NCT07618442

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 24, 2026

Last Update Submit

May 29, 2026

Conditions

Keywords

Postpartum hemorrhageSimulation-based educationHigh-fidelity simulationMidwifery educationPostpartum hemorrhage management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • PPH Management Knowledge Score

    Baseline, post-intervention, and four-week follow-up

  • PPH Management Self-Efficacy Score

    Baseline, post-intervention, and four-week follow-up

Study Arms (2)

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.

Behavioral: Simulation-Based Postpartum Hemorrhage Management EducationBehavioral: 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.

Behavioral: Traditional Theoretical Postpartum Hemorrhage Education

Interventions

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.

Also known as: Simulation-based PPH management education
Simulation-Based PPH Management Education Group

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.

Also known as: Traditional theoretical PPH education
Simulation-Based PPH Management Education GroupTraditional Theoretical PPH Education Group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University - Cerrahpasa

Istanbul, 34055, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Skill performance was assessed by two external expert observers who were not affiliated with the study setting and were blinded to group allocation. Due to the educational nature of the intervention, participants and investigators were not blinded.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 24, 2026

First Posted

June 1, 2026

Study Start

May 1, 2023

Primary Completion

June 15, 2023

Study Completion

June 15, 2023

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations