An interventional study of Remote Tele-Support and Cognitive Aid in Shoulder Dystocia, sponsored by Medical University of Vienna. Not yet recruiting at 1 site in Austria. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Health services research
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.
This 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.
Teams 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).
Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.
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Exclusion:
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.
Other: Cognitive Aid
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.
Other: 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.
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.
Total performance score
Total performance score for the management of the standardized shoulder dystocia scenario (range 0-25 points; higher scores indicate better performance).
Time frame: At completion of the simulated shoulder dystocia scenario
Cognitive load (NASA-TLX)
NASA Task Load Index (0-20 points across 6 subcategories; higher scores indicate higher cognitive load).
Time frame: Immediately after the simulated scenario
Usability (System Usability Scale, SUS)
Usability of the randomized support tool measured on the System Usability Scale (10 items, 1-5 points each).
Time frame: Immediately after the simulated scenario
Subjective experience (Likert)
Participants' subjective experience assessed using a 5-point Likert scale (range 1-5; higher scores indicate greater confidence in the shoulder dystocia algorithm and better perceived overall performance in the simulation).
Time frame: Immediately after the simulated scenario
Communication quality (Likert)
Quality of communication of the tele-support on a 5-point Likert scale, reported by the participant as well as by the expert.(range 1-5; higher scores indicate better quality of communication)
Time frame: Immediately after the simulated scenario
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Dec 2026, 3 months later.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Shoulder Dystocia
Medical University of Vienna →