Shoulder Dystocia
Conditions
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).
Interventions
OTHERRemote 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.
OTHERCognitive 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.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total performance score | 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
| Measure | Time frame | Description |
|---|---|---|
| Cognitive load (NASA-TLX) | Immediately after the simulated scenario | NASA Task Load Index (0-20 points across 6 subcategories; higher scores indicate higher cognitive load). |
| Usability (System Usability Scale, SUS) | Immediately after the simulated scenario | Usability of the randomized support tool measured on the System Usability Scale (10 items, 1-5 points each). |
| Subjective experience (Likert) | 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). |
| Communication quality (Likert) | 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) |
Countries
Austria
Contacts
CONTACTMathias Maleczek, MD
CONTACTBernhard Rössler, MD
Outcome results
None listed