Neonatal Sleep Intervention to Improve Postpartum Hypertension

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

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 Overview

• Status: Completed
• Conditions: Sleep; Pre-Eclampsia; Gestational Hypertension
• Intervention / Treatment: Device: SNOO; Other: Safe sleep education in the postpartum period

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Magee-Womens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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
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
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
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
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

Collaborators and Investigators

• Sponsor: Alisse Hauspurg
• Collaborators: Happiest Baby, Inc.
• Investigators: Principal Investigator: Alisse Hauspurg, MD, University of Pittsburgh, Magee-Womens Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2021
• Primary Completion (Actual): May 11, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: April 24, 2021
• First Submitted That Met QC Criteria: April 24, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Pre-Eclampsia; Gestational Hypertension; Postpartum Sleep; SNOO
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Eclampsia; Pre-Eclampsia; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: STUDY20070054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes