other: Self-Monitoring of Blood Pressure",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","NO_INTERVENTION","Women randomised to usual care will continue to have all their BP monitoring completed by the clinical team at their antenatal assessments.",null,[20],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":18},"BUMP 1: Women randomised to the self-monitoring arm will be asked to measure blood pressures at least three times a week. They will perform two readings with a one minute interval and will be asked to act on the second reading if it falls outside their normal range thresholds described in their instructions, and aided by the tele monitoring system.\n\nBUMP 2: Women randomised to the self-monitoring arm will be asked to measure blood pressures daily. They will perform two readings with a one minute interval and will be asked to act on the second reading if it falls outside their normal range thresholds described in their instructions, aided by a tele monitoring system.",[9],[24],{"name":25,"affiliation":5,"role":26},"Richard J McManus, PhD MBBS","PRINCIPAL_INVESTIGATOR",[28,40,49,58,64,70,76,82,88,94,103,112,121],{"facility":29,"status":18,"city":30,"state":18,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":18},"Buckinghamshire Healthcare NHS Trust","Aylesbury","HP21 8AL","United Kingdom","UK",{"type":35,"coordinates":36},"Point",[37,38],-0.81458,51.81665,{"lat":38,"lon":37},{"facility":41,"status":18,"city":42,"state":18,"zip":43,"country":32,"countryCode":33,"cosmosGeoPoint":44,"geoPoint":48,"contacts":18},"Birmingham Women's and Children's Hospital NHS Foundation Trust","Birmingham","B15 2TG",{"type":35,"coordinates":45},[46,47],-1.89983,52.48142,{"lat":47,"lon":46},{"facility":50,"status":18,"city":51,"state":18,"zip":52,"country":32,"countryCode":33,"cosmosGeoPoint":53,"geoPoint":57,"contacts":18},"Croydon Health Services NHS Trust","London","CR7 7YE",{"type":35,"coordinates":54},[55,56],-0.12574,51.50853,{"lat":56,"lon":55},{"facility":59,"status":18,"city":51,"state":18,"zip":60,"country":32,"countryCode":33,"cosmosGeoPoint":61,"geoPoint":63,"contacts":18},"Barts Health NHS Trust","E1 1BB",{"type":35,"coordinates":62},[55,56],{"lat":56,"lon":55},{"facility":65,"status":18,"city":51,"state":18,"zip":66,"country":32,"countryCode":33,"cosmosGeoPoint":67,"geoPoint":69,"contacts":18},"Kingston Hospital NHS Foundation Trust","KT2 7QB",{"type":35,"coordinates":68},[55,56],{"lat":56,"lon":55},{"facility":71,"status":18,"city":51,"state":18,"zip":72,"country":32,"countryCode":33,"cosmosGeoPoint":73,"geoPoint":75,"contacts":18},"Guy's and St Thomas' NHS Foundation Trust","SE1 7EH",{"type":35,"coordinates":74},[55,56],{"lat":56,"lon":55},{"facility":77,"status":18,"city":51,"state":18,"zip":78,"country":32,"countryCode":33,"cosmosGeoPoint":79,"geoPoint":81,"contacts":18},"King's College Hospital NHS Foundation Trust","SE5 9RS",{"type":35,"coordinates":80},[55,56],{"lat":56,"lon":55},{"facility":83,"status":18,"city":51,"state":18,"zip":84,"country":32,"countryCode":33,"cosmosGeoPoint":85,"geoPoint":87,"contacts":18},"Chelsea and Westminster Hospital NHS Foundation Trust","SW10 9NH",{"type":35,"coordinates":86},[55,56],{"lat":56,"lon":55},{"facility":89,"status":18,"city":51,"state":18,"zip":90,"country":32,"countryCode":33,"cosmosGeoPoint":91,"geoPoint":93,"contacts":18},"St George's University Hospitals NHS Foundation Trust","SW17 0QT",{"type":35,"coordinates":92},[55,56],{"lat":56,"lon":55},{"facility":95,"status":18,"city":96,"state":18,"zip":97,"country":32,"countryCode":33,"cosmosGeoPoint":98,"geoPoint":102,"contacts":18},"Manchester University NHS Foundation Trust","Manchester","M13 9WL",{"type":35,"coordinates":99},[100,101],-2.23743,53.48095,{"lat":101,"lon":100},{"facility":104,"status":18,"city":105,"state":18,"zip":106,"country":32,"countryCode":33,"cosmosGeoPoint":107,"geoPoint":111,"contacts":18},"Oxford University Hospitals NHS Foundation Trust","Oxford","OX6 2GG",{"type":35,"coordinates":108},[109,110],-1.25596,51.75222,{"lat":110,"lon":109},{"facility":113,"status":18,"city":114,"state":18,"zip":115,"country":32,"countryCode":33,"cosmosGeoPoint":116,"geoPoint":120,"contacts":18},"The Royal Berkshire NHS Foundation Trust","Reading","RG1 5AN",{"type":35,"coordinates":117},[118,119],-0.97113,51.45625,{"lat":119,"lon":118},{"facility":122,"status":18,"city":123,"state":18,"zip":124,"country":32,"countryCode":33,"cosmosGeoPoint":125,"geoPoint":129,"contacts":18},"The Royal Wolverhampton NHS Trust","Wolverhampton","WV10 