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Breech Presentation in PregnancyNCT07635667

High-Fidelity Simulation-Based Breech Birth Education in Midwifery Students

A study testing High-Fidelity Simulation-Based Breech Birth Education and Low-Fidelity Mannequin-Based Breech Birth Practice in people with Breech Presentation in Pregnancy and Midwifery Education, run by Karabuk University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this randomized controlled clinical trial is to evaluate whether high-fidelity simulation-based breech birth management education improves knowledge, clinical skill performance, and satisfaction among midwifery students. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
High-Fidelity Simulation-Based Breech Birth Education and Low-Fidelity Mannequin-Based Breech Birth Practice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Feb 2025to 30 May 2025
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Undergraduate midwifery students enrolled in the midwifery program.
  • Students who had completed the normal birth course.
  • Students who had not yet taken the high-risk birth course.
  • Students who had no previous clinical or simulation experience related to breech birth management.
  • Students who agreed to participate in the study voluntarily.

Who cannot join

  • Students who had previously received training or had clinical experience related to breech birth management.
  • Students who had taken the high-risk birth course before the study.
  • Students who did not attend the theoretical education or practical training session.
  • Students who did not complete the data collection forms.
  • Students who withdrew from the study at any stage.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Karabuk University

    Karabük, Karabük Province, 78050

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effectiveness of High-Fidelity Simulation-Based Breech Birth Management Education on Midwifery Students: A Randomized Controlled Study

The purpose of this randomized controlled clinical trial is to evaluate whether high-fidelity simulation-based breech birth management education improves knowledge, clinical skill performance, and satisfaction among midwifery students.

The main questions this study aims to answer are:

Read more

Does high-fidelity simulation-based breech birth education improve midwifery students' knowledge levels compared with low-fidelity mannequin-based practice?

Does high-fidelity simulation-based breech birth education improve midwifery students' clinical skill performance compared with low-fidelity mannequin-based practice?

Researchers will compare midwifery students receiving high-fidelity simulation-based breech birth education with students receiving low-fidelity mannequin-based practice to determine whether the high-fidelity simulation method is more effective in improving breech birth management knowledge and skills.

Participants will:

Complete a pre-test assessing breech birth knowledge before the educational intervention.

Receive theoretical education on breech birth management.

Be randomly assigned to either the high-fidelity simulation group or the low-fidelity mannequin-based practice group.

Complete a post-test assessing breech birth knowledge after the intervention.

Be evaluated for breech birth management skills using a structured skill assessment form.

Complete a simulation satisfaction scale after the simulation-based education.

Read the detailed description

This randomized controlled educational intervention study was designed to evaluate the effectiveness of high-fidelity simulation-based breech birth management education on undergraduate midwifery students' knowledge, clinical skill performance, and satisfaction with the simulation-based learning experience.

Breech presentation and breech birth management are important topics in midwifery education because they require rapid clinical assessment, appropriate decision-making, effective teamwork, and correct application of obstetric skills. Although vaginal breech birth is encountered less frequently in contemporary obstetric practice, midwives are expected to understand the principles of breech birth management and to be prepared to respond appropriately in situations where breech birth occurs. However, undergraduate midwifery students may have limited opportunities to observe or actively participate in the management of breech birth during clinical practice. This limitation may affect their ability to develop confidence, decision-making ability, and psychomotor skills related to rare but critical obstetric events.

Simulation-based education provides a structured and safe learning environment in which students can practice clinical skills and decision-making without risk to mothers or newborns. High-fidelity simulation allows learners to experience a more realistic clinical scenario by using a simulator and environment that more closely resemble real clinical conditions. In contrast, low-fidelity mannequin-based practice generally focuses on procedural steps and psychomotor skill development with a simpler training model. This study was planned to compare these two educational approaches in the context of breech birth management education.

The study was conducted with undergraduate midwifery students who met the eligibility criteria. Students were eligible to participate if they had completed the normal birth course, had not yet taken the high-risk birth course, and had no previous experience with breech birth. These criteria were used to ensure that participants had a basic foundation in normal birth while limiting the potential influence of previous education or clinical experience related to high-risk birth and breech birth management. Students who did not meet the eligibility criteria, who had previous experience with breech birth, or who did not agree to participate were not included in the study.

A total of 102 eligible midwifery students were included in the study. Participants were randomly assigned to two parallel groups using a simple randomization method. The experimental group consisted of 51 students who received theoretical education followed by high-fidelity simulation-based breech birth management training. The control group consisted of 51 students who received the same theoretical education followed by low-fidelity mannequin-based practice. The theoretical content was provided to both groups in order to ensure that all students received comparable baseline instruction before the practical training component.

The educational content included the definition and types of breech presentation, recognition of breech birth, principles of intrapartum assessment and management, criteria related to vaginal breech birth, possible maternal and neonatal risks, complications that may occur during breech birth, and basic obstetric maneuvers used in breech birth management. The training also addressed the importance of timely decision-making, appropriate communication, maintaining maternal and fetal safety, and recognizing situations requiring additional support or referral.

Before the educational intervention, all participants completed a pre-test to assess their baseline knowledge of breech birth management. After the theoretical education and practical training sessions, participants completed a post-test to evaluate changes in knowledge. The pre-test and post-test were used to determine whether the educational intervention contributed to improvement in students' knowledge levels.

