Shoulder DystociaTelesDystociaNCT07772102
TelesDystocia: Tele-Support vs. Cognitive Aid in Simulated Shoulder Dystocia
A study testing Remote Tele-Support and Cognitive Aid in people with Shoulder Dystocia, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Dystocia
- What is being tested?
- Remote Tele-Support and Cognitive Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteAustria
- Study dates
- 25 Aug 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Training in shoulder dystocia management (McRoberts, suprapubic pressure, Gaskin) in the preceding six months
- Not fluent in German
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bernhard Rössler, MD contact
Austria1 site
Medical University of Vienna
Vienna, State of Vienna, 1090
Mathias Maleczek, MD, +4314040041020, mathias.maleczek@meduniwien.ac.at
About this study
Official title: TelesDystocia: A Randomized Controlled Simulation Trial Comparing Remote Tele-Support Versus a Standard Cognitive Aid for the Management of 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).
- Conditions
- Shoulder Dystocia
- Being tested
- Remote Tele-Support, Cognitive Aid
- Medical subject headings
- Shoulder Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Tele-SupportOther
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 AidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Remote Tele-Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total performance score
Total performance score for the management of the standardized shoulder dystocia scenario (range 0-25 points; higher scores indicate better performance).
Measured: At completion of the simulated shoulder dystocia scenario
Secondary outcomes (4)
Cognitive load (NASA-TLX)
NASA Task Load Index (0-20 points across 6 subcategories; higher scores indicate higher cognitive load).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: Immediately after the simulated scenario
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start25 Aug 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder DystociaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathias Maleczek, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772102
- Sponsor's protocol ID
- TelesDystocia_1
- Acronym
- TelesDystocia
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TelesDystocia: A Randomized Controlled Simulation Trial Comparing Remote Tele-Support Versus a Standard Cognitive Aid for the Management of Shoulder Dystocia
- ClinicalTrials.gov ID
- NCT07772102
- Acronym / sponsor ID
- TelesDystocia / TelesDystocia_1
- Conditions
- Shoulder Dystocia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 25 Aug 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Cognitive Aid | Active comparator | Other: Cognitive AidTeams 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. |
| Group B: Remote Tele-Support | Experimental | Other: Remote Tele-SupportTeams 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Training in shoulder dystocia management (McRoberts, suprapubic pressure, Gaskin) in the preceding six months
- Not fluent in German
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Tele-SupportLive 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. | Other | Group B: Remote Tele-Support |
| Cognitive AidA 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. | Other | Group A: Cognitive Aid |
Primary outcome
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).
4 secondary outcomes
Cognitive load (NASA-TLX)
Time frame: Immediately after the simulated scenario
Usability (System Usability Scale, SUS)
Time frame: Immediately after the simulated scenario
Subjective experience (Likert)
Time frame: Immediately after the simulated scenario
Communication quality (Likert)
Time frame: Immediately after the simulated scenario
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bernhard Rössler, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Tele-Support and Cognitive Aid in people with Shoulder Dystocia, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathias Maleczek, MD (+4314040041020, mathias.maleczek@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total performance score (time frame: At completion of the simulated shoulder dystocia scenario). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.