UniSA BackOff! Study: Adelaide PrenaBelt Trial

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.

Conditions

• Stillbirth
• Infant, Low Birth Weight
• Infant, Very Low Birth Weight
• Sleep-Disordered Breathing
• Infant, Small for Gestational Age
• Fetal Hypoxia
• Pregnancy Complications
• Fetal Growth Retardation

Interventions

DEVICE

PB2-1 prototype

PB2-1 prototype is a belt-like wearable device similar to the original PrenaBelt designed for pregnant women that permits supine positioning of the pelvis but, when in this position, provides subtle pressure points to the user's body and thereby activates the body's natural mechanism to reposition itself to relieve discomfort. It is expected to significantly decrease the amount of time a pregnant woman's pelvis is in the supine position overnight while promoting comfortable sleep.

DEVICE

PB2-2 prototype

PB2-2 prototype is a belt-like wearable device designed for pregnant women. When placed on the woman's back, this device prevents the pelvis from achieving a supine orientation by maintaining at least fifteen degrees of right or left lateral pelvic tilt. It is expected to significantly decrease the amount of time a pregnant woman's pelvis is in the supine position overnight while promoting comfortable sleep.

DEVICE

PB2-3 prototype

PB2-3 prototype is a belt-like wearable device designed for pregnant women. When placed on the woman's back, this device prevents the pelvis from achieving a supine orientation by maintaining at least fifteen degrees of right or left lateral pelvic tilt. It is expected to significantly decrease the amount of time a pregnant woman's pelvis is in the supine position overnight while promoting comfortable sleep.

DEVICE

PB2-4 prototype

PB2-4 prototype is a belt-like wearable device designed for pregnant women that prevents the user from achieving a supine position as the device allows right and left lateral pelvic tilt but prevents the user's pelvis from settling supine due to virtue of its design. It is expected to significantly decrease the amount of time a pregnant woman's pelvis is in the supine position overnight while promoting comfortable sleep.

DEVICE

PB2-5 prototype

PB2-5 prototype is a belt-like wearable device designed for pregnant women that does not provide positional therapy. It can be worn anytime as a maternity support belt.

DEVICE

Ajuvia-Active

Ajuvia Sleep Monitor senses the user's body position and can be used in passive or active mode with or without the PB2 prototypes. In the active mode, it alerts the woman when her pelvis is in the supine position through a gentle vibratory alarm.

DEVICE

Ajuvia-Passive

Ajuvia Sleep Monitor senses the user's body position and can be used in passive or active mode with or without the PB2 prototypes. In the passive mode, it measures and records the position of the pelvis but does not alert the woman.

Sponsors & Collaborators

• University of South Australia

  collaborator OTHER

• Shiphrah Biomedical Inc.

  lead INDUSTRY

Principal Investigators

• Jane Warland, PhD · University of South Australia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-02-01

Primary Completion

2021-06-10

Completion

2021-06-15

Countries

• Australia

Study Locations