Clinical trial NCT04864249: Neonatal Sleep Intervention to Improve Postpartum Hypertension
Official title: The Impact of a Neonatal Sleep Intervention on Postpartum Blood Pressure in Women With Hypertensive Disorders of Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Eclampsia
Gestational Hypertension
Sleep
Keywords: Pre-Eclampsia
Gestational Hypertension
Postpartum Sleep
SNOO
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Happiest Baby, Inc.
First posted: 2021-04-28
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean Arterial Pressure
timeFrame: 6 weeks postpartum
Secondary outcomes:
measure: Mean Arterial Pressure
timeFrame: 1 week postpartum
measure: Systolic Blood Pressure
timeFrame: 1 week postpartum
measure: Diastolic Blood Pressure
timeFrame: 1 week postpartum
measure: Number of Participants on Antihypertensive Medication(s)
timeFrame: 1 week postpartum
measure: Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s)
timeFrame: 1 week postpartum
measure: Maternal Weight in Kilograms
timeFrame: 1 week postpartum
measure: Body Mass Index in kg/m^2
timeFrame: 1 week postpartum
measure: Systolic Blood Pressure
timeFrame: 6 weeks postpartum
measure: Diastolic Blood Pressure
timeFrame: 6 weeks postpartum
measure: Number of Participants on Antihypertensive Medication(s)
timeFrame: 6 weeks postpartum
measure: Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s)
timeFrame: 6 weeks postpartum
measure: Maternal Weight in Kilograms
timeFrame: 6 weeks postpartum
measure: Body Mass Index
timeFrame: 6 weeks postpartum
measure: Mean Arterial Pressure
timeFrame: 4 months postpartum
measure: Systolic Blood Pressure
timeFrame: 4 months postpartum
measure: Diastolic Blood Pressure
timeFrame: 4 months postpartum
measure: Number of Participants on Antihypertensive Medication(s)
timeFrame: 4 months postpartum
measure: Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s)
timeFrame: 4 months postpartum
measure: Maternal Weight in Kilograms
timeFrame: 4 months postpartum
measure: Body Mass Index in kg/m^2
timeFrame: 4 months postpartum
measure: Pittsburgh Sleep Quality Index Score
timeFrame: 6 weeks postpartum
measure: PROMIS Sleep Disturbance Questionnaire
timeFrame: 6 weeks postpartum
measure: Epworth Sleepiness Scale Score
timeFrame: 6 weeks postpartum
measure: Edinburgh Postnatal Depression Scale Score
timeFrame: 6 weeks postpartum
measure: Generalized Anxiety Disorder 2-item Score
timeFrame: 6 weeks postpartum
measure: Perceived Stress Scale 4 Score
timeFrame: 6 weeks postpartum
measure: Breslau 7-Item Screen for Post-traumatic Stress Disorder Score
timeFrame: 6 weeks postpartum
measure: Median Infant Total Daily Sleep
timeFrame: 6 weeks postpartum
measure: Median Infant Daily Longest Sleep Duration
timeFrame: 6 weeks postpartum
measure: Median Maternal Total Daily Sleep
timeFrame: 6 weeks postpartum
measure: Median Maternal Daily Longest Sleep Duration
timeFrame: 6 weeks postpartum
measure: Median Infant Total Daily Sleep
timeFrame: 4 months postpartum
measure: Median Infant Daily Longest Sleep Duration
timeFrame: 4 months postpartum
measure: Median Maternal Total Daily Sleep
timeFrame: 4 months postpartum
measure: Median Maternal Daily Longest Sleep Duration
timeFrame: 4 months postpartum
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Magee-Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh, Magee-Womens Hospital
name: Alisse Hauspurg, MD
role: PRINCIPAL_INVESTIGATOR
References: