Status:
COMPLETED
Neonatal Sleep Intervention to Improve Postpartum Hypertension
Lead Sponsor:
Alisse Hauspurg
Collaborating Sponsors:
Happiest Baby, Inc.
Conditions:
Pre-Eclampsia
Gestational Hypertension
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- ≥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
- \<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
Key Trial Info
Start Date :
July 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04864249
Start Date
July 9 2021
End Date
September 30 2022
Last Update
June 8 2023
Active Locations (1)
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1
University of Pittsburgh Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213