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

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ClinicalTrials.gov Identifier: NCT01321710
Recruitment Status : Completed
First Posted : March 23, 2011
Results First Posted : February 29, 2012
Last Update Posted : February 29, 2012
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Pregnancy
Postpartum Period
Sleep Disturbance
Interventions Behavioral: Sleep hygiene
Behavioral: Dietary information
Drug: Acetaminophen
Enrollment 152

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dietary Information & Standard Care Sleep Hygiene & Standard Care Sleep Hygiene & Acetaminophen
Hide Arm/Group Description

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

Infants in this arm receive standard immunization care.

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

Infants in this arm receive standard immunization care.

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

Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization.

Period Title: Overall Study
Started 50 58 44
Completed 46 53 44
Not Completed 4 5 0
Reason Not Completed
Lost to Follow-up             4             5             0
Arm/Group Title Dietary Information & Standard Care Sleep Hygiene & Standard Care Sleep Hygiene & Acetaminophen Total
Hide Arm/Group Description

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

Infants in this arm receive standard immunization care.

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

Infants in this arm receive standard immunization care.

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

Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization.

Total of all reporting groups
Overall Number of Baseline Participants 50 58 44 152
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 58 participants 44 participants 152 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
50
 100.0%
58
 100.0%
44
 100.0%
152
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 58 participants 44 participants 152 participants
26.8  (6.5) 26.4  (6.4) 26.5  (7.1) 26.6  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 58 participants 44 participants 152 participants
Female
50
 100.0%
58
 100.0%
44
 100.0%
152
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 58 participants 44 participants 152 participants
50 58 44 152
1.Primary Outcome
Title Maternal Sleep Quantity (Objective)
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis. Because this was a repeated measures analysis at 1 and 3 months postpartum, subjects missing outcome data at either point were excluded from the analysis.
Arm/Group Title Dietary Information Sleep Hygiene
Hide Arm/Group Description:
Mothers in this group received dietary information for improving sleep.
Mothers in this group received sleep hygiene information
Overall Number of Participants Analyzed 32 77
Mean (Standard Deviation)
Unit of Measure: hours
6.1  (1.4) 6.6  (1.3)
2.Primary Outcome
Title Maternal Sleep Quality (Objective)
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis. Because this was a repeated measures analysis at 1 and 3 months postpartum, subjects missing outcome data at either point were excluded from the analysis.
Arm/Group Title Dietary Information Sleep Hygiene
Hide Arm/Group Description:
Mothers in this group received dietary information for improving sleep.
Mothers in this group received sleep hygiene information
Overall Number of Participants Analyzed 32 77
Mean (Standard Deviation)
Unit of Measure: percentage of sleep per time in bed
68  (11) 71  (10)
3.Primary Outcome
Title Change in Infant Sleep Quantity (Objective)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis. Infants who were not immunized or did not have valid outcome data were excluded from the analysis.
Arm/Group Title Standard Immunization Care Prophylactic Acetaminophen
Hide Arm/Group Description:
Infants in this group received standard immunization care from their health care provider (may or may not have included prophylactic acetaminophen).
Infants in this group received prophylactic acetaminophen administered prior to immunization and 4 subsequent doses administered in the 24 hours following immunization.
Overall Number of Participants Analyzed 21 49
Mean (Standard Deviation)
Unit of Measure: minutes
47.4  (133.3) 73.1  (151.8)
4.Secondary Outcome
Title Maternal Sleep Disturbance (Subjective)
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis.
Arm/Group Title Dietary Information Sleep Hygiene
Hide Arm/Group Description:
Mothers in this group received dietary information for improving sleep.
Mothers in this group received sleep hygiene information.
Overall Number of Participants Analyzed 44 92
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
49.9  (17.9) 49.4  (14.6)
5.Secondary Outcome
Title Maternal Well-being
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis.
Arm/Group Title Dietary Information Sleep Hygiene
Hide Arm/Group Description:
Mothers in this group received dietary information for improving sleep.
Mothers in this group received sleep hygiene information.
Overall Number of Participants Analyzed 44 91
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
13.3  (7.7) 13.0  (7.9)
Time Frame 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dietary Information & Standard Care Sleep Hygiene & Standard Care Sleep Hygiene & Acetaminophen
Hide Arm/Group Description

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

Infants in this arm receive standard immunization care.

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

Infants in this arm receive standard immunization care.

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

Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization.

All-Cause Mortality
Dietary Information & Standard Care Sleep Hygiene & Standard Care Sleep Hygiene & Acetaminophen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dietary Information & Standard Care Sleep Hygiene & Standard Care Sleep Hygiene & Acetaminophen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/44 (0.00%)   0/58 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Dietary Information & Standard Care Sleep Hygiene & Standard Care Sleep Hygiene & Acetaminophen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/44 (0.00%)   0/58 (0.00%)   0/50 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Kathryn Lee, RN, PhD
Organization: University of California, San Francisco
Phone: 415-476-4442
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01321710     History of Changes
Other Study ID Numbers: MOMS Sleep
2R01NR005345 ( U.S. NIH Grant/Contract )
First Submitted: March 22, 2011
First Posted: March 23, 2011
Results First Submitted: August 22, 2011
Results First Posted: February 29, 2012
Last Update Posted: February 29, 2012