Gestational Hypertension, Pre-Eclampsia, Sleep
Conditions
Keywords
Pre-Eclampsia, Gestational Hypertension, Postpartum Sleep, SNOO
Brief summary
The investigators are conducting a single center, randomized controlled trial testing the impact of a neonatal sleep intervention, the SNOO, on reducing maternal blood pressure (BP) in the postpartum period in women with hypertensive disorders of pregnancy. The SNOO is a responsive bassinet designed to automatically calm and consolidate infants by responding to their cries. Use of the SNOO has been demonstrated to improve infant sleep by 1-2 hours nightly, thus increasing maternal sleep time. The investigators plan for 110 women with pregnancies complicated by gestational hypertension or pre-eclampsia to be randomized 1:1 to either receive and use the SNOO responsive bassinet for their infants, or to receive the usual care of safe sleep education. Women will be followed longitudinally through 6 months postpartum with serial BPs, weights, mood assessments, and subjective and objective sleep assessments. The investigators hypothesize that for women with pregnancies complicated by gestational hypertension or preeclampsia, that poor maternal sleep quality contributes to increased BP in the postpartum period. The investigators further propose that compared to usual care (safe sleep education), an intervention targeted to improve neonatal sleep (the SNOO), and thus maternal sleep, will improve postpartum BP for these women.
Interventions
DEVICESNOO
The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
OTHERSafe sleep education in the postpartum period
Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
Sponsors
Happiest Baby, Inc.
Alisse Hauspurg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years old * Have a singleton, full-term (37 or greater weeks of gestation), live birth of a non-anomalous fetus * Diagnosis of gestational hypertension or pre-eclampsia by American College of Obstetricians and Gynecologists criteria * Enrolled in the institution's postpartum blood pressure remote monitoring program * Willing to undergo randomization * Willing to use the SNOO for their neonate in the postpartum period if randomized to that study arm
Exclusion criteria
* \<18 years old * Non-English speaking * Diagnosis of chronic hypertension * Diagnosis of pre-gestational diabetes * Diagnosis of cardiac disease * Diagnosis of kidney disease * Diagnosis of liver disease * Infant admitted to the neonatal intensive care unit * Intend to use the SNOO prior to study enrollment * Not willing to be randomized * Not willing to use the SNOO if randomized to that study arm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Arterial Pressure | 6 weeks postpartum | Mean arterial pressure will be calculated from the systolic and diastolic blood pressures \[(2 \* diastolic blood pressure + systolic blood pressure) / 3\] assessed using a study-provided blood pressure cuff at the time of the study follow-up visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | 1 week postpartum | Systolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit |
| Diastolic Blood Pressure | 1 week postpartum | Diastolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit |
| Number of Participants on Antihypertensive Medication(s) | 1 week postpartum | Whether or not the participant is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit. |
| Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s) | 1 week postpartum | Whether or not the participant meets criteria for Stage 1 or greater hypertension or is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit. The American College of Cardiology categorizes blood pressure into normal, elevated, Stage 1, Stage 2, or hypertensive crisis, with hypertensive crisis being the most severe. Stage 1 hypertension was defined as a systolic blood pressure of ≥130 and/or or diastolic blood pressure of ≥80. |
