Sleep Disruption in New Mothers: An Intervention Trial (MOMS)
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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 |
- 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.
- 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. 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 |
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| United States, California | |
| University of California | |
| San Francisco, California, United States, 94143-0606 | |
| 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 Nervous System Diseases Neurologic Manifestations Signs and Symptoms Mental Disorders Acetaminophen Antipyretics |
Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013