Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-59614
Study information
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
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
Ethics approval
The Ethics Review Office of University of Toronto approved on the 4th August 2004
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pregnancy and labour
Intervention
Structured early labour care, defined as: nurses 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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Spontaneous vaginal delivery, as recorded on the medical record.
Secondary outcome measures
1. Labour and birth without use of intrapartum analgesia/anaesthesia
2. Perineal trauma
3. Costs
4. Womens evaluation of their care
Overall trial start date
01/10/2002
Overall trial end date
30/09/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
5000
Participant 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
Recruitment start date
01/10/2002
Recruitment end date
30/09/2006
Locations
Countries of recruitment
Canada
Trial participating centre
155 College Street
Toronto, Ontario
M5T 1P8
Canada
Sponsor information
Organisation
University of Toronto (Canada)
Sponsor details
27 King's College Circle
Toronto
Ontario
M5S 1A1
Canada
research.services@utoronto.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-59614)
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
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18755762
Publication citations
-
Results
Hodnett ED, Stremler R, Willan AR, Weston JA, Lowe NK, Simpson KR, Fraser WD, Gafni A, , Effect on birth outcomes of a formalised approach to care in hospital labour assessment units: international, randomised controlled trial., BMJ, 2008, 337, a1021.