| Maternal Weight in Kilograms | 1 week postpartum | Maternal weight in kilograms will be assessed using a study-provided scale at the time of the study follow-up visit |
| Body Mass Index in kg/m^2 | 1 week postpartum | Body mass index in kg/m\^2 will be assessed at the time of the study follow-up visit |
| Perceived Stress Scale 4 Score | 6 weeks postpartum | The Perceived Stress Scale 4 contains 4 self-rated questions regarding stress levels. Scores range from 0 to 16. Higher scores a correlated to more stress. |
| Body Mass Index | 6 weeks postpartum | Body mass index in kg/m\^2 will be assessed at the time of the study follow-up visit |
| Pittsburgh Sleep Quality Index Score | 6 weeks postpartum | The Pittsburgh Sleep Quality Index contains 19 self-rated questions and 5 questions rated by the bed partner or roommate if one is available; only the self-rated questions are included in the scoring. Scores range from 0 (indicating no difficulties in any aspect of sleep) to 21 (indicating severe difficulties in all areas). |
| Mean Arterial Pressure | 1 week postpartum | Mean arterial pressure will be calculated from the systolic and diastolic blood pressures \[(2 \* diastolic blood pressure + systolic blood pressure) / 3\] assessed using a study-provided blood pressure cuff at the time of the study follow-up visit |
| Epworth Sleepiness Scale Score | 6 weeks postpartum | The Epworth Sleepiness Scale contains 8 self-rated questions to determine the level of daytime sleepiness in individuals. Scores range from 0 to 24. A score of 10 or more is concerning for excessive daytime sleepiness. |
| Edinburgh Postnatal Depression Scale Score | 6 weeks postpartum | The Edinburgh Postnatal Depression Scale contains 10 self-rated questions to assess for major depression in the postnatal period. Scores range from 0 to 30. A score of 13 or greater is concerning for major depression. |
| Generalized Anxiety Disorder 2-item Score | 6 weeks postpartum | The Generalized Anxiety Disorder 2-item contains 2 self-rated questions to screen for generalized anxiety disorder. Scores range from 0 to 6. A score of 3 or greater is concerning for generalized anxiety disorder. |
| Breslau 7-Item Screen for Post-traumatic Stress Disorder Score | 6 weeks postpartum | The Breslau 7-Item Screen for Posttraumatic Stress Disorder contains 7 self-rated questions assessing symptoms of post-traumatic stress disorder. Scores range from 0 to 7. Scores of 4 or above are concerning for post-traumatic stress disorder. |
| Median Infant Total Daily Sleep | 6 weeks postpartum | Participants will be asked to self-complete 7 days of an infant sleep log in the 7 days prior to the study follow-up visit. The median total daily sleep in hours per day will be calculated over the 7 days of sleep log data recorded. |
| Median Infant Daily Longest Sleep Duration | 6 weeks postpartum | Participants will be asked to self-complete 7 days of an infant sleep log in the 7 days prior to the study follow-up visit. The median daily longest sleep duration in hours per day will be calculated over the 7 days of sleep log data recorded. |
| Median Maternal Total Daily Sleep | 6 weeks postpartum | Participants will be asked to self-complete 7 days of a maternal sleep log in the 7 days prior to the study follow-up visit. The median total daily sleep in hours per day will be calculated over the 7 days of sleep log data recorded. |
| Median Maternal Daily Longest Sleep Duration | 6 weeks postpartum | Participants will be asked to self-complete 7 days of a maternal sleep log in the 7 days prior to the study follow-up visit. The median daily longest sleep duration in hours per day will be calculated over the 7 days of sleep log data recorded. |
| PROMIS Sleep Disturbance Questionnaire | 6 weeks postpartum | The PROMIS Sleep Disturbance Questionnaire contains 27 self-rated questions on subjective sleep quality. Scores range from 27 (indicating excellent sleep quality) to 135 (indicating poor sleep quality). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SNOO Responsive Bassinet Will receive and be instructed on the use of the SNOO responsive bassinet for their newborn + the current standard of care of safe sleep education in the postpartum period
