Condition category
Pregnancy and Childbirth
Date applied
05/03/2018
Date assigned
20/04/2018
Last edited
20/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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)

Who is the main contact?
Laura Timlin
laura.timlin@nbt.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Laura Timlin

ORCID ID

Contact details

Stillbirth Research Office
The Chilterns (Women and Children’s Health)
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
+44 (0)117 41 46762
laura.timlin@nbt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

34506

Study information

Scientific title

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

Acronym

STROBE

Study hypothesis

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.

Ethics approval

STROBE is exempt from REC review. HRA approval received 22/11/2017, IRAS 223629

Study design

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

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

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

Intervention

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.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Failure to achieve vaginal birth with the primary chosen instrument; Timepoint(s): 01/06/2018

Secondary outcome measures

1. Use of second instrument to achieve operative vaginal birth (forceps or ventouse)
2. Caesarean section

3. Episiotomy
4. Perineal trauma (1st/2nd/3rd/4th degree tear)
5. Cervical tear requiring suturing
6. General anaesthesia
7. Estimated blood loss (ml)
8. Apgar score at 1, 5 and 10 minutes
9. Umbilical artery pH
10. Shoulder dystocia (Yes/No)
11. Admission to Neonatal Intensive Care Unit (for any reason immediately following birth)
12. Neonatal death within 28 days of birth (for any reason)

All outcome measures are routinely assessed and recorded contemporaneously by the obstetrician performing the attempted operative vaginal birth

Overall trial start date

24/11/2017

Overall trial end date

31/08/2018

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 2400; UK Sample Size: 2400

Participant exclusion criteria

Excludes an instrumented Caesarean birth

Recruitment start date

13/02/2018

Recruitment end date

30/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Trial participating centre

St. Michael’s Hospital
University Hospitals Bristol NHS Foundation Trust Southwell Street
Bristol
BS2 8EG

Trial participating centre

Royal United Hospital
Royal United Hospitals Bath NHS Foundation Trust Combe Park
Bath
BA1 3NG

Trial participating centre

Gloucestershire Royal Hospital
Gloucestershire Hospitals NHS Foundation Trust Great Western Road
Gloucester
GL1 3NN

Sponsor information

Organisation

North Bristol NHS Trust

Sponsor details

Southmead Hospital
Southmead Road
Bristol
BS10 5NB
United Kingdom
+44 (0)117 41 49333
ResearchSponsor@nbt.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

The Health Foundation; Grant Codes: AIMS 69396

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

There are a number of planned publications for high-impact peer reviewed journals throughout the study and within one year of the trial end date:
1. The protocol has been submitted to BMC Pregnancy and Childbirth
2. Analysis of impact of training on outcome measures – to be submitted to BMJ within one year once data analysis is complete (31/08/2017)
3. Analysis of impact of process measures (number of senior trainers and training interventions per site) on clinical outcomes – to be submitted to BMJ Safety and Quality within one year once data analysis is complete (31/08/2017)

The team will also be disseminating the study findings through links with national bodies (for example, the Royal College of Obstetricians and Gynaecologists) and national and international conferences. Planned conferences so far:
1. The International Federation of Gynecology and Obstetrics (FIGO) – abstract submitted

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a publically available repository. A consolidated anonymised raw master dataset generated during the current study will be uploaded to a publicly available repository hosted by the University of Bristol at the end of data analysis (University of Bristol Research Data Repository, www.data.bris.ac.uk). Data will be publicly available for any form of analysis for 20 years after the end of the study. The DOI of this specific data repository will be included in the final results publication.

Intention to publish date

31/08/2018

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes