Condition category
Pregnancy and Childbirth
Date applied
30/07/2013
Date assigned
09/09/2013
Last edited
09/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Safety in labour is a priority for women, their families, staff and the NHS, but unfortunately UK maternity care is not as safe as it could and should be. Over 50% of adverse pregnancy outcomes in the UK could be prevented with better care during childbirth (intrapartum care). These failings have significant impact on both families and the NHS. Training for emergencies during childbirth has been recommended almost annually since 1999. A local, multi-professional and inexpensive intrapartum emergencies training course was developed in Bristol, where its implementation was associated with sustained local improvements in a number of clinically important outcomes. The aim of the study is to determine if a multi-professional training programme for local maternity staff (PROMPT) is clinically effective across a health service.

Who can participate?
The study population consists of the 15 Scottish maternity units with more than 1000 births per year.

What does the study involve?
The study is a training programme for intrapartum emergencies. It provides the tools for designated in-house trainers to give multi-professional training for intrapartum emergencies for all maternity workers in their own units. Participating units will identify four multi-professional in-house trainers (two midwives, one obstetrician and one anaesthetist) to attend the two-day PROMPT Train-the-Trainers (T3), which comprises a demonstration PROMPT Course and a Train-the-Trainers (T3) day (lectures and workshops for electronic monitoring of the unborn baby and simulated emergency scenarios) to guide in-house trainers in how to set up training in their local unit. Telephone and email support is also provided by the PROMPT team to each participating unit after attending their T3 training. After participating in the two-day PROMPT T3 programme, in-house trainers will be given time to set up and start the in-house PROMPT courses locally. They should aim to have trained all maternity staff in their unit within a year of starting training.

What are the possible benefits and risks of participating?
This intervention programme can improve compliance with clinical standards and lead to a reduction in clinical error. We do not believe there are any disadvantages or risks to participating in this study.

Where is the study run from?
University of Aberdeen in collaboration with PROMPT Maternity Foundation, Bristol, UK.

When is study starting and how long is it expected to run for?
Recruitment will start in late 2013 and the funding will end in late 2016.

Who is funding the study?
Chief Scientist Office, Scotland, UK

Who is the main contact?
The co-ordinating trial office - Centre for Healthcare Randomised Trials
chart@abdn.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Siladitya Bhattacharya

ORCID ID

Contact details

Institute of Applied Health Sciences
School of Medicine and Dentistry
University of Aberdeen
Aberdeen Maternity Hospital
Foresterhill
Aberdeen AB25 2ZD
ABERDEEN
AB25 2ZD
United Kingdom
s.bhattacharya@abdn.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CZH/4/893

Study information

Scientific title

Trial of Hands-on Interprofessional Simulation Training for Local Emergencies: a stepped-wedge clustered randomised controlled trial

Acronym

THISTLE

Study hypothesis

Does the implementation of an intrapartum emergencies training package across a health service reduce the rate of Apgar <7 at 5 minutes, in term babies (excluding elective caesarean births)?

Ethics approval

Ethics approval to be applied for 1/8/13 via proprotionate review with North of Scotland Research Ethics Committee (NoSRES)

Study design

Stepped-wedge clustered randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

Perinatal outcomes

Intervention

The intervention is the 2 day PROMPT Train the Trainers (T3) programme; including a demonstration PROMPT course, a Train-The-Trainers (T3) day and local use of the PROMPT Course-in-a-box (Second edition). Four multi-professional in-house trainers from each unit will undertake the 2 day PROMPT T3 programme and then run in-house PROMPT courses locally for all maternity staff in their unit.

The 2 day PROMPT T3 programme will be performed in collaboration with Scottish Core Obstetric Teaching and Training in Emergencies (SCOTTIE).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

proportion of infants born with a low Apgar score (score < 7 vs. ≥7) at 5 minutes for each vaginal or emergency CS term birth (≥37weeks).

Secondary outcome measures

1. Descriptive data from the units will be collated:
1.1. Total number of births per annum
1.2. Total number of staff in the unit – separated into staff groups
1.3. Total number of staff trained – separated into staff groups
2. Process measures: % of staff trained and time to train local staff.

Overall trial start date

01/08/2013

Overall trial end date

31/08/2016

Reason abandoned

Eligibility

Participant inclusion criteria

The study population will consist of the 15 Scottish maternity units with more than 1000 births per year. Participating units which have not previously undertaken PROMPT training (n=12) will be randomised and be part of the main analysis.

The three units which have already undertaken PROMPT training will not be randomised but will be included in complementary analyses. Their inclusion will allow us to assess the intervention effect at country scale, whilst giving us insight into the long-term sustainability of the intervention effect.

Participant type

Patient

Age group

Other

Gender

Not Specified

Target number of participants

15 Scottish Maternity units

Participant exclusion criteria

Scottish maternity units or midwifery units with less than 1000 births per year are ineligible for recruitment.

Recruitment start date

01/08/2013

Recruitment end date

31/08/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Applied Health Sciences
ABERDEEN
AB25 2ZD
United Kingdom

Sponsor information

Organisation

University of Aberdeen (UK)

Sponsor details

Research and Innovation
Kings College
Regent Walk
Aberdeen
AB24 3FX
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Chief Scientist Office, UK - CZH/4/893

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes