title: Effect of behavioural-educational intervention on sleep for primiparous women and their infants in early postpartum: multisite randomised controlled trial.
abstract: OBJECTIVE
  To evaluate the effectiveness of a behavioural-educational sleep intervention delivered in the early postpartum in improving maternal and infant sleep.
  
  
  METHODS
  Randomised controlled trial.
  
  
  METHODS
  Postpartum units of two university affiliated hospitals.
  
  
  METHODS
  246 primiparous women and their infants randomised while in hospital with an internet based randomisation service to intervention (n=123) or usual care (n=123) groups.
  
  
  METHODS
  The behavioural-educational sleep intervention included a 45-60 minute meeting with a nurse to discuss sleep information and strategies to promote maternal and infant sleep, a 20 page booklet with the content discussed, and phone contacts at one, two, and four weeks postpartum to reinforce information, provide support, and problem solve. The usual care group received calls at weeks one, two, and four to maintain contact without provision of advice.
  
  
  METHODS
  Primary outcome was maternal nocturnal (9 pm to 9 am) sleep (minutes) and secondary outcome was longest stretch of infant nocturnal sleep (minutes) measured at six and 12 weeks postpartum by actigraphy. Other outcomes measured at six and 12 weeks were number of maternal and infant night time awakenings by actigraphy, fatigue visual analogue scale, general sleep disturbance scale, and Edinburgh postnatal depression scale. Rates of exclusive breast feeding were measured at 12 weeks postpartum only.
  
  
  RESULTS
  All women who completed any outcome measures at six or 12 weeks were included in analysis. Sleep outcomes were completed at one or both of six and 12 weeks postpartum for 215 of 246 (87%) women (110/123 intervention and 105/123 usual care). Longitudinal mixed effects model analyses indicated no significant differences between the groups on any of the outcomes. The estimated mean difference in maternal nocturnal sleep between the intervention and usual care groups was 5.97 minutes (95% confidence interval -7.55 to 19.5 minutes, P=0.39). No differences in any outcomes were noted based on the specific nurse delivering the intervention or the number of phone contacts received.
  
  
  CONCLUSIONS
  A behavioural-educational intervention delivered in the early postpartum, in hospital, and in the first weeks at home, was ineffective in improving maternal and infant sleep or other health outcomes in the first months postpartum.
  
  
  BACKGROUND
  ISRCT No 13501166.
authors.affiliation: Lawrence S Bloomberg Faculty of Nursing, University of Toronto, Toronto, ON, Canada. robyn.stremler@utoronto.ca
authors.forename: Robyn
authors.initials: R
authors.lastname: Stremler
authors.forename: Ellen
authors.initials: E
authors.lastname: Hodnett
authors.forename: Laura
authors.initials: L
authors.lastname: Kenton
authors.forename: Kathryn
authors.initials: K
authors.lastname: Lee
authors.forename: Shelly
authors.initials: S
authors.lastname: Weiss
authors.forename: Julie
authors.initials: J
authors.lastname: Weston
authors.forename: Andrew
authors.initials: A
authors.lastname: Willan
mesh_terms: D000328:Adult; D001521:Behavior Therapy / Q000379:methods; D001942:Breast Feeding; D019052:Depression, Postpartum / Q000517:prevention & control; D005260:Female; D005500:Follow-Up Studies; D020073:Gravidity; D006293:Health Promotion; D006785:Hospitals, University; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D009864:Ontario; D049590:Postpartum Period; D011247:Pregnancy; D012890:Sleep; D012893:Sleep Wake Disorders / Q000517:prevention & control; D011795:Surveys and Questionnaires; D016896:Treatment Outcome