Postpartum HemorrhageNCT07618442
Effect of Simulation-Based Education on Knowledge, Skills, and Self-Efficacy in Postpartum Hemorrhage Management
A study testing Simulation-Based Postpartum Hemorrhage Management Education and Traditional Theoretical Postpartum Hemorrhage Education in people with Postpartum Hemorrhage and Obstetric Care, run by Ömercan Aksoy at 1 site in Turkey (Türkiye).
Trial summary
Postpartum hemorrhage is an important obstetric emergency that requires early recognition and timely management. Midwifery students may have limited opportunities to practise postpartum hemorrhage management repeatedly in real clinical settings. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage, Obstetric Care, Simulation Based Medical Education
- What is being tested?
- Simulation-Based Postpartum Hemorrhage Management Education and Traditional Theoretical Postpartum Hemorrhage Education
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Third-year undergraduate midwifery students enrolled in the Department of Midwifery during the 2022-2023 academic year
- Completion of the Normal Birth and Midwifery Care course
- Enrollment in the High-Risk Birth and Midwifery Care course during the study period
- Voluntary agreement to participate in the study
- Ability to attend all study sessions and follow-up assessments
Who cannot join
- Previous participation in structured postpartum hemorrhage simulation-based training
- Absence from any part of the educational intervention or outcome assessments
- Withdrawal of consent during the study period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University - Cerrahpasa
Istanbul, 34055
About this study
Official title: Effect of Simulation-Based Education on Knowledge, Skills, and Self-Efficacy in Postpartum Hemorrhage Management: A Randomized Controlled Trial
Postpartum hemorrhage is an important obstetric emergency that requires early recognition and timely management. Midwifery students may have limited opportunities to practise postpartum hemorrhage management repeatedly in real clinical settings. Simulation-based education may help students practise assessment, decision-making, emergency interventions, communication, and documentation in a safe learning environment.
This study evaluated the effect of simulation-based education on third-year midwifery students' knowledge, postpartum hemorrhage management skill performance, and self-efficacy. Participants were randomly assigned to either an intervention group or a control group. Both groups received traditional theoretical education on postpartum hemorrhage management. The intervention group additionally received simulation-based postpartum hemorrhage management education using a high-fidelity birthing simulator.
Knowledge and self-efficacy were assessed before the intervention, immediately after the intervention, and four weeks later. Skill performance was assessed immediately after the intervention and again four weeks later using a structured skills checklist. The study aimed to determine whether simulation-based education improved students' learning outcomes compared with traditional theoretical education alone.
Read the detailed description
This randomized controlled study was designed to evaluate the effect of simulation-based education on midwifery students' learning outcomes in postpartum hemorrhage management. The study was conducted with third-year undergraduate midwifery students at a university in Istanbul, Türkiye.
Eligible participants were third-year midwifery students who had completed the Normal Birth and Midwifery Care course and were enrolled in the High-Risk Birth and Midwifery Care course during the 2022-2023 academic year. Students who agreed to participate were randomly assigned to an intervention group or a control group.
All participants first received traditional theoretical education on postpartum hemorrhage management. The theoretical education included the definition, importance, etiology, risk factors, prevention, treatment, and management of postpartum hemorrhage. The intervention group then received additional simulation-based postpartum hemorrhage management education. The simulation session was conducted in a simulation laboratory arranged as a postpartum patient room and used a high-fidelity birthing simulator. The simulation included prebriefing, a postpartum hemorrhage scenario, and debriefing. Moulage and clinical equipment were used to support scenario realism.
The control group received traditional theoretical education only and did not participate in the simulation-based education session. Participants in both groups completed the same outcome assessments.
The primary learning outcomes were postpartum hemorrhage management knowledge, skill performance, and self-efficacy. Knowledge was measured using the Postpartum Hemorrhage Management Knowledge Test. Self-efficacy was measured using the Postpartum Hemorrhage Management Self-Efficacy Form. Skill performance was assessed using the Postpartum Hemorrhage Management Skills Checklist by external observers.
