Sleep Disruption in New Mothers: An Intervention Trial

Pregnancy Clinical Trial

— MOMS  

Official title:

Sleep Disruption in New Parents: An Intervention Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321710
• Other study ID #: MOMS Sleep
• Secondary ID: 2R01NR005345
• Status: Completed
• Phase: N/A
• First received: March 22, 2011
• Last updated: January 27, 2012
• Start date: December 2004
• Est. completion date: May 2008

Study information

• Verified date: January 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Postpartum Period
• Pregnancy
• Sleep Disorders
• Sleep Disturbance

Intervention

Behavioral:
• Sleep hygiene
This intervention consists of behavioral strategies for minimizing maternal arousal and sleep disturbance as a result of night-time infant care. Key components include: infant proximity, low lighting, and noise attenuation. It is administered to women during their last month of pregnancy.
• Dietary information
This intervention consists of dietary information aimed at improving postpartum sleep. The recommendations include avoiding alcohol, caffeine, and heavy meals before bed, as well as eating healthy foods.

Drug:
• Acetaminophen
51-90mg depending on infant weight (12.5mg per kg infant weight). Administered 30 minutes prior to immunization and q4-6h for a total of 5 doses.

Locations

Country	Name	City	State
United States	University of California	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal Sleep Quantity (Objective)	Maternal sleep quantity is defined as total night-time sleep in hours as measured by wrist actigraphy over 3 nights.	1-month postpartum (approximately)	No
Primary	Maternal Sleep Quality (Objective)	Maternal sleep quality is defined as sleep efficiency (percent sleep per time in bed averaged across 3 nights) as measured by wrist actigraphy.	1 month postpartum (approximately)	No
Primary	Change in Infant Sleep Quantity (Objective)	Change in infant sleep quantity is defined as the difference between the number of hours slept in the 24 hours prior to immunization and the the number of hours slept after immunization (positive numbers indicate more sleep following immunization). Infant sleep was measured by ankle actigraphy.	24 hours before and 24 hours after immunizations at approximately 2 months of age	No
Secondary	Maternal Sleep Disturbance (Subjective)	Maternal sleep disturbance is measured by the total score on the General Sleep Disturbance Scale (GSDS). The GSDS is a self-report questionnaire that measures perceived sleep disturbance in the past week. GSDS scores range from 0 to 147, with higher scores indicating more sleep disturbance.	1 month postpartum (approximately)	No
Secondary	Maternal Well-being	Maternal well-being was measured by the total score on the Center for Epidemiologic Studies - Depression Scale (CES-D). The CES-D measures depressive symptoms in the past week. CES-D scores can range 0 to 60, with higher scores indicating more symptoms of depression.	1 month postpartum (approximately)	No