A novel method to gain force awareness in a simulated childbirth and reduce the fetal head traction force
| ISRCTN | ISRCTN11223186 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11223186 |
| Secondary identifying numbers | 218/2024 |
- Submission date
- 26/10/2025
- Registration date
- 29/10/2025
- Last edited
- 29/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
When excessive traction force is used on a baby’s head during childbirth, studies show that this can cause injuries or complications in the newborn. Application of too much force can happen during a forceps or vacuum-assisted birth, when the baby’s shoulders get stuck (shoulder dystocia), or when the baby is very large or not positioned properly. Excessive force can stretch the nerves in the baby’s neck (the brachial plexus), which may cause injury. This type of injury, called neonatal brachial plexus injury (BPI), happens in about 0.4 to 4 out of every 1,000 live births and is one of the most common causes of legal cases related to childbirth in the UK. About 10–30% of affected babies are left with long-term nerve damage that affects the growth and movement of the arm. Because of this, it’s important for healthcare professionals to be trained to control the amount of force they use during delivery. However, training simulators that can measure the amount of force applied are expensive and not yet widely used. This study aimed to find out, through a randomized controlled trial, whether using a birth simulator that measures force can help trainees become more aware of how much force they use—both in normal births and in complicated births with shoulder dystocia—and whether that awareness lasts over time.
Who can participate?
Third-year midwifery students in their undergraduate studies at the University of Western Macedonia, Greece.
What does the study involve?
The study involves randomization of midwifery students to attend a one-day workshop to group A (intervention) and group B (controls).
All students will be assessed with regards to the traction force applied to the fetal head in both a normal vaginal birth and in a childbirth complicated with shoulder dystocia, using a high-fidelity computerised birthing-simulator with an integrated force-monitoring system.
All students will participate in a pre-training assessment, theoretical and practical training, and completed a post-training assessment.
The intervention involves students acquiring force awareness by applying fetal head traction and at the same time having immediate visual feedback of forces on a screen provided by the simulator’s force-monitoring system. The students will receive the intervention following their theoretical and practical training, but prior to the final post-training assessment.
The students from both groups (intervention-controls) will also be invited to attend a single follow-up assessment 6-months in order to assess whether the reduction in traction forces is retained.
What are the possible benefits and risks of participating?
The students participating will have the benefit of improving their fetal head traction skills. There are no risks associated with participating.
Where is the study run from?
University of Western Macedonia in Greece.
When is the study starting and how long is it expected to run for?
May 2025 to November 2026.
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Dimitrios Papoutsis, dpapoutsis@uowm.gr
Contact information
Public, Scientific, Principal investigator
KEPTSE area, Ptolemaida
Kozani
50200
Greece
 ORCID ID |
0000-0001-9921-1120 |
|---|---|
| Phone | +30 24610 68050 |
| dpapoutsis@uowm.gr |
Study information
| Study design | Single center interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | A novel method to gain force awareness in a simulated childbirth and reduce the fetal head traction force; a randomised controlled trial |
| Study acronym | FORCE study |
| Study objectives | This is a randomized controlled trial (RCT) where we seek to explore whether the use of the force-monitoring system of a high-fidelity birth simulator as a training tool in a simulated normal vaginal childbirth and in a simulated childbirth complicated with shoulder dystocia can potentially lead to improved force awareness. Our hypothesis was that the intervention may result in the reduction of the fetal head traction forces in simulated childbirth. |
| Ethics approval(s) |
Approved 30/05/2024, Research Ethics Committee of the University of Western Macedonia, Greece (ZEP area - University of Western Macedonia Kozani Greece, Kozani, 50100, Greece; +30 24610 56500; ehde@uowm.gr), ref: 218/30.05.2024 |
| Health condition(s) or problem(s) studied | How to to reduce the forces applied to the fetal head in a simulated normal childbirth and in a simulated childbirth complicated by shoulder dystocia.. |
| Intervention | Midwifery students are invited to participate in a 1-day workshop and are randomized to either group A (intervention) or group B (controls). All students will be assessed with regards to the traction force applied to the fetal head in both a normal vaginal birth and in a childbirth complicated with shoulder dystocia, using a high-fidelity computerised birthing-simulator with an integrated force-monitoring system. All students will participate in a pre-training assessment, theoretical and practical training, and completed a post-training assessment. The intervention involves students acquiring force awareness by applying fetal head traction and at the same time having immediate visual feedback of forces on a screen provided by the simulator’s force-monitoring system. The students will receive the intervention following their theoretical and practical training, but prior to the final post-training assessment. The students from both groups (intervention-controls) will also be invited to attend a single follow-up assessment 6-months in order to assess whether the reduction in traction forces is retained. Method of randomization: Computer-generated sequence of random numbers against the alphabetical list of students. |
| Intervention type | Behavioural |
| Primary outcome measure | Fetal head traction force will be measured using a calibrated force sensor embedded in the simulation model at baseline and post-training |
| Secondary outcome measures | Retention of skills at least 6-months later, measured by comparing the value of traction force 6-months later with the post-training values recorded at the end of the baseline workshop |
| Overall study start date | 18/01/2024 |
| Completion date | 30/11/2026 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Adult |
| Lower age limit | 19 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target number of participants | 100 |
| Key inclusion criteria | Third-year midwifery students of the University of Western Macedonia, Greece |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 11/05/2024 |
| Date of final enrolment | 30/05/2026 |
Locations
Countries of recruitment
- Greece
Study participating centre
Ptolemaida
50200
Greece
Sponsor information
University/education
ZEP area
Kozani
50100
Greece
| Phone | +30 24610 56270 |
|---|---|
| tdp@uowm.gr | |
| Website | https://www.uowm.gr |
"ROR" |
https://ror.org/00a5pe906 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/11/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Dimitrios Papoutsis (dpapoutsis@uowm.gr) |
Editorial Notes
27/10/2025: Trial's existence confirmed by Research Ethics Committee of the University of Western Macedonia, Greece.