Knowledge and self-efficacy were measured at three time points: baseline, immediately after the intervention, and four weeks after the intervention. Skill performance was assessed immediately after the intervention and at the four-week follow-up. The study compared changes in these outcomes between the intervention and control groups to determine whether simulation-based education provided additional benefit beyond traditional theoretical education.
- Being tested
- Simulation-Based Postpartum Hemorrhage Management Education, Traditional Theoretical Postpartum Hemorrhage Education
- Keywords
- Postpartum hemorrhage, Simulation-based education, High-fidelity simulation, Midwifery education, Postpartum hemorrhage management
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-Based Postpartum Hemorrhage Management EducationBehavioural
Also called Simulation-based PPH management education
Simulation-based education was delivered using a high-fidelity birthing simulator in a simulation laboratory arranged as a postpartum patient room. The session included a 5-minute prebriefing, a 15-minute postpartum hemorrhage management scenario, and a 30-minute debriefing. The scenario required learners to assess vital signs, lochia, fundus, pain, and IV catheter status; recognize postpartum hemorrhage; communicate using SBAR; initiate emergency interventions; and document care.Simulation-based education was delivered using a high-fidelity birthing simulator in a simulation laboratory arranged as a postpartum patient room. The session included a 5-minute prebriefing, a 15-minute postpartum hemorrhage management scenario, and a 30-minute debriefing. The scenario required learners to assess vital signs, lochia, fundus, pain, and IV catheter status; recognize postpartum hemorrhage; communicate using SBAR; initiate emergency interventions; and document care.
Traditional Theoretical Postpartum Hemorrhage EducationBehavioural
Also called Traditional theoretical PPH education
Traditional theoretical education was delivered face-to-face in a classroom setting and lasted approximately one hour. The session covered the definition, importance, etiology, risk factors, prevention, treatment, and management of postpartum hemorrhage. The education was supported by a PowerPoint presentation and included lecture, question-answer, discussion, and brainstorming methods.
| Study group | Role | What they receive |
|---|---|---|
| Simulation-Based PPH Management Education Group | Experimental | Participants in this arm received traditional theoretical education on postpartum hemorrhage management followed by simulation-based postpartum hemorrhage management education using a high-fidelity birthing simulator. The simulation session included prebriefing, a postpartum hemorrhage scenario, and debriefing. Receives: Behavioral: Simulation-Based Postpartum Hemorrhage Management Education; Behavioral: Traditional Theoretical Postpartum Hemorrhage Education |
| Traditional Theoretical PPH Education Group | Active comparator | Participants in this arm received traditional theoretical education on postpartum hemorrhage management only. They did not receive simulation-based education during the study period. Receives: Behavioral: Traditional Theoretical Postpartum Hemorrhage Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPH Management Skill Performance Score
PPH management skill performance was assessed using the Postpartum Hemorrhage Management Skills Checklist. The checklist includes 23 items scored as 0 = needs improvement, 1 = partially adequate, and 2 = adequate. Total scores range from 0 to 46, with higher scores indicating better PPH management skill performance.PPH management skill performance was assessed using the Postpartum Hemorrhage Management Skills Checklist. The checklist includes 23 items scored as 0 = needs improvement, 1 = partially adequate, and 2 = adequate. Total scores range from 0 to 46, with higher scores indicating better PPH management skill performance.
Measured: Post-intervention and four-week follow-up
Secondary outcomes (2)
PPH Management Knowledge Score
PPH management knowledge was assessed using the Postpartum Hemorrhage Management Knowledge Test. The test includes 23 items scored as 0 = incorrect and 1 = correct. Total scores range from 0 to 23, with higher scores indicating higher knowledge of PPH management.
Measured: Baseline, post-intervention, and four-week follow-up
PPH Management Self-Efficacy Score
PPH management self-efficacy was assessed using the Postpartum Hemorrhage Management Self-Efficacy Form. The form includes 13 items rated on a five-point Likert scale. Total scores range from 13 to 65, with higher scores indicating higher perceived self-efficacy in PPH management.
