MOMS: Sleep Disruption in New Mothers: An Intervention Trial

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT01321710
• Collaborator: National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 152
• Location: 1
• Arms: 3
• Duration (Months): 41
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Pregnancy; Postpartum Period; Sleep Disturbance	Behavioral: Sleep hygiene; Behavioral: Dietary information; Drug: Acetaminophen	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 152 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Sleep Disruption in New Parents: An Intervention Trial
• Study Start Date: Dec 1, 2004
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Maternal Sleep Quantity (Objective) [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) [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) [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 Outcome Measures

1. Maternal Sleep Disturbance (Subjective) [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of California	San Francisco	California	United States	94143-0606

Sponsors and Collaborators

• University of California, San Francisco
• National Institute of Nursing Research (NINR)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT01321710
• Other Study ID Numbers: MOMS Sleep; 2R01NR005345
• First Posted: Mar 23, 2011
• Last Update Posted: Feb 29, 2012
• Last Verified: Jan 1, 2012

• Keywords provided by University of California, San Francisco: sleep hygiene; actigraphy; maternal; infant; postpartum period; immunization; acetaminophen
• Additional relevant MeSH terms: Dyssomnias; Parasomnias; Acetaminophen

Study Results

Participant Flow

Arm/Group Title	Dietary Information & Standard Care	Sleep Hygiene & Standard Care	Sleep Hygiene & Acetaminophen
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

Baseline Characteristics

Arm/Group Title	Dietary Information & Standard Care	Sleep Hygiene & Standard Care	Sleep Hygiene & Acetaminophen	Total
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 Participants	50	58	44	152
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	50 100%	58 100%	44 100%	152 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.8 (6.5)	26.4 (6.4)	26.5 (7.1)	26.6 (6.6)
Sex: Female, Male (Count of Participants)
Female	50 100%	58 100%	44 100%	152 100%
Male	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	50 100%	58 100%	44 100%	152 100%

Outcome Measures

1. Primary Outcome

Title	Maternal Sleep Quantity (Objective)
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)

Outcome Measure Data

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
Arm/Group Description	Mothers in this group received dietary information for improving sleep.	Mothers in this group received sleep hygiene information
Measure Participants	32	77
Mean (Standard Deviation) [hours]	6.1 (1.4)	6.6 (1.3)

2. Primary Outcome

Title	Maternal Sleep Quality (Objective)
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)

Outcome Measure Data

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
Arm/Group Description	Mothers in this group received dietary information for improving sleep.	Mothers in this group received sleep hygiene information
Measure Participants	32	77
Mean (Standard Deviation) [percentage of sleep per time in bed]	68 (11)	71 (10)

3. Secondary Outcome

Title	Maternal Sleep Disturbance (Subjective)
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)

Outcome Measure Data

Analysis Population Description

ITT analysis.

Arm/Group Title	Dietary Information	Sleep Hygiene
Arm/Group Description	Mothers in this group received dietary information for improving sleep.	Mothers in this group received sleep hygiene information.
Measure Participants	44	92
Mean (Standard Deviation) [Scores on a scale]	49.9 (17.9)	49.4 (14.6)

4. Secondary Outcome

Title	Maternal Well-being
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)

Outcome Measure Data

Analysis Population Description

ITT analysis.

Arm/Group Title	Dietary Information	Sleep Hygiene
Arm/Group Description	Mothers in this group received dietary information for improving sleep.	Mothers in this group received sleep hygiene information.
Measure Participants	44	91
Mean (Standard Deviation) [Scores on a scale]	13.3 (7.7)	13.0 (7.9)

5. Primary Outcome

Title	Change in Infant Sleep Quantity (Objective)
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

Outcome Measure Data

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
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.
Measure Participants	21	49
Mean (Standard Deviation) [minutes]	47.4 (133.3)	73.1 (151.8)

Adverse Events

Time Frame	4 months
Arm/Group Title	Dietary Information & Standard Care		Sleep Hygiene & Standard Care		Sleep Hygiene & Acetaminophen
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Dietary Information & Standard Care		Sleep Hygiene & Standard Care		Sleep Hygiene & Acetaminophen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/58 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Dietary Information & Standard Care		Sleep Hygiene & Standard Care		Sleep Hygiene & Acetaminophen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/58 (0%)		0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.