SNOO: The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home | 54 |
| Usual Care Will receive the current standard of care of safe sleep education in the postpartum period
Safe sleep education in the postpartum period: Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home | 56 |
| Total | 110 |
Baseline characteristics
| Characteristic | SNOO Responsive Bassinet | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 31.7 years STANDARD_DEVIATION 5.5 | 30.5 years STANDARD_DEVIATION 4.8 | 31.1 years STANDARD_DEVIATION 5.2 |
| Annual household income <$75,000 | 21 Participants | 26 Participants | 47 Participants |
| Annual household income $75,000+ | 31 Participants | 24 Participants | 55 Participants |
| Annual household income Prefer not to answer | 2 Participants | 6 Participants | 8 Participants |
| Blood loss during delivery | 300 mL | 300 mL | 300 mL |
| Body Mass Index at postpartum enrollment in kg/m^2 | 32.2 kg/m^2 | 34.5 kg/m^2 | 33.2 kg/m^2 |
| Body Mass Index in kg/m^2 at first prenatal visit | 27.7 kg/m^2 | 30.0 kg/m^2 | 29.1 kg/m^2 |
| Body Mass Index on Labor and Delivery admission in kg/m^2 | 33.8 kg/m^2 | 35.5 kg/m^2 | 34.9 kg/m^2 |
| Diastolic blood pressure at first prenatal visit | 73 mm Hg STANDARD_DEVIATION 8 | 76 mm Hg STANDARD_DEVIATION 9 | 74 mm Hg STANDARD_DEVIATION 9 |
| Diastolic blood pressure at postpartum enrollment | 85 mm Hg STANDARD_DEVIATION 8 | 86 mm Hg STANDARD_DEVIATION 10 | 86 mm Hg STANDARD_DEVIATION 9 |
| Diastolic blood pressure on Labor and Delivery admission | 86 mm Hg STANDARD_DEVIATION 13 | 86 mm Hg STANDARD_DEVIATION 10 | 86 mm Hg STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 54 Participants | 107 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ever breastfeed | 48 Participants | 49 Participants | 97 Participants |
| Gestational age at delivery | 38.1 weeks | 38.1 weeks | 38.1 weeks |
| Gestational age at diagnosis of hypertensive disorder | 38.0 weeks | 37.9 weeks | 37.9 weeks |
| Insurance status during pregnancy No insurance | 2 Participants | 2 Participants | 4 Participants |
| Insurance status during pregnancy Other | 1 Participants | 1 Participants | 2 Participants |
| Insurance status during pregnancy Private | 42 Participants | 36 Participants | 78 Participants |
| Insurance status during pregnancy Public | 9 Participants | 17 Participants | 26 Participants |
| Mean arterial pressure at first prenatal visit | 87 mm Hg STANDARD_DEVIATION 7 | 90 mm Hg STANDARD_DEVIATION 8 | 89 mm Hg STANDARD_DEVIATION 8 |
| Mean arterial pressure at postpartum enrollment | 102 mm Hg STANDARD_DEVIATION 8 | 102 mm Hg STANDARD_DEVIATION 11 | 102 mm Hg STANDARD_DEVIATION 10 |
| Mean arterial pressure on Labor and Delivery admission | 103 mm Hg STANDARD_DEVIATION 12 | 102 mm Hg STANDARD_DEVIATION 9 | 103 mm Hg STANDARD_DEVIATION 11 |
| Mode of delivery Cesarean delivery | 18 Participants | 21 Participants | 39 Participants |
| Mode of delivery Forceps-assisted vaginal delivery | 1 Participants | 1 Participants | 2 Participants |
| Mode of delivery Vacuum-assisted vaginal delivery | 0 Participants | 3 Participants | 3 Participants |
| Mode of delivery Vaginal delivery | 35 Participants | 31 Participants | 66 Participants |
| Neonatal birthweight | 3155 g | 3055 g | 3125 g |
| Number of participants on antihypertensive medication(s) at postpartum enrollment | 4 Participants | 3 Participants | 7 Participants |
| Number of participants with Stage 1+ hypertension or on antihypertensive medication(s) | 9 Participants | 11 Participants | 20 Participants |
| Other children also living at home | 25 Participants | 23 Participants | 48 Participants |
| Partner status Married or partnered | 49 Participants | 43 Participants | 92 Participants |
