TerminatedNot Applicable

UniSA BackOff! Study: Adelaide PrenaBelt Trial

Stopped: Participant dropout and technical difficulties

Australia6 participantsStarted 2020-02-01

Plain-language 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 is associated with a twenty times increased risk of death in the first year of life and high rates of short- and long-term illnesses. Sleeping on one's back during pregnancy has recently emerged as a potential risk factor for LBW and SB in the medical literature. In high-income countries, SB rates have mostly remained the same in the past two decades and targeting modifiable risk factors could help reduce the number of SB and LBW in the population. When a pregnant woman sleeps on her back, her body position compresses underlying blood vessels and reduces blood flow to the developing baby. This body position could cause unpleasant symptoms for the mother and result in LBW or SB of her baby. Lying on her side or with a slight lateral tilt helps relieve this compression. One way to keep people off their back while sleeping is by using positional therapy (PT). It is a simple, safe, inexpensive and effective intervention for preventing people who snore or people who's breathing pauses during sleep from sleeping on their back. Reducing the amount of time pregnant women sleep on their back could help reduce SB and LBW rates. The investigators developed a PT device (PrenaBelt) and tested it in three clinical trials, which demonstrated that it significantly decreases the number of time women spend sleeping on their back. Using feedback from our previous research, the investigators developed five additional devices that will be tested in this study. The purpose of this study is to evaluate the new PrenaBelt (PB2) prototypes' ability to reduce the amount of time pregnant women sleep on their backs in the third trimester of pregnancy, validate the Ajuvia Sleep Monitor, and collect feedback on the devices. Demonstrating that the sleeping position of pregnant women can be modified through the use of a simple, inexpensive PT intervention may be one of the keys to achieving significant reductions in LBW and late SB rates in Australia and worldwide.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ≥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 Criteria: * musculoskeletal disorder that prevents sleeping supine or on a certain side (e.g., arthritic shoulder) * non-English speaking and reading

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sensitivity of Ajuvia for supine position

Timeframe: 1 night (approximately 8 hours)

Specificity of Ajuvia for supine position

Timeframe: 1 night (approximately 8 hours)

Sensitivity of Ajuvia for prone position

Timeframe: 1 night (approximately 8 hours)

Specificity of Ajuvia for prone position

Timeframe: 1 night (approximately 8 hours)

Sensitivity of Ajuvia for left tilt position

Timeframe: 1 night (approximately 8 hours)

Specificity of Ajuvia for left tilt position

Timeframe: 1 night (approximately 8 hours)

Sensitivity of Ajuvia for left lateral position

Timeframe: 1 night (approximately 8 hours)

Trial details

NCT IDNCT04437407

SponsorShiphrah Biomedical Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-10

View on ClinicalTrials.gov More Stillbirth trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Sensitivity of Ajuvia for supine position

Timeframe: 1 night (approximately 8 hours)

Specificity of Ajuvia for supine position

Timeframe: 1 night (approximately 8 hours)

Sensitivity of Ajuvia for prone position

Timeframe: 1 night (approximately 8 hours)

Specificity of Ajuvia for prone position

Timeframe: 1 night (approximately 8 hours)

Sensitivity of Ajuvia for left tilt position

Timeframe: 1 night (approximately 8 hours)

Specificity of Ajuvia for left tilt position

Timeframe: 1 night (approximately 8 hours)

Sensitivity of Ajuvia for left lateral position

Timeframe: 1 night (approximately 8 hours)