Measured: Baseline, post-intervention, and four-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 May 2023
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ömercan Aksoy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ömercan Aksoy, Istanbul Topkapi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618442
- Sponsor's protocol ID
- E-22686390-050.99-24891
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because participant consent did not include permission for sharing de-identified individual-level data outside the primary research group.
Publications
Aksoy O, Aslan E. Simulation-based education improves postpartum hemorrhage management knowledge and skills: a randomized controlled trial. Front Med (Lausanne). 2026 Sep 29;13:1939595. doi: 10.3389/fmed.2026.1939595. eCollection 2026.
PubMed 42870869
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Simulation-Based Education on Knowledge, Skills, and Self-Efficacy in Postpartum Hemorrhage Management: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07618442
- Acronym / sponsor ID
- E-22686390-050.99-24891
- Keywords
- Postpartum hemorrhage, Simulation-based education, High-fidelity simulation, Midwifery education, Postpartum hemorrhage management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ömercan AksoyUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 1 Jun 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.
Postpartum hemorrhage is an important obstetric emergency that requires early recognition and timely management. Midwifery students may have limited opportunities to practise postpartum hemorrhage management repeatedly in real clinical settings. Simulation-based education may help students practise assessment, decision-making, emergency interventions, communication, and documentation in a safe learning environment.
This study evaluated the effect of simulation-based education on third-year midwifery students' knowledge, postpartum hemorrhage management skill performance, and self-efficacy. Participants were randomly assigned to either an intervention group or a control group. Both groups received traditional theoretical education on postpartum hemorrhage management. The intervention group additionally received simulation-based postpartum hemorrhage management education using a high-fidelity birthing simulator.
Knowledge and self-efficacy were assessed before the intervention, immediately after the intervention, and four weeks later. Skill performance was assessed immediately after the intervention and again four weeks later using a structured skills checklist. The study aimed to determine whether simulation-based education improved students' learning outcomes compared with traditional theoretical education alone.
Detailed description
This randomized controlled study was designed to evaluate the effect of simulation-based education on midwifery students' learning outcomes in postpartum hemorrhage management. The study was conducted with third-year undergraduate midwifery students at a university in Istanbul, Türkiye.
Eligible participants were third-year midwifery students who had completed the Normal Birth and Midwifery Care course and were enrolled in the High-Risk Birth and Midwifery Care course during the 2022-2023 academic year. Students who agreed to participate were randomly assigned to an intervention group or a control group.
All participants first received traditional theoretical education on postpartum hemorrhage management. The theoretical education included the definition, importance, etiology, risk factors, prevention, treatment, and management of postpartum hemorrhage. The intervention group then received additional simulation-based postpartum hemorrhage management education. The simulation session was conducted in a simulation laboratory arranged as a postpartum patient room and used a high-fidelity birthing simulator. The simulation included prebriefing, a postpartum hemorrhage scenario, and debriefing. Moulage and clinical equipment were used to support scenario realism.
The control group received traditional theoretical education only and did not participate in the simulation-based education session. Participants in both groups completed the same outcome assessments.
The primary learning outcomes were postpartum hemorrhage management knowledge, skill performance, and self-efficacy. Knowledge was measured using the Postpartum Hemorrhage Management Knowledge Test. Self-efficacy was measured using the Postpartum Hemorrhage Management Self-Efficacy Form. Skill performance was assessed using the Postpartum Hemorrhage Management Skills Checklist by external observers.
