Neonatal Sleep Intervention to Improve Postpartum Hypertension

NCT04864249 | Completed Results FDA Device

• 1 other identifier: STUDY20070054
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Eclampsia; Gestational Hypertension; Sleep

Keywords

Pre-Eclampsia; Gestational Hypertension; Postpartum Sleep; SNOO

Outcome Measures

Primary Outcomes (1)

• Mean Arterial Pressure

  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.

  6 weeks postpartum

Secondary Outcomes (35)

• Mean Arterial Pressure

  1 week postpartum

• Systolic Blood Pressure

  1 week postpartum

• Diastolic Blood Pressure

  1 week postpartum

• Number of Participants on Antihypertensive Medication(s)

  1 week postpartum

• Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s)

  1 week postpartum

Study Arms (2)

SNOO Responsive Bassinet

EXPERIMENTAL

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

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

Usual Care

ACTIVE COMPARATOR

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

Other: Safe sleep education in the postpartum period

Interventions

SNOO 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.

SNOO Responsive Bassinet

Safe sleep education in the postpartum period OTHER

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

SNOO Responsive Bassinet; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Alisse Hauspurg: lead
• Happiest Baby, Inc.: collaborator

Study Sites (1)

University of Pittsburgh Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Wang TL, Quinn BA, Hart R, Wiener AA, Facco FL, Simhan HN, Hauspurg AK. The effect of a neonatal sleep intervention on maternal postpartum hypertension: a randomized trial. Am J Obstet Gynecol MFM. 2024 Feb;6(2):101239. doi: 10.1016/j.ajogmf.2023.101239. Epub 2023 Dec 10.

  PMID: 38072236 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Alisse Hauspurg
• Organization: University of Pittsburgh Medical Center, Magee-Womens Hospital

janickia@upmc.edu

412-641-1381

Study Officials

• Alisse Hauspurg, MD

  University of Pittsburgh, Magee-Womens Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: April 28, 2021
• Study Start: July 9, 2021
• Primary Completion: May 11, 2022
• Study Completion: September 30, 2022
• Last Updated: June 8, 2023
• Results First Posted: June 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)