[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659798":3},{"organization":4,"outcomesModule":7,"designInfo":98,"detailedDescription":103,"studyPopulation":103,"armGroups":107,"interventions":120,"overallOfficials":131,"centralContacts":143,"locations":151,"responsibleParty":262,"collaborators":265,"id":277,"slug":278,"hasResults":279,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":279,"sex":285,"minAge":286,"maxAge":103,"enrollmentInfo":287,"targetDuration":103,"studyType":290,"phases":291,"briefSummary":293,"conditions":294,"keywords":296,"overallStatus":302,"whyStopped":103,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":312},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":70},[9],{"measure":10,"description":11,"timeFrame":12},"Complete abortion","Effectiveness of 'no-test' tele-abortion, measured in the proportion of complete abortion with no ongoing pregnancy or surgical intervention for incomplete abortion, within 42 days of the medical abortion (mifepristone intake).","42 days following mifepristone intake",[14,17,20,23,25,27,29,33,36,39,42,45,48,51,54,58,61,63,65,67],{"measure":15,"description":16,"timeFrame":12},"Additional abortion treatment","Any additional treatment the participant has received to complete the abortion including medical (misoprostol or mifepristone and misoprostol) or surgical (uterine aspiration) treatment",{"measure":18,"description":19,"timeFrame":12},"Rates of complications","Rates of complications: incomplete abortion, ongoing pregnancy, surgical intervention, infection requiring treatment, ectopic pregnancy not requiring surgery (Adverse Events) and hospitalisation ≥24 hours, blood transfusion, ectopic pregnancy requiring surgery, deaths (Serious Adverse Events).",{"measure":21,"description":22,"timeFrame":12},"Ectopic pregnancy","Ectopic pregnancy: time to diagnosis from study inclusion (days,hours)",{"measure":21,"description":24,"timeFrame":12},"Ectopic pregnancy: complication such as rupture (yes\u002Fno)",{"measure":21,"description":26,"timeFrame":12},"Ectopic pregnancy: S-hcg level at diagnosis",{"measure":21,"description":28,"timeFrame":12},"Ectopic pregnancy: treatment (expectant management, medical treatment, surgical treatment)",{"measure":30,"description":31,"timeFrame":32},"Gestational age at treatment","Gestational length at time of initiating treatment (mifepristone intake). Measured in weeks and days (by dates for the Last Menstrual Period (LMP) and ultrasound when available). LMP collected at baseline, date of mifepristone collected at the follow-up survey. Ultrasound dating collected from the endline review of medical records.","LMP collected at baseline. Date of mifepristone collected at the follow-up survey. Ultrasound dating collected from the endline review of medical records (42 days following abortion (mifepristone intake).",{"measure":34,"description":35,"timeFrame":12},"Underestimation of gestational age","Proportion of underestimation (\\>10+0 weeks) of gestational age detected on ultrasound (LMP at baseline vs ultrasound findings).",{"measure":37,"description":38,"timeFrame":12},"Severe pain","Pain defined as Numeric Rating Scale (NRS) \\>7",{"measure":40,"description":41,"timeFrame":12},"Bleeding days","Number of days bleeding (requiring a pad or similar)",{"measure":43,"description":44,"timeFrame":12},"Bleeding amount","Bleeding in relation to menstruation (more\u002Fsimilar or less than a normal menstruation) measured at the follow-up survey.",{"measure":46,"description":47,"timeFrame":12},"Access: time to accessing treatment","Time to accessing treatment (from inclusion in the study to the pick-up visit\u002Fin-clinic visit; days).",{"measure":49,"description":50,"timeFrame":12},"Access: Travel time to access treatment","Travel time to access abortion medications. Measured in hours and minutes",{"measure":52,"description":53,"timeFrame":12},"Access: Time to initiating treatment","Time to initiating treatment (from inclusion in the study to mifepristone intake; days)",{"measure":55,"description":56,"timeFrame":57},"Postabortion contraceptive use","Measured in use at follow-up categorised as Long-Acting Reversible Contraception (LARC), Short Acting Reversible Contraception (SARC), barrier