Neonatal Sleep Intervention to Improve Postpartum Hypertension

Alisse Hauspurg

Status: Completed

Conditions: Pre-Eclampsia; Gestational Hypertension; Sleep

Treatments: Device: SNOO; Other: Safe sleep education in the postpartum period

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04864249

STUDY20070054

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

110 participants in 2 patient groups

SNOO Responsive Bassinet

Experimental group

Description:

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

Treatment:

Device: SNOO

Other: Safe sleep education in the postpartum period

Usual Care

Active Comparator group

Description:

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

Treatment:

Other: Safe sleep education in the postpartum period