Contact information
Type
Scientific
Primary contact
Ms Helen Cheyne
ORCID ID
Contact details
Iris Murdoch Building
University of Stirling
Stirling
FK9 4LA
United Kingdom
h.l.cheyne@stir.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CZH/4/245
Study information
Scientific title
Acronym
TELSiS
Study hypothesis
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
Approved by the Multicentre Research Ethics Committee for Scotland B (ref: 05/MRE10/31)
Study design
A cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Diagnostic
Patient information sheet
Condition
Diagnosis of active labour
Intervention
Diagnosis of active labour using algorithm vs usual care (labour assessment by standard methods)
Intervention type
Other
Phase
Not Specified
Drug names
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 trial start date
31/03/2005
Overall trial end date
30/06/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Women who were primiparous, at term, and assessed as low risk
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
4,800 (12 clusters, 400 women in each cluster)
Participant exclusion criteria
1. Multiparous
2. Pre-term
3. Multiple pregnancy
4. Medical or obstetric complications
5. Under 16 years of age
Recruitment start date
31/03/2005
Recruitment end date
30/06/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Iris Murdoch Building
Stirling
FK9 4LA
United Kingdom
Sponsor information
Organisation
University of Stirling (UK)
Sponsor details
-
Stirling
FK9 4LA
United Kingdom
carol.johnstone@stir.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office, Health Service Research Committee, Scotland (UK)
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
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19064606
Publication citations
-
Results
Cheyne H, Hundley V, Dowding D, Bland JM, McNamee P, Greer I, Styles M, Barnett CA, Scotland G, Niven C, Effects of algorithm for diagnosis of active labour: cluster randomised trial., BMJ, 2008, 337, a2396.