A cluster randomised trial to investigate the use of a decision aid for the diagnosis of active labour in term pregnancy
ISRCTN | ISRCTN00522952 |
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DOI | https://doi.org/10.1186/ISRCTN00522952 |
Secondary identifying numbers | CZH/4/245 |
- Submission date
- 28/02/2008
- Registration date
- 27/03/2008
- Last edited
- 10/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Helen Cheyne
Scientific
Scientific
Iris Murdoch Building
University of Stirling
Stirling
FK9 4LA
United Kingdom
h.l.cheyne@stir.ac.uk |
Study information
Study design | A cluster randomised controlled trial |
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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 |
Eligibility
Participant type(s) | Patient |
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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 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Iris Murdoch Building
Stirling
FK9 4LA
United Kingdom
FK9 4LA
United Kingdom
Sponsor information
University of Stirling (UK)
University/education
University/education
-
Stirling
FK9 4LA
Scotland
United Kingdom
carol.johnstone@stir.ac.uk | |
Website | http://www.external.stir.ac.uk |
https://ror.org/045wgfr59 |
Funders
Funder type
Government
Chief Scientist Office, Health Service Research Committee, Scotland (UK)
No information available
Results and Publications
Intention to publish date | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 08/12/2008 | Yes | No |