| Partner status Separated or divorced | 0 Participants | 2 Participants | 2 Participants |
| Partner status Single | 5 Participants | 11 Participants | 16 Participants |
| Pre-delivery diagnosis of depression | 17 Participants | 18 Participants | 35 Participants |
| Race/Ethnicity, Customized Self-reported race Asian or Pacific Islander | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Self-reported race Black | 10 Participants | 10 Participants | 20 Participants |
| Race/Ethnicity, Customized Self-reported race Other | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Self-reported race White | 43 Participants | 41 Participants | 84 Participants |
| Sex: Female, Male Female | 54 Participants | 56 Participants | 110 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Smoking within the past 2 years | 6 Participants | 8 Participants | 14 Participants |
| Systolic blood pressure at first prenatal visit | 115 mm Hg STANDARD_DEVIATION 10 | 119 mm Hg STANDARD_DEVIATION 9 | 118 mm Hg STANDARD_DEVIATION 10 |
| Systolic blood pressure at postpartum enrollment | 135 mm Hg STANDARD_DEVIATION 12 | 134 mm Hg STANDARD_DEVIATION 14 | 135 mm Hg STANDARD_DEVIATION 13 |
| Systolic blood pressure on Labor and Delivery admission | 140 mm Hg STANDARD_DEVIATION 13 | 135 mm Hg STANDARD_DEVIATION 12 | 138 mm Hg STANDARD_DEVIATION 13 |
| Type of hypertensive disorder Gestational hypertension | 24 Participants | 33 Participants | 57 Participants |
| Type of hypertensive disorder Preeclampsia without severe features | 15 Participants | 11 Participants | 26 Participants |
| Type of hypertensive disorder Preeclampsia with severe features | 15 Participants | 12 Participants | 27 Participants |
| Weight at postpartum enrollment in kg | 87.2 kg | 92.7 kg | 88.6 kg |
| Weight in kg at first prenatal visit | 74.8 kg | 81.0 kg | 76.3 kg |
| Weight on Labor and Delivery admission in kg | 90.9 kg | 93.5 kg | 91.6 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 56 |
| other Total, other adverse events | 0 / 54 | 0 / 56 |
| serious Total, serious adverse events | 0 / 54 | 0 / 56 |
Outcome results
Primary
Mean Arterial Pressure
Mean arterial pressure will be calculated from the systolic and diastolic blood pressures \[(2 \* diastolic blood pressure + systolic blood pressure) / 3\] assessed using a study-provided blood pressure cuff at the time of the study follow-up visit.
Time frame: 6 weeks postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SNOO Responsive Bassinet | Mean Arterial Pressure | 93 mm Hg | Standard Deviation 8 |
| Usual Care | Mean Arterial Pressure | 94 mm Hg | Standard Deviation 8 |
p-value: 0.54t-test, 2 sided
Secondary
Body Mass Index
Body mass index in kg/m\^2 will be assessed at the time of the study follow-up visit
Time frame: 6 weeks postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNOO Responsive Bassinet | Body Mass Index | 28.5 kg/m^2 |
| Usual Care | Body Mass Index | 32.1 kg/m^2 |
p-value: 0.22Wilcoxon (Mann-Whitney)
Secondary
Body Mass Index in kg/m^2
Body mass index in kg/m\^2 will be assessed at the time of the study follow-up visit
Time frame: 4 months postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNOO Responsive Bassinet | Body Mass Index in kg/m^2 | 27.8 kg/m^2 |
| Usual Care | Body Mass Index in kg/m^2 | 31.6 kg/m^2 |
p-value: 0.19Wilcoxon (Mann-Whitney)
Secondary
Body Mass Index in kg/m^2
Body mass index in kg/m\^2 will be assessed at the time of the study follow-up visit
Time frame: 1 week postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNOO Responsive Bassinet | Body Mass Index in kg/m^2 | 29.4 kg/m^2 |
| Usual Care | Body Mass Index in kg/m^2 | 31.6 kg/m^2 |
p-value: 0.55Wilcoxon (Mann-Whitney)
Secondary
Breslau 7-Item Screen for Post-traumatic Stress Disorder Score
The Breslau 7-Item Screen for Posttraumatic Stress Disorder contains 7 self-rated questions assessing symptoms of post-traumatic stress disorder. Scores range from 0 to 7. Scores of 4 or above are concerning for post-traumatic stress disorder.
