Neonatal Sleep Intervention to Improve Postpartum Hypertension

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04864249
• Other study ID #: STUDY20070054
• Status: Completed
• Phase: N/A
• Start date: July 9, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 30, 2022
• Est. primary completion date: May 11, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Gestational Hypertension
• Hypertension
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia
• Sleep

Intervention

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

Locations

Country	Name	City	State
United States	University of Pittsburgh Magee-Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Alisse Hauspurg	Happiest Baby, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 weeks postpartum
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	1 week postpartum
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	1 week postpartum
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	1 week postpartum
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.	1 week postpartum
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.	1 week postpartum
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	1 week postpartum
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	1 week postpartum
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	6 weeks postpartum
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	6 weeks postpartum
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.	6 weeks postpartum
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.	6 weeks postpartum
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	6 weeks postpartum
Secondary	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
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	4 months postpartum
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	4 months postpartum
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	4 months postpartum
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.	4 months postpartum
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.	4 months postpartum
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	4 months postpartum
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	4 months postpartum
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).	6 weeks postpartum
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).	6 weeks postpartum
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.	6 weeks postpartum
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.	6 weeks postpartum
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.	6 weeks postpartum
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.	6 weeks postpartum
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.	6 weeks postpartum
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.	6 weeks postpartum
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.	6 weeks postpartum
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.	6 weeks postpartum
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.	6 weeks postpartum
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.	4 months postpartum
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.	4 months postpartum
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.	4 months postpartum
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.	4 months postpartum