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Completed

NCT Number: NCT07618442

Effect of Simulation-Based Education on Knowledge, Skills, and Self-Efficacy in Postpartum Hemorrhage Management

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.

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Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Care Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Simulation Based Medical Education Urogenital Diseases Uterine Hemorrhage

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University - Cerrahpasa

Istanbul, 34055, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Simulation-Based Postpartum Hemorrhage Management Education

Behavioral

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.

Other names: Simulation-based PPH management education

Traditional Theoretical Postpartum Hemorrhage Education

Behavioral

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.

Other names: Traditional theoretical PPH education

Primary outcomes

  1. 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.

Secondary outcomes

  1. PPH Management Knowledge Score

    Time frame: Baseline, post-intervention, and four-week follow-up

    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.

  2. PPH Management Self-Efficacy Score

    Time frame: Baseline, post-intervention, and four-week follow-up

    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.

Sponsors and collaborators

Lead sponsor

Ömercan Aksoy

Other

Registry information

Official study title

Effect of Simulation-Based Education on Knowledge, Skills, and Self-Efficacy in Postpartum Hemorrhage Management: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 1, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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