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SELAN Trial: Structured Early Labour Assessment and care by Nurses
ISRCTN ISRCTN16315180
DOI 10.1186/ISRCTN16315180
ClinicalTrials.gov identifier
EudraCT number
Public title SELAN Trial: Structured Early Labour Assessment and care by Nurses
Scientific title The effectiveness of a structured approach to assessment and care by nurses in early or latent phase labour: a randomised controlled trial
Acronym SELAN
Serial number at source MCT-59614
Study hypothesis 1. To evaluate the effectiveness of structured approach to assessment and care by nurses in early or latent phase labour
2. To compare the costs of the new approach to the costs of usual care
Lay summary
Ethics approval The Ethics Review Office of University of Toronto approved on the 4th August 2004
Study design Randomised controlled trial
Countries of recruitment Canada
Disease/condition/study domain Pregnancy and labour
Participants - inclusion criteria 1. Nulliparous, live singleton foetus in cephalic position
2. Mothers aged 18 - 49 years old
3. No contraindications to labour
4. Competent to give informed consent or has a parent/guardian who is competent to give informed consent
5. Experiencing contractions but does not meet criteria for admission to labour and delivery unit
Participants - exclusion criteria 1. Gestational age less than 34 weeks
2. Planned caesarean delivery
3. Undergoing or admitted for cervical ripening or induction of labour
4. Complications that necessitate admission to antepartum unit or labour and delivery unit
5. Likely to be transferred to labour and delivery with one hour
6. Has a doula or midwife providing continuous support
7. Already enrolled in labour/delivery management study and the study protocols are incompatible
Anticipated start date 01/10/2002
Anticipated end date 30/09/2006
Status of trial Completed
Patient information material
Target number of participants 5000
Interventions Structured early labour care, defined as: nurse’s assessment of foetal position, emotional status, and pain, followed by individualised interventions, including: positioning techniques, cognitive-behavioural strategies, comfort measures, and anticipatory guidance.
Control: usual care.
Primary outcome measure(s) Spontaneous vaginal delivery, as recorded on the medical record.
Secondary outcome measure(s) 1. Labour and birth without use of intrapartum analgesia/anaesthesia
2. Perineal trauma
3. Costs
4. Women’s evaluation of their care
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-59614)
Trial website
Publications 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18755762
Contact name Prof  Ellen D.  Hodnett
  Address 155 College Street
Suite 215
  City/town Toronto, Ontario
  Zip/Postcode M5T 1P8
  Country Canada
Sponsor University of Toronto (Canada)
  Address 27 King's College Circle
  City/town Toronto, Ontario
  Zip/Postcode M5S 1A1
  Country Canada
  Email research.services@utoronto.ca
  Sponsor website: http://www.utoronto.ca/
Date applied 01/09/2005
Last edited 23/02/2009
Date ISRCTN assigned 01/09/2005
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