None listed
Conditions
Brief summary
This feasibility, randomised, open-label, parallel group study is to evaluate the safety and efficacy of TBB in reducing sacroiliac joint pain, lumbar spine pain, and symphysis pubic pain associated with third trimester pregnancy. 90 eligible participants will be randomised into either Group A, where they will use The Belly Bed, an advanced maternity airbed, until delivery; or Group B, where they will use their own bed until delivery. Participants will be asked to complete surveys, including the Visual Analog Scale (VAS) to determine whether TBB helped reduce pain.
Interventions
The Belly Bed (TBB) is an advanced maternity airbed designed to provide relief for pregnancy related pain. TBB is divided into four different compartments, the main bed, abdominal cavity, head rest and leg rest which can be independently inflated and deflated by an internal air valve pump using a handheld remote control attached to the side of the bed. Once inflated, each compartment can be adjusted to accommodate the user’s need. The recessed abdominal cavity compartment can be adjusted to acco
The Belly Bed (TBB) is an advanced maternity airbed designed to provide relief for pregnancy related pain. TBB is divided into four different compartments, the main bed, abdominal cavity, head rest and leg rest which can be independently inflated and deflated by an internal air valve pump using a handheld remote control attached to the side of the bed. Once inflated, each compartment can be adjusted to accommodate the user’s need. The recessed abdominal cavity compartment can be adjusted to accommodate different sizes of the growing abdomen throughout pregnancy. The abdominal cavity compartment is filled by a cavity feather pillow. Participants can use their own pillow Eligible participants will be randomised 1:1 into either Group A, where they will be required to sleep on TBB from 27-32-week gestation until delivery; or Group B, where participants will be required to sleep on their own bed until delivery. TBB will be allocated to the participant by the site/birth centre along with instructions on how to use the bed. The study coordinator will be on hand to answer any questions the participant may have. Only the participant may sleep on TBB each night until delivery. All participants will be provided with a participant sleep diary which participants will be required to complete daily until the 38-weeks gestation follow-up visit. The sleep diary will include the time spent on the bed, sleeping positions among other questions. Participants will be required to bring their sleep diary with them at each study visit for it to be reviewed. If at any time the participant is unable to return the sleep diary, all attempts must be made to retrieve the diary from the participant. Participants will complete pain questionnaires during baseline and follow-up. Participants will be followed up at clinic visits at weeks 2, 4 and 6 after randomisation, and at 38-week gestation. A fetal ultrasound and Doppler will be conducted at baseline and 36-weeks of gestation. Delivery data will be collected from the participant's medical records. The participants will be followed up by phone for an end of study (EOS) visit 30 days after delivery for safety, at which point the participant will be considered to have completed the study.
Sponsors
The Belly Bed Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet all the following criteria for inclusion in the study: 1. Are willing and able to provide voluntary, written, and signed informed consent prior to any screening procedures and are willing to comply study protocol and its procedures. 2. Adult (greater than or equal to 18 years old) pregnant females. 3. At 27-32-week gestation have a documented history of pregnancy-related sacroiliac joint pain and/or, lumbar spine pain and/or symphysis pubic pain. 4. Pregnancy-related pain. 5. Current singleton pregnancy. 6. Have an adequate space to place and fully inflate TBB at their home and would be comfortable sleeping on an airbed-style bed.
Exclusion criteria
Participants must be excluded from the study if they meet one or more of the following criteria: 1. Any known condition that would not allow the participant to complete the trial treatment period (a minimum of 4-6-weeks from randomisation). 2. Body weight > 180 kg. 3. Height >198 cm. 4. Non-English speaking or inability to fully understand and read English. 5. Current use of illicit drugs. 6. Current use of opiates or medications containing opiates (except for codeine-based medication). 7. Known current cholestasis. 8. Diagnosed with sleep disorder(s) or condition(s) (e.g. insomnia, obstructive sleep apnoea) requiring sleep medication and/or treatment at the current pregnancy. 9. Planned child delivery outside the site/birth centre. 10. History of fractured pelvis and/or spinal injury. 11. History of or current rheumatoid arthritis or other forms of arthritis. 12. The investigator has deemed that birth prior to 38 weeks is likely. 13. Participating in other pregnancy pain clinical trial. 14. Any condition (physical, mental, psychological) that in the investigator judgement would impact on the suitability of the participant entering the study.
Outcome results
None listed