Knowledge and self-efficacy were measured at three time points: baseline, immediately after the intervention, and four weeks after the intervention. Skill performance was assessed immediately after the intervention and at the four-week follow-up. The study compared changes in these outcomes between the intervention and control groups to determine whether simulation-based education provided additional benefit beyond traditional theoretical education.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation-Based PPH Management Education Group | Experimental | Behavioral: Simulation-Based Postpartum Hemorrhage Management Education, Behavioral: Traditional Theoretical Postpartum Hemorrhage EducationParticipants in this arm received traditional theoretical education on postpartum hemorrhage management followed by simulation-based postpartum hemorrhage management education using a high-fidelity birthing simulator. The simulation session included prebriefing, a postpartum hemorrhage scenario, and debriefing. |
| Traditional Theoretical PPH Education Group | Active comparator | Behavioral: Traditional Theoretical Postpartum Hemorrhage EducationParticipants in this arm received traditional theoretical education on postpartum hemorrhage management only. They did not receive simulation-based education during the study period. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Third-year undergraduate midwifery students enrolled in the Department of Midwifery during the 2022-2023 academic year
- Completion of the Normal Birth and Midwifery Care course
- Enrollment in the High-Risk Birth and Midwifery Care course during the study period
- Voluntary agreement to participate in the study
- Ability to attend all study sessions and follow-up assessments
Key exclusion criteria (3 listed)
- Previous participation in structured postpartum hemorrhage simulation-based training
- Absence from any part of the educational intervention or outcome assessments
- Withdrawal of consent during the study period
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 |
|---|---|---|
| Simulation-Based Postpartum Hemorrhage Management EducationAlso: Simulation-based PPH management educationSimulation-based education was delivered using a high-fidelity birthing simulator in a simulation laboratory arranged as a postpartum patient room. The session included a 5-minute prebriefing, a 15-minute postpartum hemorrhage management scenario, and a 30-minute debriefing. The scenario required learners to assess vital signs, lochia, fundus, pain, and IV catheter status; recognize postpartum hemorrhage; communicate using SBAR; initiate emergency interventions; and document care.Simulation-based education was delivered using a high-fidelity birthing simulator in a simulation laboratory arranged as a postpartum patient room. The session included a 5-minute prebriefing, a 15-minute postpartum hemorrhage management scenario, and a 30-minute debriefing. The scenario required learners to assess vital signs, lochia, fundus, pain, and IV catheter status; recognize postpartum hemorrhage; communicate using SBAR; initiate emergency interventions; and document care. | Behavioural | Simulation-Based PPH Management Education Group |
| Traditional Theoretical Postpartum Hemorrhage EducationAlso: Traditional theoretical PPH educationTraditional theoretical education was delivered face-to-face in a classroom setting and lasted approximately one hour. The session covered the definition, importance, etiology, risk factors, prevention, treatment, and management of postpartum hemorrhage. The education was supported by a PowerPoint presentation and included lecture, question-answer, discussion, and brainstorming methods. | Behavioural | Simulation-Based PPH Management Education Group, Traditional Theoretical PPH Education Group |
Primary outcome
PPH Management Skill Performance Score
Time frame: Post-intervention and four-week follow-up
PPH management skill performance was assessed using the Postpartum Hemorrhage Management Skills Checklist. The checklist includes 23 items scored as 0 = needs improvement, 1 = partially adequate, and 2 = adequate. Total scores range from 0 to 46, with higher scores indicating better PPH management skill performance.PPH management skill performance was assessed using the Postpartum Hemorrhage Management Skills Checklist. The checklist includes 23 items scored as 0 = needs improvement, 1 = partially adequate, and 2 = adequate. Total scores range from 0 to 46, with higher scores indicating better PPH management skill performance.
2 secondary outcomes
PPH Management Knowledge Score
Time frame: Baseline, post-intervention, and four-week follow-up
PPH Management Self-Efficacy Score
Time frame: Baseline, post-intervention, and four-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Derived from this study: PubMed 42870869Aksoy O, Aslan E. Simulation-based education improves postpartum hemorrhage management knowledge and skills: a randomized controlled trial. Front Med (Lausanne). 2026 Sep 29;13:1939595. doi: 10.3389/fmed.2026.1939595. eCollection 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because participant consent did not include permission for sharing de-identified individual-level data outside the primary research group.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation-Based Postpartum Hemorrhage Management Education and Traditional Theoretical Postpartum Hemorrhage Education in people with Postpartum Hemorrhage and Obstetric Care, run by Ömercan Aksoy at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 2 Jun 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PPH Management Skill Performance Score (time frame: Post-intervention and four-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07618442, which also lists 1 linked publication.
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 2 Jun 2026.