methods, natural family planning methods (NPF), sterilization and emergency contraception","42 days of the medical abortion (mifepristone intake)",{"measure":59,"description":60,"timeFrame":57},"Satisfaction with care","Short Assessment of Patient Satisfaction Scale (SAPS). The SAPS scale contains 7 questions with 5 response options scored 0-4: very satisfied; satisfied; neither satisfied nor dissatisfied; dissatisfied; very dissatisfied. The questions assess satisfaction with:\n\n1. the effectiveness of treatment\n2. information provision\n3. technical skills of the healthcare provider\n4. involvement in decision-making\n5. the patient-provider interaction\n6. time with the healthcare provider\n7. overall, with the care received",{"measure":59,"description":62,"timeFrame":12},"Overall satisfaction with care using a likert scale",{"measure":59,"description":64,"timeFrame":12},"Whether the participant would choose the same model of care again in case of wanting another abortion in the future",{"measure":59,"description":66,"timeFrame":12},"Whether the participant would recommend the model of care received to a friend",{"measure":68,"description":69,"timeFrame":12},"Satisfaction with information","Satisfaction with information sources using a likert scale (5 options)",[71,74,77,81,84,88,91,95],{"measure":72,"description":73,"timeFrame":12},"Testing","Testing done in-clinic; yes\u002Fno; type of tests (ultrasound\u002Fpelvic exam\u002Fblood-hCG\u002Furine-hCG\u002FSTI-testing) and timing (before or after treatment)",{"measure":75,"description":76,"timeFrame":12},"Additional contacts","Number of contacts defined as all contacts: (number of contacts; type of contacts (in-clinic\u002Fremote), timing of contacts (before\u002Fafter treatment) and location (emergency gynaecological department; abortion clinic",{"measure":78,"description":79,"timeFrame":80},"Access: Distance to abortion clinic","Distance to nearest abortion clinic with emergency care. Calculated using participants postal code and nearest abortion clinic (km)","At baseline (postal code) and 42 days following mifepristone intake (abortion clinic)",{"measure":82,"description":83,"timeFrame":12},"Access: Travel time","Travel time to access medications (hours and minutes)",{"measure":85,"description":86,"timeFrame":87},"Main mode of transport","Main mode of transport (public transport\u002Fcar\u002Fbike\u002Fwalking)","42 days following mifepristone uptake",{"measure":89,"description":90,"timeFrame":12},"Productivity loss","Time off from work as a result of the abortion including attending visits and contacts with healthcare providers, undergoing the abortion.",{"measure":92,"description":93,"timeFrame":94},"Quality of Life","Quality of Life will be assessed using the EQ-5D scale. Conversion of scores to Quality-Adjusted Life Years (QALYs)","At baselina and 42 days following mifepristone intake",{"measure":96,"description":97,"timeFrame":12},"Information sources","Main information sources used to obtain information about 1) the abortion process and 2) postabortion contraception",{"allocation":99,"interventionModel":100,"interventionModelDescription":101,"primaryPurpose":102,"observationalModel":103,"timePerspective":103,"maskingInfo":104},"RANDOMIZED","PARALLEL","Multicenter randomized controlled non-inferiority open trial","TREATMENT",null,{"masking":105,"maskingDescription":106,"whoMasked":103},"NONE","Statistician",[108,114],{"label":109,"type":110,"description":111,"interventionNames":112},"No-test tele-abortion","EXPERIMENTAL","'No-test' tele-abortion (intervention arm)",[113],"Other: no-test medical abortion",{"label":115,"type":116,"description":117,"interventionNames":118},"Standard care medical abortion","ACTIVE_COMPARATOR","Standard care (control arm)",[119],"Other: Standard Care (in control arm)",[121,127],{"type":6,"name":122,"description":123,"armGroupLabels":124,"otherNames":125},"no-test medical abortion","'No-test' tele-abortion i.e., medical abortion delivered via telecommunications (phone and web-based) and the medical abortion self-managed at home. Prior in clinic-visit with routine testing (ultrasound, pelvic exam) is omitted and the eligibility assessment is history-based. To meet current legal