[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652392":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":38,"responsibleParty":53,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":25,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":25,"overallStatus":77,"whyStopped":25,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: Cognitive Aid","ACTIVE_COMPARATOR","Teams manage the standardized shoulder dystocia scenario supported by a standardized visual cognitive aid (written instructions and pictograms of the required external and internal maneuvers). No additional clinical assistance is provided after scenario initiation.",[13],"Other: Cognitive Aid",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B: Remote Tele-Support","EXPERIMENTAL","Teams manage the standardized shoulder dystocia scenario supported by live real-time video guidance from a credentialed obstetric expert via a study-issued mobile device using Signal.",[19],"Other: Remote Tele-Support",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Remote Tele-Support","Live real-time video guidance provided by a credentialed obstetric expert (midwife or obstetrician) via a study-issued mobile device using Signal (GDPR-compliant secure video call) throughout the standardized shoulder dystocia scenario.",[15],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Cognitive Aid","A standardized visual reference tool provided at the start of the scenario, containing concise written instructions and pictograms illustrating the three required external maneuvers and the single internal maneuver. No additional clinical assistance is provided after scenario initiation.",[9],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Mathias Maleczek, MD","CONTACT","+4314040041020","mathias.maleczek@meduniwien.ac.at",{"name":37,"role":33,"phone":25,"phoneExt":25,"email":25},"Bernhard Rössler, MD",[39],{"facility":5,"status":25,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Vienna","State of Vienna","1090","Austria","AT",{"type":46,"coordinates":47},"Point",[48,49],16.37208,48.20849,{"lat":49,"lon":48},[52],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Mathias Maleczek","Principal Investigator","100652392","telesdystocia-tele-support-vs-cognitive-aid-in-simulated-shoulder-dystocia-100652392",false,"NCT07772102","TelesDystocia: Tele-Support vs. Cognitive Aid in Simulated Shoulder Dystocia","TelesDystocia: A Randomized Controlled Simulation Trial Comparing Remote Tele-Support Versus a Standard Cognitive Aid for the Management of Shoulder Dystocia","TelesDystocia","Inclusion:\n\n* Adult healthy healthcare providers (paramedics, emergency physicians, midwives, nurses)\n* Working in teams of at least two persons\n* Fluent in German (the cognitive aid is provided in German)\n\nExclusion:\n\n* Training in shoulder dystocia management (McRoberts, suprapubic pressure, Gaskin) in the preceding six months\n* Not fluent in German",true,"ALL","18 Years",{"count":69,"type":70},52,"ESTIMATED","INTERVENTIONAL",[73],"NA","Shoulder dystocia is an unpredictable, time-critical obstetric emergency requiring immediate recognition and rapid execution of established maneuvers. To date, there is no published evidence evaluating remote real-time support for the management of shoulder dystocia, which could be especially relevant for providers not frequently confronted with obstetric emergencies.\n\nThis prospective, randomized, controlled, simulation-based trial compares healthcare providers' performance in managing a standardized shoulder dystocia scenario when supported by remote tele-assistance versus a standard cognitive aid. Teams of at least two healthcare providers manage a standardized scenario on the Laerdal MamaBirthie Task Trainer, with a trained study team member playing the laboring patient. Successful delivery requires completion of three predefined external maneuvers and one internal maneuver.\n\nTeams are randomized to Group A (cognitive aid: a standardized visual reference tool with written instructions and pictograms) or Group B (remote tele-support: live video guidance from a credentialed obstetric expert via Signal). The primary outcome is the total performance score (0-25 points). Secondary outcomes include cognitive load (NASA-TLX), usability (System Usability Scale), and subjective experience and communication quality (5-point Likert scales).",[76],"Shoulder Dystocia","NOT_YET_RECRUITING","2026-08-17",{"date":80,"type":81},"2026-08-19","ACTUAL",{"date":83,"type":70},"2026-08-25",{"date":85,"type":70},"2027-01-30",{"name":5,"class":6},1]