0QP",{"type":35,"coordinates":126},[127,128],-2.12296,52.58547,{"lat":128,"lon":127},{"type":131,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[133,135,137,139,141,143,145],{"name":134,"class":6},"King's College London",{"name":136,"class":6},"Oxford University Hospitals NHS Trust",{"name":138,"class":6},"University of Southampton",{"name":140,"class":6},"University of Birmingham",{"name":142,"class":6},"Barts & The London NHS Trust",{"name":144,"class":6},"City, University of London",{"name":146,"class":147},"National Institute for Health Research, United Kingdom","OTHER_GOV","100311417","blood-pressure-monitoring-in-high-risk-pregnancy-to-improve-the-detection-and-monitoring-of-hypertension-100311417",false,"NCT03334149","Blood Pressure Monitoring in High Risk Pregnancy to Improve the Detection and Monitoring of Hypertension","BUMP","BUMP 1\n\nInclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the trial\n* Pregnant woman, aged 18 years or above between 16+0 to 24+0 weeks\n* Able and willing to comply with trial requirements\n* Willing to allow her general practitioner and consultant, if appropriate, to be notified of participation in the trial\n* At higher risk for hypertension in pregnancy \u002F pre-eclampsia defined as one or more of the following risk factors:\n* Age 40 years or older\n* Nulliparity\n* Pregnancy interval of more than 10 years\n* Family history of pre-eclampsia\n* Previous history of pre-eclampsia or gestational hypertension\n* Body mass index 30 kg\u002Fm2 or above at booking\n* Chronic kidney disease\n* Twin pregnancy\n* Diabetes (Type 1\\&2)\n* Autoimmune Disease (eg systemic lupus erythematosis or antiphospholipid disease)\n\nExclusion Criteria:\n\n* Chronic Hypertension\n\nBUMP 2:\n\nInclusion Criteria:\n\n• Women developing pregnancy hypertension previously randomised in BUMP 1 (regardless of gestation).\n\nOR\n\n* Women with chronic hypertension (defined as sustained systolic BP≥140 mmHg and\u002For diastolic BP≥90 mmHg, present at booking or before 20 weeks' gestation, or receiving treatment outside pregnancy and\u002For at time of referral).\n* Recruited up to 37+0 weeks' gestation.\n\nOR\n\n* Women with hypertension after 20 weeks' gestation (defined as sustained systolic BP≥140 mmHg and\u002For diastolic BP≥90 mmHg).\n* Recruited at 20+0 to 37+0 weeks' gestation.\n\nAND\n\n* Participant is willing and able to give informed consent for participation in the trial.\n* Woman aged 18 years or above.\n* Willing to allow her general practitioner and consultant, if appropriate, to be notified of participation in the trial.\n\nExclusion criteria:\n\nAnticipated inpatient admission considered likely to lead to imminent delivery (within the next 48 hours)",true,"FEMALE","18 Years",{"count":159,"type":160},3042,"ACTUAL","INTERVENTIONAL",[163],"NA","Raised blood pressure is a common problem in pregnancy. Raised blood pressure and pre-eclampsia affect about one in ten women and are a major cause of death and premature birth in the United Kingdom and worldwide.\n\nMany women have expressed an interest in monitoring their own blood pressure in between antenatal visits but there has been very little research to guide this. The investigators would like to know if the diagnosis and subsequent care of women with raised blood pressure can be improved if women were able to monitor their own blood pressure safely at home. This work will test whether optimising the diagnosis, monitoring and management of raised BP during pregnancy through self-monitoring of BP is effective, acceptable and cost-effective compared to usual care.\n\nThe research team have being working with pregnant women, doctors and midwives to develop a simple and accurate method of self-monitoring of blood pressure in pregnancy.\n\nThis randomised controlled trial will:\n\n1. Compare self-monitoring with usual care in women at higher risk of hypertension in pregnancy and assess if self-monitoring can identify raised blood pressure earlier.\n2. Compare self-monitoring with usual care for women with high blood pressure in pregnancy to see if it leads to lower blood pressure.\n3. Assess if self-monitoring is cost-effective.\n\nPregnant women who chose to take part in these studies will be randomised to either usual care or asked to monitor their own blood pressure during their pregnancy in addition to their usual antenatal care.",[166,167,168,169],"Pregnancy, High Risk","Pre-Eclampsia","Hypertension","Hypertension, Pregnancy-Induced","COMPLETED","2022-06-01",{"date":173,"type":160},"2022-06-06",{"date":175,"type":160},"2017-11-22",{"date":177,"type":160},"2020-09-16",{"name":5,"class":6},13]