requirements, mifepristone is taken during a brief in-clinic pick-up visit of a medical abortion kit.",[109],[126],"teleabortion",{"type":6,"name":128,"description":129,"armGroupLabels":130,"otherNames":103},"Standard Care (in control arm)","Standard care defined as in-clinic provision of medical abortion, delivered during one in-clinic consultation with routine testing (ultrasound, pelvic exam), information provision and mifepristone-intake, followed by misoprostol intake at home.",[115],[132,135,137,139,141],{"name":133,"affiliation":5,"role":134},"Amanda Cleeve, PhD, MSc, RNM","STUDY_CHAIR",{"name":133,"affiliation":5,"role":136},"PRINCIPAL_INVESTIGATOR",{"name":138,"affiliation":5,"role":136},"Karin Brandell, PhD, MD",{"name":140,"affiliation":5,"role":136},"Kristina Gemzell Danielsson, PhD, MD",{"name":142,"affiliation":5,"role":136},"Margit Endler, PhD, MD",[144,148],{"name":133,"role":145,"phone":146,"phoneExt":103,"email":147},"CONTACT","+46737750911","Amanda.cleeve@ki.se",{"name":138,"role":145,"phone":149,"phoneExt":103,"email":150},"0769011171","karin.brandell@ki.se",[152,167,179,191,201,213,223,233,243,252],{"facility":153,"status":103,"city":154,"state":103,"zip":103,"country":155,"countryCode":156,"cosmosGeoPoint":157,"geoPoint":162,"contacts":163},"Gällivare sjukhus","Gällivare","Sweden","SE",{"type":158,"coordinates":159},"Point",[160,161],20.65278,67.13387,{"lat":161,"lon":160},[164],{"name":165,"role":145,"phone":103,"phoneExt":103,"email":166},"Helena Carré, PhD, MD","helena.carre@norrbotten.se",{"facility":168,"status":103,"city":169,"state":103,"zip":103,"country":155,"countryCode":156,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Karlskoga lasarett","Karlskoga",{"type":158,"coordinates":171},[172,173],14.52386,59.32667,{"lat":173,"lon":172},[176],{"name":177,"role":145,"phone":103,"phoneExt":103,"email":178},"Jan Brynhildsen, PhD, MD","jan.brynhildsen@oru.se",{"facility":180,"status":103,"city":181,"state":103,"zip":103,"country":155,"countryCode":156,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Lycksele Lasarett","Lycksele",{"type":158,"coordinates":183},[184,185],18.67351,64.59537,{"lat":185,"lon":184},[188],{"name":189,"role":145,"phone":103,"phoneExt":103,"email":190},"Ulrika Ottander, PhD, MD","ulrika.ottander@umu.se",{"facility":192,"status":103,"city":193,"state":103,"zip":103,"country":155,"countryCode":156,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Örebro University Hospital","Örebro",{"type":158,"coordinates":195},[196,197],15.2066,59.27412,{"lat":197,"lon":196},[200],{"name":177,"role":145,"phone":103,"phoneExt":103,"email":178},{"facility":202,"status":103,"city":203,"state":103,"zip":103,"country":155,"countryCode":156,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Östersunds sjukhus","Östersund",{"type":158,"coordinates":205},[206,207],14.63566,63.1792,{"lat":207,"lon":206},[210],{"name":211,"role":145,"phone":103,"phoneExt":103,"email":212},"Malin Huber, PhD, MD","malin.huber@umu.se",{"facility":214,"status":103,"city":215,"state":103,"zip":103,"country":155,"countryCode":156,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Skellefteå sjukhus","Skellefteå",{"type":158,"coordinates":217},[218,219],20.95279,64.75067,{"lat":219,"lon":218},[222],{"name":189,"role":145,"phone":103,"phoneExt":103,"email":190},{"facility":224,"status":103,"city":225,"state":103,"zip":103,"country":155,"countryCode":156,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"Sunderby Sjukhus","Södra Sunderbyn",{"type":158,"coordinates":227},[228,229],21.94004,65.65983,{"lat":229,"lon":228},[232],{"name":165,"role":145,"phone":103,"phoneExt":103,"email":166},{"facility":234,"status":103,"city":235,"state":103,"zip":103,"country":155,"countryCode":156,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"Karolinska University Hospital","Stockholm",{"type":158,"coordinates":237},[238,239],18.06871,59.32938,{"lat":239,"lon":238},[242],{"name":138,"role":145,"phone":103,"phoneExt":103,"email":150},{"facility":244,"status":103,"city":235,"state":103,"zip":103,"country":155,"countryCode":156,"cosmosGeoPoint":245,"geoPoint":247,"contacts":248},"Södersjukhuset",{"type":158,"coordinates":246},[238,239],{"lat":239,"lon":238},[249],{"name":250,"role":145,"phone":103,"phoneExt":103,"email":251},"Gustaf