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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
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.
Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
University of Pittsburgh Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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