Medical University of Vienna
Vienna, State of Vienna, 1090, Austria
NCT Number: NCT07772102
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).
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Vienna, State of Vienna, 1090, Austria
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion:
Exclusion:
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.
Time frame: At completion of the simulated shoulder dystocia scenario
Total performance score for the management of the standardized shoulder dystocia scenario (range 0-25 points; higher scores indicate better performance).
Time frame: Immediately after the simulated scenario
NASA Task Load Index (0-20 points across 6 subcategories; higher scores indicate higher cognitive load).
Time frame: Immediately after the simulated scenario
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
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
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)
Contact information is provided by the study sponsor or research team.
Medical University of Vienna
Other
TelesDystocia: A Randomized Controlled Simulation Trial Comparing Remote Tele-Support Versus a Standard Cognitive Aid for the Management of Shoulder Dystocia
Acronym: TelesDystocia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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