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

January 27, 2012 updated by: University of California, San Francisco

Sleep Disruption in New Parents: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143-0606
        • University of California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1-month postpartum (approximately)
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.
1 month postpartum (approximately)
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.
24 hours before and 24 hours after immunizations at approximately 2 months of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month postpartum (approximately)
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.
1 month postpartum (approximately)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Kathryn A. Lee, RN, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

March 22, 2011

First Submitted That Met QC Criteria

March 22, 2011

First Posted (Estimate)

March 23, 2011

Study Record Updates

Last Update Posted (Estimate)

February 29, 2012

Last Update Submitted That Met QC Criteria

January 27, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOMS Sleep
  • 2R01NR005345 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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