Stopped: Participant dropout and technical difficulties
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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Specificity of Ajuvia for left lateral position
Timeframe: 1 night (approximately 8 hours)
Sensitivity of Ajuvia for right tilt position
Timeframe: 1 night (approximately 8 hours)
Specificity of Ajuvia for right tilt position
Timeframe: 1 night (approximately 8 hours)
Sensitivity of Ajuvia for right lateral position
Timeframe: 1 night (approximately 8 hours)
Specificity of Ajuvia for right lateral position
Timeframe: 1 night (approximately 8 hours)
Supine Sleep Time - Control
Timeframe: 1 night (approximately 8 hours)
Supine Sleep Time - PB2-1
Timeframe: 1 night (approximately 8 hours)
Supine Sleep Time - PB2-2
Timeframe: 1 night (approximately 8 hours)
Supine Sleep Time - PB2-3
Timeframe: 1 night (approximately 8 hours)
Supine Sleep Time - PB2-4
Timeframe: 1 night (approximately 8 hours)
Supine Sleep Time - PB2-5
Timeframe: 1 night (approximately 8 hours)
Prone Sleep Time - Control
Timeframe: 1 night (approximately 8 hours)
Prone Sleep Time - PB2-1
Timeframe: 1 night (approximately 8 hours)
Prone Sleep Time - PB2-2
Timeframe: 1 night (approximately 8 hours)
Prone Sleep Time - PB2-3
Timeframe: 1 night (approximately 8 hours)
Prone Sleep Time - PB2-4
Timeframe: 1 night (approximately 8 hours)
Prone Sleep Time - PB2-5
Timeframe: 1 night (approximately 8 hours)
Left-tilt Sleep Time - Control
Timeframe: 1 night (approximately 8 hours)
Left-tilt Sleep Time - PB2-1
Timeframe: 1 night (approximately 8 hours)
Left-tilt Sleep Time - PB2-2
Timeframe: 1 night (approximately 8 hours)
Left-tilt Sleep Time - PB2-3
Timeframe: 1 night (approximately 8 hours)
Left-tilt Sleep Time - PB2-4
Timeframe: 1 night (approximately 8 hours)
Left-tilt Sleep Time - PB2-5
Timeframe: 1 night (approximately 8 hours)
Left-lateral Sleep Time - Control
Timeframe: 1 night (approximately 8 hours)
Left-lateral Sleep Time - PB2-1
Timeframe: 1 night (approximately 8 hours)
Left-lateral Sleep Time - PB2-2
Timeframe: 1 night (approximately 8 hours)
Left-lateral Sleep Time - PB2-3
Timeframe: 1 night (approximately 8 hours)
Left-lateral Sleep Time - PB2-4
Timeframe: 1 night (approximately 8 hours)
Left-lateral Sleep Time - PB2-5
Timeframe: 1 night (approximately 8 hours)
Right-tilt Sleep Time - Control
Timeframe: 1 night (approximately 8 hours)
Right-tilt Sleep Time - PB2-1
Timeframe: 1 night (approximately 8 hours)
Right-tilt Sleep Time - PB2-2
Timeframe: 1 night (approximately 8 hours)
Right-tilt Sleep Time - PB2-3
Timeframe: 1 night (approximately 8 hours)
Right-tilt Sleep Time - PB2-4
Timeframe: 1 night (approximately 8 hours)
Right-tilt Sleep Time - PB2-5
Timeframe: 1 night (approximately 8 hours)
Right-lateral Sleep Time - Control
Timeframe: 1 night (approximately 8 hours)
Right-lateral Sleep Time - PB2-1
Timeframe: 1 night (approximately 8 hours)
Right-lateral Sleep Time - PB2-2
Timeframe: 1 night (approximately 8 hours)
Right-lateral Sleep Time - PB2-3
Timeframe: 1 night (approximately 8 hours)
Right-lateral Sleep Time - PB2-4
Timeframe: 1 night (approximately 8 hours)
Right-lateral Sleep Time - PB2-5
Timeframe: 1 night (approximately 8 hours)