Time frame: 6 weeks postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNOO Responsive Bassinet | Breslau 7-Item Screen for Post-traumatic Stress Disorder Score | 0 score on a scale |
| Usual Care | Breslau 7-Item Screen for Post-traumatic Stress Disorder Score | 0 score on a scale |
p-value: 0.31Wilcoxon (Mann-Whitney)
Secondary
Diastolic Blood Pressure
Diastolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
Time frame: 6 weeks postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SNOO Responsive Bassinet | Diastolic Blood Pressure | 79 mm Hg | Standard Deviation 8 |
| Usual Care | Diastolic Blood Pressure | 80 mm Hg | Standard Deviation 8 |
p-value: 0.62t-test, 2 sided
Secondary
Diastolic Blood Pressure
Diastolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
Time frame: 1 week postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SNOO Responsive Bassinet | Diastolic Blood Pressure | 83 mm Hg | Standard Deviation 11 |
| Usual Care | Diastolic Blood Pressure | 89 mm Hg | Standard Deviation 8 |
p-value: 0.003t-test, 2 sided
Secondary
Diastolic Blood Pressure
Diastolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
Time frame: 4 months postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SNOO Responsive Bassinet | Diastolic Blood Pressure | 78 mm Hg | Standard Deviation 10 |
| Usual Care | Diastolic Blood Pressure | 80 mm Hg | Standard Deviation 7 |
p-value: 0.48t-test, 2 sided
Secondary
Edinburgh Postnatal Depression Scale Score
The Edinburgh Postnatal Depression Scale contains 10 self-rated questions to assess for major depression in the postnatal period. Scores range from 0 to 30. A score of 13 or greater is concerning for major depression.
Time frame: 6 weeks postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNOO Responsive Bassinet | Edinburgh Postnatal Depression Scale Score | 5 score on a scale |
| Usual Care | Edinburgh Postnatal Depression Scale Score | 3 score on a scale |
p-value: 0.42Wilcoxon (Mann-Whitney)
Secondary
Epworth Sleepiness Scale Score
The Epworth Sleepiness Scale contains 8 self-rated questions to determine the level of daytime sleepiness in individuals. Scores range from 0 to 24. A score of 10 or more is concerning for excessive daytime sleepiness.
Time frame: 6 weeks postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SNOO Responsive Bassinet | Epworth Sleepiness Scale Score | 8.3 score on a scale | Standard Deviation 4.1 |
| Usual Care | Epworth Sleepiness Scale Score | 7.9 score on a scale | Standard Deviation 3.7 |
p-value: 0.68t-test, 2 sided
Secondary
Generalized Anxiety Disorder 2-item Score
The Generalized Anxiety Disorder 2-item contains 2 self-rated questions to screen for generalized anxiety disorder. Scores range from 0 to 6. A score of 3 or greater is concerning for generalized anxiety disorder.
