SELAN Trial: Structured Early Labour Assessment and care by Nurses

ISRCTN	ISRCTN16315180
DOI	https://doi.org/10.1186/ISRCTN16315180
Secondary identifying numbers	MCT-59614

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Ellen D. Hodnett
Scientific

155 College Street
Suite 215
Toronto, Ontario
M5T 1P8
Canada

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	The effectiveness of a structured approach to assessment and care by nurses in early or latent phase labour: a randomised controlled trial
Study acronym	SELAN
Study objectives	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(s)	The Ethics Review Office of University of Toronto approved on the 4th August 2004
Health condition(s) or problem(s) studied	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
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 study start date	01/10/2002
Completion date	30/09/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	5000
Key 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
Key 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
Date of first enrolment	01/10/2002
Date of final enrolment	30/09/2006

155 College Street

Toronto, Ontario
M5T 1P8
Canada

University of Toronto (Canada)
University/education

27 King's College Circle
Toronto, Ontario
M5S 1A1
Canada

Email	research.services@utoronto.ca
Website	http://www.utoronto.ca/
"ROR"	https://ror.org/03dbr7087

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-59614)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/08/2008		Yes	No