Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Laura Timlin
+44 (0)117 41 46762
laura.timlin@nbt.nhs.uk


Study Location:

Southmead Hospital (lead site)
North Bristol NHS Trust Southmead Road
Bristol
BS10 5NB


Skip to Main Content
Keep up to date

Sign up for news and information about taking part and shaping research.

The Simulation Training for Operative vaginal Birth – Evaluation (STROBE) study

Not Recruiting

Open to: Female

Age: Adult

Medical Conditions

Specialty: Reproductive health and childbirth, Primary sub-specialty: General Obstetrics/ Midwifery
UKCRC code/ Disease: Reproductive Health and Childbirth/ Delivery


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.




Background and study aims
Operative vaginal birth (OVB) is vaginal delivery of a baby performed with the help of forceps or a vacuum device. OVB is a vitally important tool which can improve outcomes in situations of full cervical dilation and either fetal distress or prolonged labour. OVB, compared to the alternative management (Caesarean section), is associated with lower rates of major maternal haemorrhage (bleeding), reduced analgesia (pain relief) requirements and shorter hospital stay. Babies delivered via OVB also have lower rates of admission to neonatal intensive care units. Currently there is no training course for obstetricians in OVB that has shown benefits in patient-related outcomes. The existing Royal College of Obstetricians and Gynaecologists (RCOG) Operative Birth Simulation Training (ROBUST) course is sporadically undertaken by junior trainees in England. This study involves delivering locally-delivered OVB training in four large maternity units within the South West of England. The innovative package of structured training has been developed by a multi-disciplinary team of obstetricians and midwives, in collaboration with the Royal College of Obstetricians and Gynaecologists (RCOG). The aim of this study is to implement this training course and compare routinely collected patient outcomes before and after training to establish the patient benefit of simulation training for all practitioners in OVB.

Who can participate?
Mothers who have an OVB

What does the study involve?
Trainees in Obstetrics and Gynaecology receive structured simulation training in OVB (the ROBuST course). The intervention is delivered by local faculty of senior obstetricians and midwives. The ROBuST course is a one-day course that uses simulation models to teach the spectrum of OVB manoeuvres – rotational and non-rotational forceps and vacuum deliveries, as well as techniques for complex Caesarean sections. Outcomes for mothers and babies who have had an OVB are collected before and between 3 months and 9 months after the delivery of training in each of the four maternity units.

What are the possible benefits and risks of participating?
This will be the first study to introduce and test a training intervention designed to improve the outcomes of OVB. Should this study demonstrate that locally-delivered training improves outcomes, the RCOG will include attendance at such a course in the curriculum for all trainee obstetricians within the UK. The benefits of this study could be to mothers and babies, as well as the NHS and wider society through reduction in costs associated with additional care and support. There is minimal risk associated with taking part in this study as it only analyses routinely collected data.

Where is the study run from?
1. Southmead Hospital (lead site) (UK)
2. St Michael’s Hospital (UK)
3. Royal United Hospital (UK)
4. Gloucestershire Royal Hospital (UK)

When is the study starting and how long is it expected to run for?
November 2017 to August 2018

Who is funding the study?
The Health Foundation (UK)

Currently there is no training course for obstetricians in operative vaginal birth (OVB) that has shown benefits in patient-related outcomes. The existing Royal College of Obstetricians and Gynaecologists (RCOG) Operative Birth Simulation Training (ROBUST) course is sporadically undertaken by junior trainees in England. This project seeks to implement this training course and compare routinely collected patient outcomes before and after training to establish the patient benefit of simulation training for all practitioners in operative vaginal birth.


Non-randomised; Both; Design type: Process of Care, Management of Care, Cohort study

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

13 Feb 2018

01 Jun 2018

Publications

2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/30940102/ protocol (added 23/11/2020)

Interventional

Intervention Type : Other
Intervention Description : The intervention studied will be the local provision of structured simulation training in operative vaginal birth (the ROBuST course) to trainees in Obstetrics and Gynaecology. The intervention will be delivered by local faculty of senior obstetricians and midwives. The ROBuST course is a one-day course that utilises simulation models to teach the spectrum of operative birth manoeuvres – rotational and non-rotational forceps and vacuum deliveries, as well as techniques for complex Caesarean sections. Follow-up of clinical outcomes will be between 3 months and 9 months after the provision of training, depending on site.


You can take part if:


1. The woman had a birth conducted within a study site during the applicable study time period, by any doctor, trained or untrained2. An operative vaginal birth instrument (forceps or vacuum) was applied to a fetal head3. The woman had a singleton pregnancy




You may not be able to take part if:

Excludes an instrumented Caesarean birth


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Southmead Hospital (lead site)
    North Bristol NHS Trust Southmead Road
    Bristol
    BS10 5NB
  • St. Michael’s Hospital
    University Hospitals Bristol NHS Foundation Trust Southwell Street
    Bristol
    BS2 8EG
  • Royal United Hospital
    Royal United Hospitals Bath NHS Foundation Trust Combe Park
    Bath
    BA1 3NG
  • Gloucestershire Royal Hospital
    Gloucestershire Hospitals NHS Foundation Trust Great Western Road
    Gloucester
    GL1 3NN


The study is sponsored by North Bristol NHS Trust and funded by The Health Foundation; Grant Codes: AIMS 69396.



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?

Read full details

for Trial ID: ISRCTN11760611

Last updated

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

$img.altText
Public Health Agency Northern Ireland
NHS Scotland
Health and Care Rearch Wales