Condition category
Pregnancy and Childbirth
Date applied
01/09/2005
Date assigned
01/09/2005
Last edited
23/02/2009
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

Prof Ellen D. Hodnett

ORCID ID

Contact details

155 College Street
Suite 215
Toronto
Ontario
M5T 1P8
Canada

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: 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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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. Women’s evaluation of their care

Overall trial start date

01/10/2002

Overall trial end date

30/09/2006

Reason abandoned

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

http://www.utoronto.ca/

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18755762

Publication citations

  1. 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.

Additional files

Editorial Notes