Time frame: 6 weeks postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNOO Responsive Bassinet | Generalized Anxiety Disorder 2-item Score | 1 score on a scale |
| Usual Care | Generalized Anxiety Disorder 2-item Score | 1 score on a scale |
p-value: 0.94Wilcoxon (Mann-Whitney)
Secondary
Maternal Weight in Kilograms
Maternal weight in kilograms will be assessed using a study-provided scale at the time of the study follow-up visit
Time frame: 4 months postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNOO Responsive Bassinet | Maternal Weight in Kilograms | 77.2 kg |
| Usual Care | Maternal Weight in Kilograms | 85.8 kg |
p-value: 0.19Wilcoxon (Mann-Whitney)
Secondary
Maternal Weight in Kilograms
Maternal weight in kilograms will be assessed using a study-provided scale at the time of the study follow-up visit
Time frame: 1 week postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNOO Responsive Bassinet | Maternal Weight in Kilograms | 81.2 kg |
| Usual Care | Maternal Weight in Kilograms | 88.0 kg |
p-value: 0.51Wilcoxon (Mann-Whitney)
Secondary
Maternal Weight in Kilograms
Maternal weight in kilograms will be assessed using a study-provided scale at the time of the study follow-up visit
Time frame: 6 weeks postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNOO Responsive Bassinet | Maternal Weight in Kilograms | 76.7 kg |
| Usual Care | Maternal Weight in Kilograms | 87.0 kg |
p-value: 0.22Wilcoxon (Mann-Whitney)
Secondary
Mean Arterial Pressure
Mean arterial pressure will be calculated from the systolic and diastolic blood pressures \[(2 \* diastolic blood pressure + systolic blood pressure) / 3\] assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
Time frame: 4 months postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SNOO Responsive Bassinet | Mean Arterial Pressure | 93 mm Hg | Standard Deviation 9 |
| Usual Care | Mean Arterial Pressure | 94 mm Hg | Standard Deviation 8 |
p-value: 0.56t-test, 2 sided
Secondary
Mean Arterial Pressure
Mean arterial pressure will be calculated from the systolic and diastolic blood pressures \[(2 \* diastolic blood pressure + systolic blood pressure) / 3\] assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
Time frame: 1 week postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SNOO Responsive Bassinet | Mean Arterial Pressure | 99 mm Hg | Standard Deviation 10 |
| Usual Care | Mean Arterial Pressure | 103 mm Hg | Standard Deviation 7 |
p-value: 0.04t-test, 2 sided
Secondary
Median Infant Daily Longest Sleep Duration
Participants will be asked to self-complete 7 days of an infant sleep log in the 7 days prior to the study follow-up visit. The median daily longest sleep duration in hours per day will be calculated over the 7 days of sleep log data recorded.
Time frame: 6 weeks postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNOO Responsive Bassinet | Median Infant Daily Longest Sleep Duration | 4.0 hours per day |
| Usual Care | Median Infant Daily Longest Sleep Duration | 4.0 hours per day |
p-value: 0.43Wilcoxon (Mann-Whitney)
Secondary
Median Infant Daily Longest Sleep Duration
Participants will be asked to self-complete 7 days of an infant sleep log in the 7 days prior to the study follow-up visit. The median daily longest sleep duration in hours per day will be calculated over the 7 days of sleep log data recorded.
Time frame: 4 months postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNOO Responsive Bassinet | Median Infant Daily Longest Sleep Duration | 7.7 hours per day |
| Usual Care | Median Infant Daily Longest Sleep Duration | 6.5 hours per day |
p-value: 0.09Wilcoxon (Mann-Whitney)
Secondary
Median Infant Total Daily Sleep
Participants will be asked to self-complete 7 days of an infant sleep log in the 7 days prior to the study follow-up visit. The median total daily sleep in hours per day will be calculated over the 7 days of sleep log data recorded.
Time frame: 6 weeks postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNOO Responsive Bassinet | Median Infant Total Daily Sleep | 13.6 hours per day |
| Usual Care | Median Infant Total Daily Sleep | 13.7 hours per day |
p-value: 0.52Wilcoxon (Mann-Whitney)
Secondary
Median Infant Total Daily Sleep
Participants will be asked to self-complete 7 days of an infant sleep log in the 7 days prior to the study follow-up visit. The median total daily sleep in hours per day will be calculated over the 7 days of sleep log data recorded.
Time frame: 4 months postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNOO Responsive Bassinet | Median Infant Total Daily Sleep | 13.2 hours per day |
| Usual Care | Median Infant Total Daily Sleep | 13.5 hours per day |
p-value: 0.41Wilcoxon (Mann-Whitney)
Secondary
Median Maternal Daily Longest Sleep Duration
Participants will be asked to self-complete 7 days of a maternal sleep log in the 7 days prior to the study follow-up visit. The median daily longest sleep duration in hours per day will be calculated over the 7 days of sleep log data recorded.
