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NCT Number: NCT07772102

TelesDystocia: Tele-Support vs. Cognitive Aid in Simulated Shoulder Dystocia

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • Adult healthy healthcare providers (paramedics, emergency physicians, midwives, nurses)
  • Working in teams of at least two persons
  • Fluent in German (the cognitive aid is provided in German)

Exclusion:

  • Training in shoulder dystocia management (McRoberts, suprapubic pressure, Gaskin) in the preceding six months
  • Not fluent in German

Treatment and study plan

Remote Tele-Support

Other

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.

Cognitive Aid

Other

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.

Primary outcomes

  1. Total performance score

    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).

Secondary outcomes

  1. Cognitive load (NASA-TLX)

    Time frame: Immediately after the simulated scenario

    NASA Task Load Index (0-20 points across 6 subcategories; higher scores indicate higher cognitive load).

  2. Usability (System Usability Scale, SUS)

    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).

  3. Subjective experience (Likert)

    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).

  4. Communication quality (Likert)

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Bernhard Rössler, MD

CONTACT

Mathias Maleczek, MD

CONTACT

[email protected]

+4314040041020

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

TelesDystocia: A Randomized Controlled Simulation Trial Comparing Remote Tele-Support Versus a Standard Cognitive Aid for the Management of Shoulder Dystocia

Acronym: TelesDystocia

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

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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