N/A N=110 Randomized Treatment

Neonatal Sleep Intervention to Improve Postpartum Hypertension

Pre-Eclampsia · Gestational Hypertension · Sleep

Bottom Line

View on ClinicalTrials.gov: NCT04864249 ↗

Enrolled (actual)

110

Serious AEs

0.0%

Results posted

Jun 2023

Primary outcome: Primary: Mean Arterial Pressure — 93; 94 mm Hg — p=0.54

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SNOO (Device); Safe sleep education in the postpartum period (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Alisse Hauspurg
Primary completion: May 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Arterial Pressure	93; 94	0.56
SECONDARY Mean Arterial Pressure	93; 94	0.56
SECONDARY Systolic Blood Pressure	121; 122	0.80
SECONDARY Diastolic Blood Pressure	78; 80	0.48
SECONDARY Number of Participants on Antihypertensive Medication(s)	3; 3	0.62
SECONDARY Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s)	21; 19	0.21
SECONDARY Maternal Weight in Kilograms	77.2; 85.8	0.19
SECONDARY Body Mass Index in kg/m^2	27.8; 31.6	0.19
SECONDARY Systolic Blood Pressure	121; 122	0.80
SECONDARY Diastolic Blood Pressure	78; 80	0.48
SECONDARY Number of Participants on Antihypertensive Medication(s)	3; 3	0.62
SECONDARY Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s)	21; 19	0.21
SECONDARY Maternal Weight in Kilograms	77.2; 85.8	0.19
SECONDARY Body Mass Index	28.5; 32.1	0.22
SECONDARY Mean Arterial Pressure	93; 94	0.56
SECONDARY Systolic Blood Pressure	121; 122	0.80
SECONDARY Diastolic Blood Pressure	78; 80	0.48
SECONDARY Number of Participants on Antihypertensive Medication(s)	3; 3	0.62
SECONDARY Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s)	21; 19	0.21
SECONDARY Maternal Weight in Kilograms	77.2; 85.8	0.19
SECONDARY Body Mass Index in kg/m^2	27.8; 31.6	0.19
SECONDARY Pittsburgh Sleep Quality Index Score	8.5; 8.9	0.51
SECONDARY PROMIS Sleep Disturbance Questionnaire	55; 58	0.38
SECONDARY Epworth Sleepiness Scale Score	8.3; 7.9	0.68
SECONDARY Edinburgh Postnatal Depression Scale Score	5; 3	0.42
SECONDARY Generalized Anxiety Disorder 2-item Score	1; 1	0.94
SECONDARY Perceived Stress Scale 4 Score	3.5; 3.5	0.68
SECONDARY Breslau 7-Item Screen for Post-traumatic Stress Disorder Score	0; 0	0.31
SECONDARY Median Infant Total Daily Sleep	13.2; 13.5	0.41
SECONDARY Median Infant Daily Longest Sleep Duration	7.7; 6.5	0.09
SECONDARY Median Maternal Total Daily Sleep	7.3; 7.8	0.12
SECONDARY Median Maternal Daily Longest Sleep Duration	5.9; 5.1	0.48
SECONDARY Median Infant Total Daily Sleep	13.2; 13.5	0.41
SECONDARY Median Infant Daily Longest Sleep Duration	7.7; 6.5	0.09
SECONDARY Median Maternal Total Daily Sleep	7.3; 7.8	0.12
SECONDARY Median Maternal Daily Longest Sleep Duration	5.9; 5.1	0.48

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04864249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.