Sleep Disruption in New Mothers: An Intervention Trial (MOMS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01321710
First received: March 22, 2011
Last updated: January 27, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Pregnancy
Postpartum Period
Sleep Disturbance
Behavioral: Sleep hygiene
Behavioral: Dietary information
Drug: Acetaminophen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Sleep Disruption in New Parents: An Intervention Trial

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Maternal Sleep Quantity (Objective) [ Time Frame: 1-month postpartum (approximately) ] [ Designated as safety issue: No ]
    Maternal sleep quantity is defined as total night-time sleep in hours as measured by wrist actigraphy over 3 nights.

  • Maternal Sleep Quality (Objective) [ Time Frame: 1 month postpartum (approximately) ] [ Designated as safety issue: No ]
    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) [ Time Frame: 24 hours before and 24 hours after immunizations at approximately 2 months of age ] [ Designated as safety issue: No ]
    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:
  • Maternal Sleep Disturbance (Subjective) [ Time Frame: 1 month postpartum (approximately) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month postpartum (approximately) ] [ Designated as safety issue: No ]
    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.


Enrollment: 152
Study Start Date: December 2004
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dietary information & standard care

Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.

Infants in this arm receive no intervention beyond standard immunization care.

Behavioral: 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.
Experimental: Sleep hygiene & standard care

Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.

Infants in this arm receive standard immunization care.

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.

Experimental: Sleep hygiene & 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.

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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321710

Locations
United States, California
University of California
San Francisco, California, United States, 94143-0606
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Kathryn A. Lee, RN, PhD University of California, San Francisco
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01321710     History of Changes
Other Study ID Numbers: MOMS Sleep, 2R01NR005345
Study First Received: March 22, 2011
Results First Received: August 22, 2011
Last Updated: January 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
sleep hygiene
actigraphy
maternal
infant
postpartum period
immunization
acetaminophen

Additional relevant MeSH terms:
Sleep Disorders
Dyssomnias
Parasomnias
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Analgesics
Analgesics, Non-Narcotic
Antipyretics
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014