PPH - Postpartum HemorrhageNCT07857551
Comparing Simulated Patients and Manikin Based Simulation in Obstetrics
A study testing Trained, standardized patient and MamaAnne Patient Simulator in people with PPH - Postpartum Hemorrhage and Eclampsia, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of this randomized study is to compare a live, trained simulated patient with a high-fidelity manikin in obstetric emergency team training using two standardized scenarios. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PPH - Postpartum Hemorrhage, Eclampsia
- What is being tested?
- Trained, standardized patient and MamaAnne Patient Simulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteAustria
- Study dates
- 15 Oct 2026to Jan 2029
- 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
- Individual inclusion criteria are: physician, midwife, registered nurse, or paramedic; current clinical duties in obstetric or peripartum emergency care
- written informed consent
Who cannot join
- Pregnancy
- Exclusion criteria are pregnancy and prior participation in a simulation study using the same obstetric scenarios.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Medical University of Vienna
Vienna, State of Vienna, 1090
Mathias Maleczek, PD Dr., +4314040041020, mathias.maleczek@meduniwien.ac.at
About this study
Official title: Effect of Manikin and Simulated-Patient Realism on Training Experience and Performance in Emergency Team Training: A Mixed-Methods Research Programme: Substudy C - Simulated Patient vs. MamaAnne for PPH and Eclampsia Team Training
The aim of this randomized study is to compare a live, trained simulated patient with a high-fidelity manikin in obstetric emergency team training using two standardized scenarios. The participants in this study are intact clinical teams (e.g., obstetrics, anesthesiology, and nursing/midwifery staff routinely working together in obstetric emergencies) and are recruited as a unit. Each team will either have both scenarios with the live, trained standard patient or the high fidelity manikin. Both scenarios are standardized: One scenario is about post-partum hemorrhage (PPH), a severe bleeding after giving birth, and the other scenario is about eclampsia, an emergency in obstetrics that causes hypertensive crisis and seizures. The order of scenarios is random. After each scenario all team members fill out questionnaires about realism and cognitive stress. After the second debriefing, a focus group of approximately 15 minutes is conducted with each team with a standardized procedure and questions.
Read the detailed description
The focus group is led by a moderator who did not facilitate either debriefing and who holds no supervisory relationship to any participant. A short semi-structured guide of five questions is used. The focus group is a separate element of the study and is not one of the two debriefings; it begins only once the second debriefing has been formally closed.
- Conditions
- PPH - Postpartum Hemorrhage, Eclampsia
- Being tested
- Trained, standardized patient, MamaAnne Patient Simulator
- Keywords
- Simulation, Eclampsia, PPH, Standardized Patient, Postpartum Hemorrhage
- Medical subject headings
- Postpartum Hemorrhage, Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trained, standardized patientOther
Also called Arm 1: Standardized Patient
Trained, standardized patient portraying obstetric woman with MamaNatalie simulator
MamaAnne Patient SimulatorOther
Patient portrayed by high fidelity obstetric manikin MamaAnne
| Study group | Role | What they receive |
|---|---|---|
| Trained Simulated Patient | Active comparator | Both scenarios portrayed by a trained Simulated Patient (PPH: verbalized pain/distress, simulated blood loss via MamaNatalie; eclampsia: seizure activity, verbal responses where clinically appropriate, hypertensive crisis presentation). Receives: Other: Trained, standardized patient |
| High-fidelity Manikin | Experimental | Both scenarios portrayed by a high fidelity obstetric manikin (PPH: verbalized pain/distress, simulated blood loss via MamaAnne; eclampsia: seizure activity, verbal responses where clinically appropriate, hypertensive crisis presentation). Receives: Other: MamaAnne Patient Simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
SRS-Score
Perceived realism of the simulation measured with the Simulation Realism Scale (SRS), completed individually by every team member after each of the two scenarios. Score range [min] to [max]; higher scores indicate greater perceived realism.
Measured: Immediately after each scenario (scenario 1 and scenario 2, on the day of training)
Secondary outcomes (2)
Perceived realism on a Numeric Rating Scale (NRS)
Single-item perceived realism rated on a Numeric Rating Scale (NRS) from 0 (not realistic at all) to 10 (completely realistic); higher scores indicate greater perceived realism. Completed individually by every team member after each scenario.
Measured: Immediately after each scenario (scenario 1 and scenario 2, on the day of training)
Themes on perceived realism and training experience (reflexive thematic analysis of focus groups)
Debriefing and focus group transcripts are analyzed together using reflexive thematic analysis. Two researchers code independently; a codebook is developed after the first four teams and applied to the remainder, with discrepancies resolved in consensus discussion and a third researcher consulted where consensus is not reached. Coders are not blinded to modality, since modality is evident from the transcript; this is reported as a limitation. Analytic adequacy is judged against information power rather than data saturation, taking into account the narrow study aim, the high specificity of the sample, and the use of an established theoretical frame.
