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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage; Simulation Based Medical Education; Obstetric Care
• Intervention / Treatment: Behavioral: Simulation-Based Postpartum Hemorrhage Management Education; Behavioral: Traditional Theoretical Postpartum Hemorrhage Education

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34055
    • Istanbul University - Cerrahpasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simulation-Based PPH Management Education Group; 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.	Behavioral: Simulation-Based Postpartum Hemorrhage 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.; Other Names: Simulation-based PPH management education; Behavioral: Traditional Theoretical Postpartum Hemorrhage 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.; Other Names: Traditional theoretical PPH education
Active Comparator: Traditional Theoretical PPH Education Group; Participants in this arm received traditional theoretical education on postpartum hemorrhage management only. They did not receive simulation-based education during the study period.	Behavioral: Traditional Theoretical Postpartum Hemorrhage 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.; Other Names: Traditional theoretical PPH education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Post-intervention and four-week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, post-intervention, and four-week follow-up

Collaborators and Investigators

• Sponsor: Ömercan Aksoy

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: May 24, 2026
• First Submitted That Met QC Criteria: May 24, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 24, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Postpartum hemorrhage; High-fidelity simulation; Simulation-based education; Midwifery education; Postpartum hemorrhage management
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Hemorrhage; Puerperal Disorders; Uterine Hemorrhage; Pathological Conditions, Signs and Symptoms; Postpartum Hemorrhage
• Other Study ID Numbers: E-22686390-050.99-24891

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data will not be shared because the dataset includes student-level educational performance data and the informed consent process did not include permission for public sharing of individual-level data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No