Neonatal Sleep Intervention to Improve Postpartum Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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The Impact of a Neonatal Sleep Intervention on Postpartum Blood Pressure in Women With Hypertensive Disorders of Pregnancy

Conditions
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Pre-Eclampsia, Gestational Hypertension, Sleep

Intervention / Treatment
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* Device: SNOO
* Other: Safe sleep education in the postpartum period


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SNOO Responsive Bassinet<br>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<br>* 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.<br>Other: Safe sleep education in the postpartum period<br>* Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home<br>|
| Active Comparator: Usual Care<br>Will receive the current standard of care of safe sleep education in the postpartum period | Other: Safe sleep education in the postpartum period<br>* Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 4 months 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 | 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 | 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 | 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. | 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. | 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 | 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 | 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 | 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 | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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. | 4 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-Eclampsia, Gestational Hypertension, Postpartum Sleep, SNOO