Condition category
Pregnancy and Childbirth
Date applied
28/02/2008
Date assigned
27/03/2008
Last edited
10/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.external.stir.ac.uk

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19064606

Publication citations

  1. 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.

Additional files

Editorial Notes