Sleep Disruption in New Mothers: An Intervention Trial

University of California, San Francisco152 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

152

Conditions

Pregnancy Postpartum Period Sleep Disturbance

Interventions

Sleep hygieneBEHAVIORAL

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 informationBEHAVIORAL

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.

AcetaminophenDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of California

San Francisco, California, United States

Outcomes

Primary Outcomes

Maternal Sleep Quantity (Objective)

Maternal sleep quantity is defined as total night-time sleep in hours as measured by wrist actigraphy over 3 nights.

Time frame: 1-month postpartum (approximately)

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.

Time frame: 1 month postpartum (approximately)

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.

Time frame: 24 hours before and 24 hours after immunizations at approximately 2 months of age

Secondary Outcomes

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.

Time frame: 1 month postpartum (approximately)

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.

Time frame: 1 month postpartum (approximately)

Data from ClinicalTrials.gov

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