Neonatal Sleep Intervention to Improve Postpartum Hypertension

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-09

Study Completion Date

2022-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pre-Eclampsia Gestational Hypertension Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

SNOO

Intervention Type DEVICE

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.

Safe sleep education in the postpartum period

Intervention Type OTHER

Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home

Usual Care

Will receive the current standard of care of safe sleep education in the postpartum period

Group Type ACTIVE_COMPARATOR

Safe sleep education in the postpartum period

Intervention Type OTHER

Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home

Interventions

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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.

Intervention Type DEVICE

Safe sleep education in the postpartum period

Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No