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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:

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

Interventional

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
  

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

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