Clinical trial NCT01321710: Sleep Disruption in New Mothers: An Intervention Trial
Official title: Sleep Disruption in New Parents: An Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Postpartum Period
Sleep Disturbance
Keywords: sleep hygiene
actigraphy
maternal
infant
postpartum period
immunization
acetaminophen
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2011-03-23
Enrollment: 152
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test a behavioral intervention to minimize sleep disruption and fatigue in new mothers after the birth of their first infant. This study also tests whether an acetaminophen intervention at the time of an infant's 2-month immunization series improves infant and maternal sleep.


Eligibility criteria: Inclusion Criteria:

* pregnant women expecting first singleton birth
* able to speak, read, and write in English
* willing to participate for 3 consecutive days and nights during 36-39 weeks gestation and at 4, 8, and 12 weeks postpartum
* willing to have their infant participate in ankle actigraphy recording of their sleep/wake patterns for 96 hrs at the time of their first immunization

Exclusion Criteria:

* history of affective illness prior to pregnancy
* current use of medications that may alter sleep
* history of a diagnosed sleep disorder such as sleep apnea, nocturnal myoclonus, or narcolepsy
* plan to employ live-in help with child care
* working the night-shift
* multiple pregnancy with twins or more

Primary outcomes:
measure: Maternal Sleep Quantity (Objective)
timeFrame: 1-month postpartum (approximately)
measure: Maternal Sleep Quality (Objective)
timeFrame: 1 month postpartum (approximately)
measure: Change in Infant Sleep Quantity (Objective)
timeFrame: 24 hours before and 24 hours after immunizations at approximately 2 months of age
Secondary outcomes:
measure: Maternal Sleep Disturbance (Subjective)
timeFrame: 1 month postpartum (approximately)
measure: Maternal Well-being
timeFrame: 1 month postpartum (approximately)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, San Francisco
name: Kathryn A. Lee, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee KA, Gay CL. Can modifications to the bedroom environment improve the sleep of new parents? Two randomized controlled trials. Res Nurs Health. 2011 Feb;34(1):7-19. doi: 10.1002/nur.20413. Epub 2010 Nov 17.
citation: Goyal D, Gay C, Lee KA. How much does low socioeconomic status increase the risk of prenatal and postpartum depressive symptoms in first-time mothers? Womens Health Issues. 2010 Mar-Apr;20(2):96-104. doi: 10.1016/j.whi.2009.11.003. Epub 2010 Feb 4.
citation: Kennedy HP, Gardiner A, Gay C, Lee KA. Negotiating sleep: a qualitative study of new mothers. J Perinat Neonatal Nurs. 2007 Apr-Jun;21(2):114-22. doi: 10.1097/01.JPN.0000270628.51122.1d.
citation: Franck L, Gay CL, Lynch M, Lee KA. Infant sleep after immunization: randomized controlled trial of prophylactic acetaminophen. Pediatrics. 2011 Dec;128(6):1100-8. doi: 10.1542/peds.2011-1712. Epub 2011 Nov 28.