Time frame: 4 months postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNOO Responsive Bassinet | Median Maternal Daily Longest Sleep Duration | 5.9 hours per day |
| Usual Care | Median Maternal Daily Longest Sleep Duration | 5.1 hours per day |
p-value: 0.48Wilcoxon (Mann-Whitney)
Secondary
Median Maternal Daily Longest Sleep Duration
Participants will be asked to self-complete 7 days of a maternal sleep log in the 7 days prior to the study follow-up visit. The median daily longest sleep duration in hours per day will be calculated over the 7 days of sleep log data recorded.
Time frame: 6 weeks postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNOO Responsive Bassinet | Median Maternal Daily Longest Sleep Duration | 3.4 hours per day |
| Usual Care | Median Maternal Daily Longest Sleep Duration | 3.6 hours per day |
p-value: 0.47Wilcoxon (Mann-Whitney)
Secondary
Median Maternal Total Daily Sleep
Participants will be asked to self-complete 7 days of a maternal sleep log in the 7 days prior to the study follow-up visit. The median total daily sleep in hours per day will be calculated over the 7 days of sleep log data recorded.
Time frame: 4 months postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNOO Responsive Bassinet | Median Maternal Total Daily Sleep | 7.3 hours per day |
| Usual Care | Median Maternal Total Daily Sleep | 7.8 hours per day |
p-value: 0.12Wilcoxon (Mann-Whitney)
Secondary
Median Maternal Total Daily Sleep
Participants will be asked to self-complete 7 days of a maternal sleep log in the 7 days prior to the study follow-up visit. The median total daily sleep in hours per day will be calculated over the 7 days of sleep log data recorded.
Time frame: 6 weeks postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNOO Responsive Bassinet | Median Maternal Total Daily Sleep | 6.4 hours per day |
| Usual Care | Median Maternal Total Daily Sleep | 7.4 hours per day |
p-value: 0.07Wilcoxon (Mann-Whitney)
Secondary
Number of Participants on Antihypertensive Medication(s)
Whether or not the participant is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit.
Time frame: 4 months postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SNOO Responsive Bassinet | Number of Participants on Antihypertensive Medication(s) | 3 Participants |
| Usual Care | Number of Participants on Antihypertensive Medication(s) | 3 Participants |
p-value: 0.62Chi-squared
Secondary
Number of Participants on Antihypertensive Medication(s)
Whether or not the participant is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit.
Time frame: 6 weeks postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SNOO Responsive Bassinet | Number of Participants on Antihypertensive Medication(s) | 8 Participants |
| Usual Care | Number of Participants on Antihypertensive Medication(s) | 13 Participants |
p-value: 0.19Chi-squared
Secondary
Number of Participants on Antihypertensive Medication(s)
Whether or not the participant is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit.
Time frame: 1 week postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SNOO Responsive Bassinet | Number of Participants on Antihypertensive Medication(s) | 12 Participants |
| Usual Care | Number of Participants on Antihypertensive Medication(s) | 19 Participants |
p-value: 0.15Chi-squared
Secondary
Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s)
Whether or not the participant meets criteria for Stage 1 or greater hypertension or is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit. The American College of Cardiology categorizes blood pressure into normal, elevated, Stage 1, Stage 2, or hypertensive crisis, with hypertensive crisis being the most severe. Stage 1 hypertension was defined as a systolic blood pressure of ≥130 and/or or diastolic blood pressure of ≥80.
Time frame: 6 weeks postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SNOO Responsive Bassinet | Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s) | 31 Participants |
| Usual Care | Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s) | 32 Participants |
p-value: 0.66Chi-squared
Secondary
Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s)
Whether or not the participant meets criteria for Stage 1 or greater hypertension or is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit. The American College of Cardiology categorizes blood pressure into normal, elevated, Stage 1, Stage 2, or hypertensive crisis, with hypertensive crisis being the most severe. Stage 1 hypertension was defined as a systolic blood pressure of ≥130 and/or or diastolic blood pressure of ≥80.
