Neonatal Sleep Intervention to Improve Postpartum Hypertension

Not Applicable

Completed

Conditions: Sleep
Gestational Hypertension
Pre-Eclampsia

Interventions: Other: Safe sleep education in the postpartum period
Device: SNOO

Registration Number: NCT04864249

Lead Sponsor: Alisse Hauspurg

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 110

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Safe sleep education in the postpartum period	Will receive the current standard of care of safe sleep education in the postpartum period
SNOO Responsive Bassinet	SNOO	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
SNOO Responsive Bassinet	Safe sleep education in the postpartum period	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

Primary Outcome Measures

Name	Time	Method
Mean Arterial Pressure	6 weeks postpartum	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s)	4 months postpartum	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.
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.
Systolic Blood Pressure	4 months postpartum	Systolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
Number of Participants on Antihypertensive Medication(s)	4 months postpartum	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.
Body Mass Index in kg/m^2	4 months postpartum	Body mass index in kg/m\^2 will be assessed at the time of the study follow-up visit
Body Mass Index	6 weeks postpartum	Body mass index in kg/m\^2 will be assessed 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
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.
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.
Mean Arterial Pressure	4 months postpartum	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
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).
Median Maternal 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 median total daily sleep in hours per day will be calculated over the 7 days of sleep log data recorded.
Median Maternal 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 median daily longest sleep duration in hours per day will be calculated over the 7 days of sleep log data recorded.
Diastolic Blood Pressure	4 months postpartum	Diastolic blood pressure will be assessed using a study-provided blood pressure cuff at the time of the study follow-up visit
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).
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.
Median Infant Total Daily Sleep	4 months postpartum	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.
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.
Median Infant Daily Longest Sleep Duration	4 months postpartum	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.