Training in assisted birth: the TAB study
| ISRCTN | ISRCTN70998989 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70998989 |
| Secondary identifying numbers | 2.1 |
- Submission date
- 23/07/2018
- Registration date
- 07/08/2018
- Last edited
- 26/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
The BD Odon Device is a new device to help with assisted vaginal birth (AVB). It could potentially reduce the risk of injury to the mother and baby, as its mechanism of action is different to that of forceps and vacuum extraction. Before the device’s use in clinical trials the researchers wish to devise and explore the potential benefits of an AVB training programme. Studies of AVB conclude that simulation and training should logically come before clinical experience, allowing for absorption of knowledge and skills in a safe environment. Simulation has been also suggested as an important training technique to increase trainees’ confidence. The Royal College of Obstetricians and Gynaecologists (RCOG) guidance on performing AVB has a clear assessment method through the objective structured assessment of training skills (OSATS). This consists of evaluation of generic technical skills and evaluation of key operative steps. The aim of this study is to explore the effect of simulation training with the BD Odon Device.
Who can participate?
Qualified doctors working clinically in obstetrics
What does the study involve?
Participants undertake an AVB training session. This includes an instructional video on the use of the BD Odon Device and intensive 1:1 practical teaching of how to use the BD Odon Device on a high-fidelity pelvic simulator. Training also includes revision and practice in the correct technique for using ventouse and forceps. Staff receive AVB training, including hands-on practical teaching on a high-fidelity pelvic simulator, as part of the current recognised Royal College of Obstetricians and Gynaecologists training course, ROBuST. Clinicians individually arrange a convenient time with the research team to undertake the training and training assessments; this is to fit around their clinical commitments. They participate in one or several visits, depending on availability and convenience.
What are the possible benefits and risks of participating?
Obstetricians have refresher teaching on AVB as well as training on the BD Odon Device, for some a new obstetrical instrument. It will aid their clinical skills and allow them to feel more confident with managing an AVB. Doctors may feel they do not wish to be assessed on a simulated AVB and may feel apprehensive about being compared to their peers. They may be concerned that they will not be able to complete the assessments. They are reassured that this is not in any way a formal assessment and will not be part of their own assessments or appraisal in any way. The results of this will be completely confidential and only seen by the research team. Participants are not under any obligation to take part in the study and may choose not to participate at any time.
Where is the study run from?
Southmead Hospital (UK)
When is the study starting and how long is it expected to run for?
November 2017 to September 2019
Who is funding the study?
Bill and Melinda Gates Foundation (USA)
Who is the main contact?
Dr Emily Hotton
emily.hotton@nhs.net
Contact information
Public
The Chilterns
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
 ORCID ID |
0000-0002-8570-9136 |
|---|---|
| Phone | +44 (0)1173232322 |
| emily.hotton@nhs.net |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Practitioner-reported confidence, competence and knowledge following training in assisted vaginal birth: an observational cohort study |
| Study acronym | TAB |
| Study hypothesis | This training assessment study aims to explore the effect of simulation training on a novel medical device in obstetrics across several domains. |
| Ethics approval(s) | This is a study that is on doctors working within their clinical capacity on simulation so does not require ethics approval. HRA approval was given 21/06/2018, IRAS number: 249279 |
| Condition | Simulation study, focussing on assisted vaginal birth within obstetrics |
| Intervention | The BD Odon Device is a technological innovation to facilitate the performance of assisted vaginal birth (AVB). The BD Odon Device presents specific features that could potentially reduce the risk of maternal and fetal injury, as its mechanism of action is different to that of forceps and vacuum extraction. Participants will undertake an assisted vaginal births training session. This will include an instructional video on the use of the BD Odon Device and intensive 1:1 practical teaching of how to use the BD Odon Device on a high-fidelity pelvic simulator. Training will also include revision and practice in the correct technique for using ventouse and forceps. Staff will be exposed to AVB training, including hands-on practical teaching on a high-fidelity pelvic simulator, as part of the current recognised Royal College of Obstetricians and Gynaecologists training course, ROBuST. Clinicians will individually arrange a convenient time with the research team to undertake the training and training assessments; this is to fit around their clinical commitments. They will participate in one or several visits, depending on availability and convenience. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Outcomes are measured at baseline (pre-training) and then again measured post training. This will be any time in the 2 weeks following training, depending on availability and convince of the participant: 1. Training success: ability to perform a delivery scored on a mark scheme for both practical and verbal recall 2. Change in confidence assessed upon their simulated delivery using a modified version of the six-item, five-point confidence scoring tool previously validated for gynaecology trainees and has already been used and adapted to assess confidence in assisted vaginal birth 3. Change in knowledge: five questions are asked requiring free text responses which have been devised by a multidisciplinary team |
| Secondary outcome measures | Outcomes are measured at baseline (pre-training) and then again measured post training. This will be any time in the 2 weeks following training, depending on availability and convince of the participant: Expectations and experiences of training, measured using three free text boxes exploring training expectations and five free text boxes exploring experiences of training |
| Overall study start date | 17/11/2017 |
| Overall study end date | 30/09/2019 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 10-30 |
| Participant inclusion criteria | 1. Qualified doctor and working clinically in obstetrics 2. Able to provide informed consent |
| Participant exclusion criteria | Physical disability or injury that would prevent participant from using the investigational device |
| Recruitment start date | 26/06/2018 |
| Recruitment end date | 30/06/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bristol
BS10 5NB
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Innovation Department
Learning & Research Building, Floor 3
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
England
United Kingdom
"ROR" |
https://ror.org/036x6gt55 |
|---|
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Bill & Melinda Gates Foundation, Gates Foundation, BMGF, B&MGF, GF
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The study protocol has not been published but it is available via open access. The URL is: https://research-information.bristol.ac.uk/en/publications/practitionerreported-confidence-competence-and-knowledge-following-training-in-assisted-vaginal-birth-an-observational-cohort-study-protocol(7c15dd50-93fb-486a-8bd1-15fc8ecad1dd).html All findings will be disseminated via the usual channels, i.e. national and international conferences and published in a peer-reviewed international medical journals. We will collaborate with international professional bodies such as the RCOG to implement best practice in maternity settings across the world. Furthermore, data from the study may will be included within the official RCOG-endorsed assisted birth training program, ROBuST. |
| IPD sharing plan | The data will be held on the University of Bristol server. It will not be made available immediately as some of the data may be used in another study. This is included in the consent form for the TAB study. |
Editorial Notes
26/04/2022: The following changes were made to the trial record:
1. The overall end date was changed from 30/06/2022 to 30/09/2019.
2. The recruitment end date was changed from 31/03/2022 to 30/06/2019.
3. The contact email was updated.
4. The plain English summary was updated to reflect these changes.
09/07/2020: The trial contact details have been made publicly visible.
21/02/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/01/2019 to 31/03/2022.
2. The overall trial end date was changed from 17/05/2019 to 30/06/2022.
3. The intention to publish date was changed from 06/06/2019 to 31/03/2023.
