A cluster randomised trial to investigate the use of a decision aid for the diagnosis of active labour in term pregnancy

ISRCTN	ISRCTN00522952
DOI	https://doi.org/10.1186/ISRCTN00522952
Secondary identifying numbers	CZH/4/245

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Ms Helen Cheyne
Scientific

Iris Murdoch Building
University of Stirling
Stirling
FK9 4LA
United Kingdom

Email	h.l.cheyne@stir.ac.uk

Study design	A cluster randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Diagnostic
Scientific title
Study acronym	TELSiS
Study objectives	The primary aim of this study is to compare the effectiveness of a decision aid for diagnosis of active labour, with standard care in terms of maternal and neonatal outcomes, costs and costs savings. A secondary aim is to explore the impact of the intervention on women.
Ethics approval(s)	Approved by the Multicentre Research Ethics Committee for Scotland B (ref: 05/MRE10/31)
Health condition(s) or problem(s) studied	Diagnosis of active labour
Intervention	Diagnosis of active labour using algorithm vs usual care (labour assessment by standard methods)
Intervention type	Other
Primary outcome measure	Use of oxytocin for augmentation of labour
Secondary outcome measures	1. Interventions in labour i.e. artificial rupture of membranes (ARM) 2. Vaginal examination (VE) 3. Use of analgesia 4. Mode of delivery 5. Management of women "not in labour" 6. Intrapartum complications 7. Neonatal outcome 8. Unplanned out-of-hospital births 9. NHS cost and cost to women
Overall study start date	31/03/2005
Completion date	30/06/2007

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	4,800 (12 clusters, 400 women in each cluster)
Key inclusion criteria	Women who were primiparous, at term, and assessed as low risk
Key exclusion criteria	1. Multiparous 2. Pre-term 3. Multiple pregnancy 4. Medical or obstetric complications 5. Under 16 years of age
Date of first enrolment	31/03/2005
Date of final enrolment	30/06/2007

Iris Murdoch Building

Stirling
FK9 4LA
United Kingdom

University of Stirling (UK)
University/education

-
Stirling
FK9 4LA
Scotland
United Kingdom

Government

Chief Scientist Office, Health Service Research Committee, Scotland (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	08/12/2008		Yes	No