Measured: Immediately after the debriefing of the second scenario, on the day of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PPH - Postpartum HemorrhageStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, randomized, controlled, split-plot trial. Modality (SP vs. Manikin) is randomized between teams (different teams per modality arm, 1:1 allocation); scenario (PPH, eclampsia) is a within-team factor, with each team completing both scenarios in a randomized order.
- Masking
- None (open label)
- Enrolment
- 72 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
- NCT07857551
- Sponsor's protocol ID
- Fidelity C
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Manikin and Simulated-Patient Realism on Training Experience and Performance in Emergency Team Training: A Mixed-Methods Research Programme: Substudy C - Simulated Patient vs. MamaAnne for PPH and Eclampsia Team Training
- ClinicalTrials.gov ID
- NCT07857551
- Acronym / sponsor ID
- Fidelity C
- Conditions
- PPH - Postpartum Hemorrhage, Eclampsia
- Keywords
- Simulation, Eclampsia, PPH, Standardized Patient, Postpartum Hemorrhage
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 5 Oct 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.
The aim of this randomized study is to compare a live, trained simulated patient with a high-fidelity manikin in obstetric emergency team training using two standardized scenarios. The participants in this study are intact clinical teams (e.g., obstetrics, anesthesiology, and nursing/midwifery staff routinely working together in obstetric emergencies) and are recruited as a unit. Each team will either have both scenarios with the live, trained standard patient or the high fidelity manikin. Both scenarios are standardized: One scenario is about post-partum hemorrhage (PPH), a severe bleeding after giving birth, and the other scenario is about eclampsia, an emergency in obstetrics that causes hypertensive crisis and seizures. The order of scenarios is random. After each scenario all team members fill out questionnaires about realism and cognitive stress. After the second debriefing, a focus group of approximately 15 minutes is conducted with each team with a standardized procedure and questions.
Detailed description
The focus group is led by a moderator who did not facilitate either debriefing and who holds no supervisory relationship to any participant. A short semi-structured guide of five questions is used. The focus group is a separate element of the study and is not one of the two debriefings; it begins only once the second debriefing has been formally closed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, randomized, controlled, split-plot trial. Modality (SP vs. Manikin) is randomized between teams (different teams per modality arm, 1:1 allocation); scenario (PPH, eclampsia) is a within-team factor, with each team completing both scenarios in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| Trained Simulated Patient | Active comparator | Other: Trained, standardized patientBoth scenarios portrayed by a trained Simulated Patient (PPH: verbalized pain/distress, simulated blood loss via MamaNatalie; eclampsia: seizure activity, verbal responses where clinically appropriate, hypertensive crisis presentation). |
| High-fidelity Manikin | Experimental | Other: MamaAnne Patient SimulatorBoth scenarios portrayed by a high fidelity obstetric manikin (PPH: verbalized pain/distress, simulated blood loss via MamaAnne; eclampsia: seizure activity, verbal responses where clinically appropriate, hypertensive crisis presentation). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individual inclusion criteria are: physician, midwife, registered nurse, or paramedic; current clinical duties in obstetric or peripartum emergency care
- written informed consent
Key exclusion criteria (2 listed)
- Pregnancy
- Exclusion criteria are pregnancy and prior participation in a simulation study using the same obstetric scenarios.
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 |
|---|---|---|
| Trained, standardized patientAlso: Arm 1: Standardized PatientTrained, standardized patient portraying obstetric woman with MamaNatalie simulator | Other | Trained Simulated Patient |
| MamaAnne Patient SimulatorPatient portrayed by high fidelity obstetric manikin MamaAnne | Other | High-fidelity Manikin |
Primary outcome
SRS-Score
Time frame: Immediately after each scenario (scenario 1 and scenario 2, on the day of training)
Perceived realism of the simulation measured with the Simulation Realism Scale (SRS), completed individually by every team member after each of the two scenarios. Score range [min] to [max]; higher scores indicate greater perceived realism.
2 secondary outcomes
Perceived realism on a Numeric Rating Scale (NRS)
Time frame: Immediately after each scenario (scenario 1 and scenario 2, on the day of training)
Themes on perceived realism and training experience (reflexive thematic analysis of focus groups)
Time frame: Immediately after the debriefing of the second scenario, on the day of training
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 5 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trained, standardized patient and MamaAnne Patient Simulator in people with PPH - Postpartum Hemorrhage and Eclampsia, 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 2 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 5 Oct 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, PD Dr. (+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?
SRS-Score (time frame: Immediately after each scenario (scenario 1 and scenario 2, on the day of training)). 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 5 Oct 2026.