[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633582":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":60,"collaborators":18,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":18,"enrollmentInfo":73,"targetDuration":18,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":43,"whyStopped":18,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Institut Investigacio Sanitaria Pere Virgili","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Primiparous women undergoing HIFEM technology treatment (BTL Emsella)","EXPERIMENTAL","Participants meeting the inclusion criteria upon evaluation who consent to the use of Emsella HIFEM technology.",[13],"Device: HIFEM (HIGH INTENSITY FOCUSED ELECTROMAGNETIC) BTL EMSELLA",{"label":15,"type":16,"description":17,"interventionNames":18},"First-time mothers in the non-treatment group","NO_INTERVENTION","Participants meeting the inclusion criteria at baseline who opt out of the treatment. These individuals will undergo a follow-up evaluation after 3 months",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","HIFEM (HIGH INTENSITY FOCUSED ELECTROMAGNETIC) BTL EMSELLA","Eight sessions twice weekly, with a two-week gap between the first and second blocks of four sessions",[9],[26],{"name":27,"affiliation":28,"role":29},"LYS GARCIA VILAPLANA, MIDWIFE. PHD STUDENT","UNIVERSITAT ROVIRA I VIRGILI. PROCREAR MEDICAL CENTER","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"LYS GARCIA VILAPLANA, Lead Researcher","CONTACT","+34619357158","lys@procrear.es",{"name":37,"role":33,"phone":38,"phoneExt":18,"email":39},"CRISTINA REY REÑONES, DOCTORA","+34686853715","cristina.rey@urv.cat",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Centro Procrear","RECRUITING","Tarragona","TARRAGONA","43002","Spain","ES",{"type":50,"coordinates":51},"Point",[52,53],1.24544,41.11905,{"lat":53,"lon":52},[56,58],{"name":57,"role":33,"phone":34,"phoneExt":18,"email":35},"LYS GARCIA VILAPLANA",{"name":59,"role":33,"phone":18,"phoneExt":18,"email":18},"CRISTINA REY",{"type":29,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Lys Garcia Vilaplana","MIDWIFE","100633582","hifem-in-pospartum-high-intensity-focused-electro-magnetic-technology-100633582",false,"NCT07528560","HIFEM in Pospartum (High Intensity Focused Electro-Magnetic Technology)","Effectiveness of HIFEM (High Intensity Focused Electro-Magnetic Technology) for Improving Pelvic Floor Muscle Tone in Postpartum Women: Study Protocol.","HIFEM","Inclusion Criteria:\n\n* Primiparous women\n* Vaginal delivery.\n* Single-fetus pregnancy \u002F Singleton pregnancy.\n* Full-term pregnancy (\\> 37 weeks of gestation).\n* Asymptomatic: No symptoms associated with pelvic floor muscle weakening, such as any type of incontinence or presence of prolapse.\n* Post-quarantine period: Between 6 and 12 weeks postpartum\n\nExclusion Criteria:\n\n* Implanted devices: Such as pacemakers, defibrillators, or neurostimulators.\n* Electronic implants.\n* Drug delivery pumps (e.g., insulin pumps or medication infusion pumps).\n* Metallic implants.\n* Intrauterine devices (IUDs) containing any type of metal.\n* Application over the growth plate area.\n* Severe or life-threatening disorders.\n* Pulmonary insufficiency.\n* Cardiac disorders \u002F Heart conditions.\n* Decompensated hemorrhagic conditions.\n* Decompensated blood coagulation disorders.\n* Malignant tumors \u002F Malignancy.\n* Fever.\n* Epilepsy.\n* Menstruation\n* Pregnant","FEMALE","18 Years",{"count":74,"type":75},60,"ESTIMATED","INTERVENTIONAL",[78],"NA","The goal of this non-randomized community clinical trial is to test how effective HIFEM (High Intensity Focused Electromagnetic) technology (BTL Emsella) is in strengthening pelvic floor muscles. The study focuses on first-time mothers who have recently given birth (postpartum) via vaginal delivery and are not showing symptoms of dysfunction.\n\nThe main question this study aims to answer is:\n\n\\- Can pelvic floor strength be restored after being exposed to weakening risk factors like pregnancy and childbirth?\n\nHow to study works; The researcher will compare two groups of women to see how their muscles recover:\n\n1. Those who receive the Emsella HIFEM treatment.\n2. Those who follow their natural recovery without the treatment.\n\nParticipant Journey:\n\n* Initial Check-up: Once the standard 6-week postpartum recovery period (quarantine) is over.\n* Eligibility: The researcher checks if participants meet the study criteria.\n* Decision: After receiving full information and signing a consent form, participants decide whether or not to undergo the treatment.\n* Final Results: A follow-up assessment is conducted 3 months after the first visit, regardless of whether the treatment was used.",[81],"Pelvic Floor Muscle Dysfunction",[83,84,85,86,87,88,89,90,91,92,93,94,95,96],"Puborectalis muscle","pelvic floor","transperineal ultrasound","posapartum","Electromagnetic therapy","female","incontinence","perineum","delivery","strain","ultrasonography","cesarean section","electroestimulation","pregnancy","2026-04-07",{"date":99,"type":100},"2026-04-14","ACTUAL",{"date":102,"type":75},"2026-04",{"date":104,"type":75},"2026-12",{"name":5,"class":6},1]