Neonatal Sleep Intervention to Improve Postpartum Hypertension
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Device: 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.
Other: Safe sleep education in the postpartum period
Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
| Active Comparator: Usual Care Will receive the current standard of care of safe sleep education in the postpartum period |
Other: Safe sleep education in the postpartum period
Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
|
Outcome Measures
Primary Outcome Measures
- Mean arterial pressure [6 weeks postpartum]
Mean arterial pressure will be calculated from the systolic and diastolic blood pressures assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
Secondary Outcome Measures
- Mean arterial pressure [4 months postpartum]
Mean arterial pressure will be calculated from the systolic and diastolic blood pressures assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
- Systolic and diastolic blood pressure [6 weeks postpartum]
Systolic and diastolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
- Systolic and diastolic blood pressure [4 months postpartum]
Systolic and diastolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
- Systolic and diastolic blood pressure trend [Up to 6 months postpartum]
Participants in the study will undergo regular assessments of their systolic and diastolic blood pressure through the institution's remote monitoring program. The participant's systolic and blood pressure over the study time period will be assessed.
- 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).
- Pittsburgh Sleep Quality Index score [4 months 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).
- 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).
- PROMIS Sleep Disturbance Questionnaire [4 months 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).
- 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.
- Epworth Sleepiness Scale score [4 months 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.
- Average 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 average total daily sleep in hours will be calculated over the 7 days of sleep log data recorded.
- Average total daily sleep [4 months 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 average total daily sleep in hours will be calculated over the 7 days of sleep log data recorded.
- Average 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 average daily longest sleep duration will be calculated over the 7 days of sleep log data recorded.
- Average daily longest sleep duration [4 months 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 average daily longest sleep duration will be calculated over the 7 days of sleep log data recorded.
- 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.
- Edinburgh Postnatal Depression Scale score [4 months 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.
- Generalized Anxiety Disorder 2-item score [4 months 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.
- 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.
- Perceived Stress Scale 4 score [4 months 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.
- 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.
- Breslau 7-Item Screen for Post-traumatic Stress Disorder score [4 months 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.
- Maternal weight in kilograms [6 weeks postpartum]
Maternal weight in kilograms will be assessed using a study-provided scale at the time of the study follow-up visit
- Maternal weight in kilograms [4 months postpartum]
Maternal weight in kilograms will be assessed using a study-provided scale at the time of the study follow-up visit
Eligibility Criteria
Criteria
Inclusion Criteria:
-
≥18 years old
-
Have a singleton, full-term (37 or greater weeks of gestation), live birth of a non-anomalous fetus
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Diagnosis of gestational hypertension or pre-eclampsia by American College of Obstetricians and Gynecologists criteria
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Enrolled in the institution's postpartum blood pressure remote monitoring program
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Willing to undergo randomization
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Willing to use the SNOO for their neonate in the postpartum period if randomized to that study arm
Exclusion Criteria:
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<18 years old
-
Non-English speaking
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Diagnosis of chronic hypertension
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Diagnosis of pre-gestational diabetes
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Diagnosis of cardiac disease
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Diagnosis of kidney disease
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Diagnosis of liver disease
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Infant admitted to the neonatal intensive care unit
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Intend to use the SNOO prior to study enrollment
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Not willing to be randomized
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Not willing to use the SNOO if randomized to that study arm
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pittsburgh Magee-Womens Hospital | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- Alisse Hauspurg
- Happiest Baby, Inc.
Investigators
- Principal Investigator: Alisse Hauspurg, MD, University of Pittsburgh, Magee-Womens Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY20070054