Rejnö, PhD, MD","gustaf.rejno@regionstockholm.se",{"facility":253,"status":103,"city":254,"state":103,"zip":103,"country":155,"countryCode":156,"cosmosGeoPoint":255,"geoPoint":259,"contacts":260},"Norrlands Universitetssjukhus","Umeå",{"type":158,"coordinates":256},[257,258],20.25972,63.82842,{"lat":258,"lon":257},[261],{"name":189,"role":145,"phone":103,"phoneExt":103,"email":190},{"type":136,"investigatorFullName":263,"investigatorTitle":264,"investigatorAffiliation":5,"oldNameTitle":103,"oldOrganization":103},"Amanda Cleeve","Associate prof, PhD, MSc, RNM",[266,269,271,273,275],{"name":267,"class":268},"Region Stockholm","OTHER_GOV",{"name":270,"class":6},"Region Jämtland Härjedalen",{"name":272,"class":268},"Region Västerbotten",{"name":274,"class":6},"Region Norrbotten",{"name":276,"class":6},"Region Örebro County","100659798","no-test-tele-abortion-a-multi-centre-randomised-controlled-trial-100659798",false,"NCT07868991","'No-test' Tele-abortion: a Multi-centre Randomised Controlled Trial","Optimising Healthcare Access Through 'No-Test' Tele-Abortion: a Multi-centre Randomised Controlled Trial in Sweden (OPTIMISE)","OPTIMISE","Inclusion Criteria:\n\n1. Pregnant less than or equal to 10+0 weeks according to date for the LMP\n2. Age ≥18 years\n3. Wiling to perform MA at home\n4. Regular menses prior to this pregnancy\n5. Willing to undergo an abortion without prior clinical examinations (gynaecological examination and ultrasound)\n6. Willing and able to receive information remotely\n7. Willing and able to provide electronic informed consent\n\nExclusion Criteria:\n\n1. Contraindications to MA (known allergy to mifepristone or misoprostol)\n2. Health condition requiring in-clinic abortion\n3. Uncertainty around the dates for LMP,\n4. Hormonal contraception used \\\u003C 3 months\n5. Risk factors for ectopic pregnancy (previous ectopic pregnancy, previous tubal surgery or tubal ligation, use of intrauterine contraception at conception, signs of pelvic inflammatory disease)\n6. Symptoms of pathologic pregnancy (bleeding and\u002For pain)\n7. No proficiency in Swedish or English","FEMALE","18 Years",{"count":288,"type":289},978,"ESTIMATED","INTERVENTIONAL",[292],"NA","Brief Summary The goal of this clinical trial is to learn whether a no-test telemedicine medical abortion model can provide abortion care that is as effective and safe as standard clinic-based medical abortion care among women aged 18 years and older with an early pregnancy who wish to have a medical abortion at home.\n\nThe main questions it aims to answer are:\n\n* Is no-test telemedicine medical abortion (without routine ultrasound) as effective as standard clinic-based medical abortion (with routine ultrasound) in achieving complete abortion?\n* Is no-test telemedicine medical abortion as safe, acceptable, and cost-effective as standard clinic-based medical abortion? Researchers will compare no-test telemedicine medical abortion to standard clinic-based medical abortion to determine whether the telemedicine model results in similar effectiveness and safety outcomes while improving access to care.\n\nParticipants will:\n\n* Be randomly assigned to receive either no-test telemedicine medical abortion or standard clinic-based medical abortion.\n* Receive counseling and clinical assessment according to their assigned care model.\n* Use medical abortion treatment at home.\n* Complete follow-up assessments approximately 6 weeks after the abortion.\n* Provide information about treatment outcomes, complications, healthcare contacts, satisfaction with care, and contraceptive use.\n\nThis study will enroll 978 women across five healthcare regions in Sweden. The results will inform future evidence-based guidelines for medical abortion care and may improve access to abortion services, particularly for individuals living in rural and underserved areas.",[295],"Medical Abortion",[297,298,299,300,301],"No-test abortion","tele-abortion","telemedicin","medical abortion","randomised controlled trial","NOT_YET_RECRUITING","2026-10-08",{"date":305,"type":306},"2026-10-09","ACTUAL",{"date":308,"type":289},"2026-12",{"date":310,"type":289},"2029-01",{"name":5,"class":6},10]