| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN00522952 |
| Date ISRCTN assigned | 27/03/2008 |
| Local reference number(s) | CZH/4/245 |
| Public title | A cluster randomised trial to investigate the use of a decision aid for the diagnosis of active labour in term pregnancy |
| Scientific title |
|
| Acronym | TELSiS |
| Disease/condition/study domain | Diagnosis of active labour |
| 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. |
| Design/methodology | A cluster randomised controlled trial |
| Research ethics review | Approved by the Multicentre Research Ethics Committee for Scotland B (ref: 05/MRE10/31) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Women who were primiparous, at term, and assessed as low risk |
| Participants - exclusion criteria | 1. Multiparous
2. Pre-term
3. Multiple pregnancy
4. Medical or obstetric complications
5. Under 16 years of age |
| Patient information material |
|
| Anticipated start date | 31/03/2005 |
| Anticipated end date | 30/06/2007 |
| Status of trial | Completed |
| Target number of participants | 4,800 (12 clusters, 400 women in each cluster) |
| Interventions | Diagnosis of active labour using algorithm vs usual care (labour assessment by standard methods) |
| Primary outcome measure(s) | Use of oxytocin for augmentation of labour |
| Secondary outcome measure(s) | 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 |
| Sources of funding | Chief Scientist Office, Health Service Research Committee, Scotland (UK) |
| Sponsor name | University of Stirling (UK) |
| Sponsor details | -
Stirling
United Kingdom
FK9 4LA |
| Sponsor email | carol.johnstone@stir.ac.uk |
| Sponsor website | http://www.external.stir.ac.uk |
| Contact name | Ms Helen Cheyne |
| Contact details | Iris Murdoch Building
University of Stirling
Stirling
United Kingdom
FK9 4LA |
| Contact email | h.l.cheyne@stir.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN00522952 |
| Date last extracted from ISRCTN register | 17/04/2008 |
