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

NCT07772102 | Not Yet Recruiting

• 1 other identifier: TelesDystocia_1
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Shoulder Dystocia

Outcome Measures

Primary Outcomes (1)

• Total performance score

  Total performance score for the management of the standardized shoulder dystocia scenario (range 0-25 points; higher scores indicate better performance).

  At completion of the simulated shoulder dystocia scenario

Secondary Outcomes (4)

• Cognitive load (NASA-TLX)

  Immediately after the simulated scenario

• Usability (System Usability Scale, SUS)

  Immediately after the simulated scenario

• Subjective experience (Likert)

  Immediately after the simulated scenario

• Communication quality (Likert)

  Immediately after the simulated scenario

Study Arms (2)

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.

Other: Cognitive Aid

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.

Other: Remote Tele-Support

Interventions

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.

Group B: Remote Tele-Support

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.

Group A: Cognitive Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Shoulder Dystocia

Condition Hierarchy (Ancestors)

Dystocia; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Mathias Maleczek, MD

CONTACT

+4314040041020; mathias.maleczek@meduniwien.ac.at

Bernhard Rössler, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 19, 2026
• Study Start: August 25, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)