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
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

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

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

Study information

Study designA cluster randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeDiagnostic
Scientific title
Study acronymTELSiS
Study objectivesThe 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) studiedDiagnosis of active labour
InterventionDiagnosis of active labour using algorithm vs usual care (labour assessment by standard methods)
Intervention typeOther
Primary outcome measureUse of oxytocin for augmentation of labour
Secondary outcome measures1. 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 date31/03/2005
Completion date30/06/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants4,800 (12 clusters, 400 women in each cluster)
Key inclusion criteriaWomen who were primiparous, at term, and assessed as low risk
Key exclusion criteria1. Multiparous
2. Pre-term
3. Multiple pregnancy
4. Medical or obstetric complications
5. Under 16 years of age
Date of first enrolment31/03/2005
Date of final enrolment30/06/2007

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Iris Murdoch Building
Stirling
FK9 4LA
United Kingdom

Sponsor information

University of Stirling (UK)
University/education

-
Stirling
FK9 4LA
Scotland
United Kingdom

Email carol.johnstone@stir.ac.uk
Website http://www.external.stir.ac.uk
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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