In the experimental group, students participated in a high-fidelity simulation-based breech birth scenario. The simulation process included orientation to the simulation environment, explanation of the learning objectives, introduction to the simulator and available equipment, and preparation for the scenario. Students were expected to apply the knowledge and skills required for breech birth management within a realistic simulated clinical setting. The high-fidelity simulation scenario was designed to support clinical reasoning, psychomotor skill performance, decision-making, and preparedness for a rare obstetric situation. After the scenario, students participated in feedback and debriefing activities intended to support reflection on their performance, reinforce learning points, and identify areas for improvement.

In the control group, students received the same theoretical education and then practiced breech birth management using a low-fidelity mannequin-based training model. This practice allowed students to review and apply the basic procedural steps of breech birth management using a simpler educational model. The control intervention was included to compare the effect of high-fidelity simulation with a more traditional low-fidelity practice approach.

Clinical skill performance was assessed using a structured breech birth skill assessment form. The skill assessment focused on students' ability to perform the required steps of breech birth management in an appropriate sequence and to apply relevant obstetric maneuvers correctly. The assessment was used to compare clinical skill performance between the experimental and control groups after the educational intervention.

In addition to knowledge and skill outcomes, satisfaction with the simulation-based learning experience was evaluated among students who participated in the simulation-based education. A simulation satisfaction scale was used to assess students' perceptions of the educational process, including their satisfaction with the simulation experience, perceived contribution to learning, and perceived usefulness of the simulation for clinical preparation.

The primary purpose of this study was to determine whether high-fidelity simulation-based breech birth management education improves undergraduate midwifery students' knowledge and clinical skill performance compared with low-fidelity mannequin-based practice. The study also aimed to evaluate students' satisfaction with the high-fidelity simulation-based learning experience. The comparison between the experimental and control groups was intended to provide evidence regarding the educational value of high-fidelity simulation in teaching breech birth management to midwifery students.

This study involved an educational intervention only. No drug, biological product, surgical procedure, diagnostic test, or medical device intervention was administered to participants. Participants were undergraduate midwifery students, and no patient care was provided as part of the study. The study was conducted in an educational setting and focused on the development of knowledge, skill performance, and satisfaction related to breech birth management education.

Being tested
High-Fidelity Simulation-Based Breech Birth Education, Low-Fidelity Mannequin-Based Breech Birth Practice
Keywords
Breech birth, High-fidelity simulation, Midwifery students, Simulation-based education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-Fidelity Simulation-Based Breech Birth EducationBehavioural

    This educational intervention consisted of theoretical education followed by high-fidelity simulation-based breech birth management training. The simulation scenario was designed to support students' knowledge, clinical skill performance, decision-making, and preparedness for breech birth management.

  • Low-Fidelity Mannequin-Based Breech Birth PracticeBehavioural

    This educational intervention consisted of theoretical education followed by low-fidelity mannequin-based practice. The practice allowed students to perform the basic steps and obstetric maneuvers of breech birth management using a low-fidelity training model.

Study groups in NCT07635667
Study groupRoleWhat they receive
High-Fidelity Simulation GroupExperimentalParticipants in this group received theoretical education on breech birth management followed by high-fidelity simulation-based breech birth management training. The training included orientation to the simulation environment, scenario-based practice, and feedback/debriefing.
Receives: Behavioral: High-Fidelity Simulation-Based Breech Birth Education
Low-Fidelity Mannequin Practice GroupActive comparatorParticipants in this group received the same theoretical education on breech birth management followed by low-fidelity mannequin-based practice. The practice focused on the basic procedural steps and obstetric maneuvers used in breech birth management.
Receives: Behavioral: Low-Fidelity Mannequin-Based Breech Birth Practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Breech Birth Knowledge Score

    Breech birth knowledge was assessed using a structured knowledge test developed for the study. The test evaluated students' knowledge of breech presentation, intrapartum management principles, possible complications, and basic maneuvers used in breech birth management. Higher scores indicate a higher level of knowledge.

    Measured: Baseline and immediately after the educational intervention

  2. Breech Birth Skill Performance Score

    Breech birth management skill performance was assessed using a structured skill assessment form. The form evaluated students' ability to perform the required steps of breech birth management and obstetric maneuvers in an appropriate sequence. Higher scores indicate better clinical skill performance.

    Measured: Immediately after the practical training session

Secondary outcomes (1)
  1. Simulation Experience Satisfaction Score

    Students' satisfaction with the simulation-based learning experience was assessed using a simulation satisfaction scale. The scale evaluated students' perceptions of the simulation experience, its contribution to learning, and its usefulness for clinical preparation. Higher scores indicate higher satisfaction with the simulation-based learning experience.

    Measured: Immediately after the simulation-based education

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2026
  2. Study start15 Feb 2025
  3. Primary completion1 Apr 2025
  4. Study completion30 May 2025

Resources

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
Participants were randomly assigned to two parallel groups. The experimental group received theoretical education followed by high-fidelity simulation-based breech birth management training, while the control group received the same theoretical education followed by low-fidelity mannequin-based practice.
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07635667
Sponsor's protocol ID
KBU-EBE-MAKAT-2024-2020
Status last verified
Mar 2025
First submitted
3 Jun 2026
Last updated
9 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 the data were collected from students within an educational study and contain confidential participant-level information. Only aggregated and anonymized study findings will be reported in the thesis and related scientific publications.

Questions about this trial

What is this clinical trial studying?

A study testing High-Fidelity Simulation-Based Breech Birth Education and Low-Fidelity Mannequin-Based Breech Birth Practice in people with Breech Presentation in Pregnancy and Midwifery Education, run by Karabuk University 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 5 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 9 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?

Change in Breech Birth Knowledge Score (time frame: Baseline and immediately after the educational intervention). The study lists 2 primary outcomes in all. 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 9 Jun 2026.

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