Status:
TERMINATED
UniSA BackOff! Study: Adelaide PrenaBelt Trial
Lead Sponsor:
Shiphrah Biomedical Inc.
Collaborating Sponsors:
University of South Australia
Conditions:
Stillbirth
Infant, Low Birth Weight
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Stillbirth (SB) is a devastating complication of pregnancy and contributes to over 2 million deaths globally every year. Over 20 million infants are born every year with low birth weight (LBW), which ...
Detailed Description
The ability of the PB2 prototypes to reduce the amount of time pregnant women spend sleeping on their backs at night in the home setting in the third trimester of pregnancy will be evaluated via a con...
Eligibility Criteria
Inclusion
- ≥18 years old
- low-risk singleton pregnancy
- in the last trimester of pregnancy (at least 28 weeks + 0 days but not more than 36 weeks + 0 days of gestation)
- access to and ability to use iPhone (for downloading and using Ajuvia app)
- residing in the Greater Adelaide Area.
Exclusion
- musculoskeletal disorder that prevents sleeping supine or on a certain side (e.g., arthritic shoulder)
- non-English speaking and reading
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04437407
Start Date
February 1 2020
End Date
June 15 2021
Last Update
September 2 2021
Active Locations (1)
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1
UniSA Clinical & Health Sciences
Adelaide, South Australia, Australia, 5000