Sleep Disruption in New Mothers: An Intervention Trial

Not Applicable

Completed

• Conditions: Pregnancy; Postpartum Period; Sleep Disturbance
• Interventions: Behavioral: Dietary information; Behavioral: Sleep hygiene; Drug: Acetaminophen

• Registration Number: NCT01321710
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Results First Submitted: 2011-08-22
• Status Verified: 2012-01
• Results First Submitted QC: 2012-01-27
• Last Update Submitted: 2012-01-27
• Results First Posted: 2012-02-29
• Last Update Posted: 2012-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 152

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary information & standard care	Dietary information	Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance. Infants in this arm receive no intervention beyond standard immunization care.
Sleep hygiene & standard care	Sleep hygiene	Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep. Infants in this arm receive standard immunization care.
Sleep hygiene & acetaminophen	Sleep hygiene	Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep. Infants in this arm receive an acetaminophen intervention (12.5mg per kg infant weight, 1 dose 30 minutes prior to immunization and q4-6h thereafter, for a total of 5 doses) to minimize sleep disturbance following immunization.
Sleep hygiene & acetaminophen	Acetaminophen	Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep. Infants in this arm receive an acetaminophen intervention (12.5mg per kg infant weight, 1 dose 30 minutes prior to immunization and q4-6h thereafter, for a total of 5 doses) to minimize sleep disturbance following immunization.

Primary Outcome Measures

Name	Time	Method
Maternal Sleep Quantity (Objective)	1-month postpartum (approximately)	Maternal sleep quantity is defined as total night-time sleep in hours as measured by wrist actigraphy over 3 nights.
Maternal Sleep Quality (Objective)	1 month postpartum (approximately)	Maternal sleep quality is defined as sleep efficiency (percent sleep per time in bed averaged across 3 nights) as measured by wrist actigraphy.
Change in Infant Sleep Quantity (Objective)	24 hours before and 24 hours after immunizations at approximately 2 months of age	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.

Secondary Outcome Measures

Name	Time	Method
Maternal Sleep Disturbance (Subjective)	1 month postpartum (approximately)	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.
Maternal Well-being	1 month postpartum (approximately)	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.

Trial Locations

Locations (1)

University of California; 🇺🇸 San Francisco, California, United States