Time frame: 4 months postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SNOO Responsive Bassinet | Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s) | 21 Participants |
| Usual Care | Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s) | 19 Participants |
p-value: 0.21Chi-squared
Secondary
Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s)
Whether or not the participant meets criteria for Stage 1 or greater hypertension or is taking antihypertensive medication(s) for blood pressure control will be assessed at the time of the study follow-up visit. The American College of Cardiology categorizes blood pressure into normal, elevated, Stage 1, Stage 2, or hypertensive crisis, with hypertensive crisis being the most severe. Stage 1 hypertension was defined as a systolic blood pressure of ≥130 and/or or diastolic blood pressure of ≥80.
Time frame: 1 week postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SNOO Responsive Bassinet | Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s) | 43 Participants |
| Usual Care | Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s) | 44 Participants |
p-value: 0.84Chi-squared
Secondary
Perceived Stress Scale 4 Score
The Perceived Stress Scale 4 contains 4 self-rated questions regarding stress levels. Scores range from 0 to 16. Higher scores a correlated to more stress.
Time frame: 6 weeks postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNOO Responsive Bassinet | Perceived Stress Scale 4 Score | 3.5 score on a scale |
| Usual Care | Perceived Stress Scale 4 Score | 3.5 score on a scale |
p-value: 0.68Wilcoxon (Mann-Whitney)
Secondary
Pittsburgh Sleep Quality Index Score
The Pittsburgh Sleep Quality Index contains 19 self-rated questions and 5 questions rated by the bed partner or roommate if one is available; only the self-rated questions are included in the scoring. Scores range from 0 (indicating no difficulties in any aspect of sleep) to 21 (indicating severe difficulties in all areas).
Time frame: 6 weeks postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SNOO Responsive Bassinet | Pittsburgh Sleep Quality Index Score | 8.5 score on a scale | Standard Deviation 3 |
| Usual Care | Pittsburgh Sleep Quality Index Score | 8.9 score on a scale | Standard Deviation 3.2 |
p-value: 0.51t-test, 2 sided
Secondary
PROMIS Sleep Disturbance Questionnaire
The PROMIS Sleep Disturbance Questionnaire contains 27 self-rated questions on subjective sleep quality. Scores range from 27 (indicating excellent sleep quality) to 135 (indicating poor sleep quality).
Time frame: 6 weeks postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SNOO Responsive Bassinet | PROMIS Sleep Disturbance Questionnaire | 55 units on a scale | Standard Deviation 17 |
| Usual Care | PROMIS Sleep Disturbance Questionnaire | 58 units on a scale | Standard Deviation 19 |
p-value: 0.38t-test, 2 sided
Secondary
Systolic Blood Pressure
Systolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
Time frame: 1 week postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SNOO Responsive Bassinet | Systolic Blood Pressure | 131 mm Hg | Standard Deviation 14 |
| Usual Care | Systolic Blood Pressure | 130 mm Hg | Standard Deviation 10 |
p-value: 0.89t-test, 2 sided
Secondary
Systolic Blood Pressure
Systolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
Time frame: 6 weeks postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SNOO Responsive Bassinet | Systolic Blood Pressure | 121 mm Hg | Standard Deviation 10 |
| Usual Care | Systolic Blood Pressure | 122 mm Hg | Standard Deviation 11 |
p-value: 0.55t-test, 2 sided
Secondary
Systolic Blood Pressure
Systolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
Time frame: 4 months postpartum
Population: Some participants lost to follow-up and/or did not complete this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SNOO Responsive Bassinet | Systolic Blood Pressure | 121 mm Hg | Standard Deviation 10 |
| Usual Care | Systolic Blood Pressure | 122 mm Hg | Standard Deviation 12 |
p-value: 0.8t-test, 2 sided