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Completed

NCT Number: NCT01321710

Sleep Disruption in New Mothers: An Intervention Trial

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.

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Key information

Conditions

Pregnancy Behavior Health Behavior Mental Disorders Nervous System Diseases Parasomnias Postpartum Period Sleep Disturbance Sleep Hygiene Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California

San Francisco, California, 94143-0606, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Hygiene

Behavioral

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

Behavioral

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.

Acetaminophen

Drug

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.

Primary outcomes

  1. Maternal Sleep Quantity (Objective)

    Time frame: 1-month postpartum (approximately)

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

  2. Maternal Sleep Quality (Objective)

    Time frame: 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.

  3. Change in Infant Sleep Quantity (Objective)

    Time frame: 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 outcomes

  1. Maternal Sleep Disturbance (Subjective)

    Time frame: 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.

  2. Maternal Well-being

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Sleep Disruption in New Parents: An Intervention Trial

Acronym: MOMS

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Mar 23, 2011
Registry last updated
Feb 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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