Please note: This trial has finished recruiting and is not accepting new participants.
Research Center: Royal North Shore Hospital
Location: Reserve Rd, St Leonards NSW 2065, Australia
Lead Researchers: Professor Jonathan Morris,  Dr. Sean Seeho
HREC Committee: This study has been reviewed and approved by the Human Research Ethics Committee of Northern Sydney Local Health District 2020/ETH00916

Background

According to SleepFoundation.org, a good night’s sleep is essential for both the mother and the baby’s health. During pregnancy, the mother can experience a wide range of challenges, like nausea, heartburn, backache, and night sweats, that make sleep difficult. The need for pregnant women to find a mattress that could help to relieve or reduce these symptoms can influence the quality of sleep they get.

The purpose of this study is to evaluate the safety and effectiveness of the Belly Bed when used by pregnant women who are in their third trimester and have experienced pain during this pregnancy such as sacroiliac joint pain, lumbar spine pain, and/or symphysis pubic pain. The Belly Bed has not been approved by the Therapeutic Goods Administration (TGA) as a treatment for pregnancy-related pain in Australia. However, the device has been on the commercial market as a potential device to help provide pregnancy-related pain relief. 

Interested participants must be pregnant women who are 18 years old and above. Participants must be willing to comply with all the study requirements for over approximately 3 months.   

Why Participate? 

• You may experience potential pregnancy-related pain relief.
• You may experience improvements to the quality of your sleep.
• You may contribute valuable information that may help other pregnant women.  
• You will be helping to advance research on sleep and pregnancy.

Your Rights

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you may withdraw at any time.
• Your records relating to this study and any other information received will be kept strictly confidential, except as required by the law.
• Qualified health professionals will monitor your health as it relates to the study.

Who Can Participate?

• Pregnant women aged 18 years old or older who are currently in their third trimester.
  • Third trimester means you are between 27-32 weeks pregnant

• Must have a history of pregnancy-related sacroiliac joint pain, lumbar spine pain and/or symphysis pubic pain.
• Must be able to comply with the following study requirements for over approximately 3 months:
  • Attend 5 study visits (these visits will be spaced 2 weeks apart) 
  • Potentially attend an ultrasound visit at 36 weeks of gestation
  • Attend an end of phone call study visit 30 days after delivery

Please note:

Due to the current situation with COVID-19 pandemic, the study team would like to point out the following:

• The research site does not treat COVID-19 patients and/or suspected COVID-19 patients.
• The research site’s waiting area is spacious enough that participants will not be within close proximity to each other.
• Hand sanitisers are available at the research site.
• The research staff adheres to strict hygienic practices as well as other safety measures to prevent the spread of COVID-19. 
• Any staff suspected to have COVID-19, or has come into contact with someone who has COVID-19, will automatically undergo a voluntary quarantine for 14 days.
• Interested participants will not be left waiting for a long period of time and will be quickly attended to. 
• Parking is available at the research site.
• The study team encourages the use of personal vehicles, taxi or rideshare services rather than public transit. 
• The research site/institution is taking all precautionary measures to ensure the safety of the study participants.