Condition category
Nervous System Diseases
Date applied
03/07/2008
Date assigned
03/07/2008
Last edited
28/05/2013
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

Dr Robyn Stremler

ORCID ID

Contact details

Faculty of Nursing
University of Toronto
Room 288
155 College Street
Toronto
M5T 1P8
Canada
+1 416 978 6925
robyn.stremler@utoronto.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-84658

Study information

Scientific title

Tips for Infant and Parent Sleep: a randomised, blinded, parallel assignment trial

Acronym

TIPS

Study hypothesis

Primary question:
Compared to usual care, what is the effect of a behavioural-educational sleep intervention in the early postpartum on maternal nocturnal sleep?

Secondary question:
Compared to usual care, what is the effect of a behavioural-educational sleep intervention in the early postpartum on length of an infant's longest nocturnal sleep period?

Additional research questions will address the effects of a behavioural-educational sleep intervention in the early postpartum on: maternal nighttime awakenings, infant nighttime awakenings, maternal sleep disturbance, depressive symptomatology, maternal morning fatigue, and breastfeeding.

Please note that as of 04/03/2009 the anticipated end date in this record was amended; the previous date was as follows:
Initial anticipated end date: 01/12/2008

Ethics approval

Ethics committees of:
1. Sunnybrook Health Sciences Centre, Toronto approved on the 27th November 2007
2. St Michael's Hospital, Toronto approved on the 4th February 2008
3. University of Toronto approved on the 9th March 2007

Study design

Randomised, blinded (investigator, data analyst, research nurse), parallel assignment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Sleep disorders

Intervention

Experimental:
TIPS (45-minute behavioural-educational session with a Research Nurse [RN] in hospital, 20-page booklet, 3 phone calls at home in the postpartum).

Control:
Usual care (three phone calls at home to provide attention only).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Maternal nocturnal (9 pm - 9 am) sleep (in minutes) as measured at 6 and 12 weeks postpartum.

Secondary outcome measures

Infant's longest nocturnal (9 pm - 9 am) sleep period (in minutes) as measured at 6 and 12 weeks postpartum.

Overall trial start date

30/05/2008

Overall trial end date

15/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women (single or partnered), no age limit
2. Have given birth for the first time
3. Have a singleton baby born at gestational age (GA) greater than or equal to 37 weeks
4. Have a baby described as healthy in the newborn examination
5. Live in the greater Toronto area
6. Plan to provide full time infant care for at least the first 12 weeks after birth
7. Women with previous miscarriages at less than 20 weeks GA are eligible if the most recent pregnancy resulted in a first child

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

234

Participant exclusion criteria

1. Women or women whose partners have experienced stillbirth or perinatal death at greater than or equal to 20 weeks GA
2. Women whose partners have children from another relationship
3. Maternal or infant complications requiring prolonged hospital stay
4. Maternal chronic illness that is poorly controlled
5. Maternal use of medications that affect sleep (e.g. benzodiazepines)
6. Maternal (or partner, if they exist) drug or alcohol use beyond social use
7. Women (or partners, if one exists) with a diagnosed sleep disorder (e.g. sleep apnoea, narcolepsy)
8. Mother's partner, if one exists, is working night shifts
9. Mother unable to read or understand English
10. No telephone in the home
11. Involvement in another research study involving sleep

Recruitment start date

30/05/2008

Recruitment end date

15/04/2009

Locations

Countries of recruitment

Canada

Trial participating centre

Faculty of Nursing
Toronto
M5T 1P8
Canada

Sponsor information

Organisation

University of Toronto (Canada)

Sponsor details

27 King's College Circle
Toronto
M5S 1A1
Canada

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-84658)

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

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23516146

Publication citations

  1. Results

    Stremler R, Hodnett E, Kenton L, Lee K, Weiss S, Weston J, Willan A, Effect of behavioural-educational intervention on sleep for primiparous women and their infants in early postpartum: multisite randomised controlled trial., BMJ, 2013, 346, f1164.

Additional files

Editorial Notes