Postpartum Period, Pregnancy, Sleep Disturbance
Conditions
Keywords
sleep hygiene, actigraphy, maternal, infant, postpartum period, immunization, acetaminophen
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.
Interventions
BEHAVIORALSleep 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.
BEHAVIORALDietary 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.
DRUGAcetaminophen
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.
Sponsors
National Institute of Nursing Research (NINR)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dietary Information & Standard Care Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.
Infants in this arm receive standard immunization care. | 50 |
| 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. | 58 |
| 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 to minimize sleep disturbance following immunization. | 44 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 5 | 0 |
Baseline characteristics
| Characteristic | Sleep Hygiene & Standard Care | Sleep Hygiene & Acetaminophen | Dietary Information & Standard Care | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 44 Participants | 50 Participants | 152 Participants |
| Age Continuous | 26.4 years STANDARD_DEVIATION 6.4 | 26.5 years STANDARD_DEVIATION 7.1 | 26.8 years STANDARD_DEVIATION 6.5 | 26.6 years STANDARD_DEVIATION 6.6 |
| Region of Enrollment United States | 58 participants | 44 participants | 50 participants | 152 participants |
| Sex: Female, Male Female | 58 Participants | 44 Participants | 50 Participants | 152 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 44 | 0 / 58 | 0 / 50 |
| serious Total, serious adverse events | 0 / 44 | 0 / 58 | 0 / 50 |
Outcome results
Primary
Change in Infant Sleep Quantity (Objective)
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
Population: ITT analysis. Infants who were not immunized or did not have valid outcome data were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Information | Change in Infant Sleep Quantity (Objective) | 47.4 minutes | Standard Deviation 133.3 |
| Sleep Hygiene | Change in Infant Sleep Quantity (Objective) | 73.1 minutes | Standard Deviation 151.8 |
Primary
Maternal Sleep Quality (Objective)
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)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Information | Maternal Sleep Quality (Objective) | 68 percentage of sleep per time in bed | Standard Deviation 11 |
| Sleep Hygiene | Maternal Sleep Quality (Objective) | 71 percentage of sleep per time in bed | Standard Deviation 10 |
Primary
Maternal Sleep Quantity (Objective)
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)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Information | Maternal Sleep Quantity (Objective) | 6.1 hours | Standard Deviation 1.4 |
| Sleep Hygiene | Maternal Sleep Quantity (Objective) | 6.6 hours | Standard Deviation 1.3 |
Secondary
Maternal Sleep Disturbance (Subjective)
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)
Population: ITT analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Information | Maternal Sleep Disturbance (Subjective) | 49.9 Scores on a scale | Standard Deviation 17.9 |
| Sleep Hygiene | Maternal Sleep Disturbance (Subjective) | 49.4 Scores on a scale | Standard Deviation 14.6 |
Secondary
Maternal Well-being
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)
Population: ITT analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Information | Maternal Well-being | 13.3 Scores on a scale | Standard Deviation 7.7 |
| Sleep Hygiene | Maternal Well-being | 13.0 Scores on a scale | Standard Deviation 7.9 |