Please be advised that due to the high volume of submissions, the ANZCTR is currently experiencing delays in processing submissions from those outside of Australia and New Zealand. As the ANZCTR is funded by Australia and New Zealand, we must prioritise submissions from these countries first. International submissions should allow additional time for registration. Apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001256167
Ethics application status
Approved
Date submitted
9/07/2019
Date registered
11/09/2019
Date last updated
11/09/2019
Date data sharing statement initially provided
11/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Feasibility, Randomised, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of The Belly Bed (TBB) in Reducing Sacroiliac Joint Pain, Lumbar Spine Pain, and Symphysis Pubic Pain Associated with Third Trimester Pregnancy
Scientific title
A Feasibility, Randomised, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of The Belly Bed (TBB) in Reducing Sacroiliac Joint Pain, Lumbar Spine Pain, and Symphysis Pubic Pain Associated with Third Trimester Pregnancy
Secondary ID [1] 298422 0
TBB-CIP-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sacroiliac Joint Pain 313151 0
Lumbar Spine Pain 313152 0
Symphysis Pubic Pain 313153 0
Condition category
Condition code
Reproductive Health and Childbirth 311621 311621 0 0
Antenatal care
Musculoskeletal 311622 311622 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 314675 0
Treatment: Devices
Comparator / control treatment
The comparator group will be Group B, participants who have been randomised to sleep on their own bed until delivery.
Control group
Active

Outcomes
Primary outcome [1] 320321 0
Change from overall baseline pain scores using VAS (overall VAS is defined as VAS from the sacroiliac and lumbar spine and pubic symphysis region).
Timepoint [1] 320321 0
Change in overall VAS will be measured at Day 0 (27-32-weeks gestation) and weeks 2, 4, 5 and 38-weeks gestation, or if delivery occurs earlier, the prior study visit.
Secondary outcome [1] 371235 0
Assessment of device related adverse events. Participants will be asked to list any adverse events in their sleep diary and the site will enquire for adverse events during follow up appointments. There are no known, relevant adverse events expected for participants using the TBB.
Timepoint [1] 371235 0
38-weeks gestation, or if delivery occurs earlier, the last completed visit (4-week or 6-week visit). Visits are conducted fortnightly from baseline/randomisation.
Secondary outcome [2] 371236 0
Change in sacroiliac pain VAS score from baseline.
Timepoint [2] 371236 0
38-weeks gestation, or if delivery occurs earlier, the last completed visit (4-week or 6-week visit). Visits are conducted fortnightly from baseline/randomisation.
Secondary outcome [3] 371237 0
Change in lumbar spine pain VAS from baseline.
Timepoint [3] 371237 0
38-weeks gestation, or if delivery occurs earlier, the last completed visit (4-week or 6-week visit). Visits are conducted fortnightly from baseline/randomisation.
Secondary outcome [4] 371238 0
Change in symphysis pubic pain VAS from baseline.
Timepoint [4] 371238 0
38-weeks gestation, or if delivery occurs earlier, the last completed visit (4-week or 6-week visit). Visits are conducted fortnightly from baseline/randomisation.
Secondary outcome [5] 371239 0
Change in leg pain VAS from baseline.
Timepoint [5] 371239 0
38-weeks gestation, or if delivery occurs earlier, the last completed visit (4-week or 6-week visit). Visits are conducted fortnightly from baseline/randomisation.
Secondary outcome [6] 371240 0
Change in oedema score from baseline measured using pitting oedema measurement scale;
a. 1+ - 2mm depression, barely detectable. Immediate rebound.
b. 2+ - 4mm deep pit. A few seconds to rebound.
c. 3+ - 6mm deep pit. 10-12 seconds to rebound.
d. 4+ - 8mm very deep pit. >20 seconds to rebound.
Timepoint [6] 371240 0
38-weeks gestation, or if delivery occurs earlier, the last completed visit (4-week visit or 6-week visit). Visits are conducted fortnightly from baseline/randomisation.
Secondary outcome [7] 371241 0
Change in baseline blood pressure measurement. Blood pressure is measured at each visit (every two weeks from baseline) using a blood pressure cuff (sphygmomanometer).
Timepoint [7] 371241 0
38-weeks gestation, or if delivery occurs earlier, the last completed visit (4-week or 6-week visit). Visits are conducted fortnightly from baseline/randomisation.
Secondary outcome [8] 371242 0
Change in baseline assessment of quality of life (AQol-8D).
Timepoint [8] 371242 0
38-weeks gestation, or if delivery occurs earlier, the last completed visit (4-week or 6-week visit). Visits are conducted fortnightly from baseline/randomisation.
Secondary outcome [9] 371243 0
Change in baseline Likert scale (composite secondary outcome) of 0 (never affected) to 10 (always affected), related to pain in six (6) defined physical activities:
a. sleeping
b. getting up from a sitting position
c. sitting down
d. walking
e. working
f. overall daily life
Timepoint [9] 371243 0
38-weeks gestation, or if delivery occurs earlier, the last completed visit (4-week or 6-week visit). Visits are conducted fortnightly from baseline/randomisation.
Secondary outcome [10] 371244 0
Change in baseline parameters noted in the sleep diary. The parameters are daytime sleepiness, sleeping position preferences and ability to sleep in these positions, hours of continual sleep overnight, time spent on bed during the day, type of bed slept, adverse events and new or change in concomitant medication and therapy. Multiple parameters will be assessed as a composite outcome.
Timepoint [10] 371244 0
38-weeks gestation, or if delivery occurs earlier, the last completed visit (4-week or 6-week visit). Assessed during visits conducted fortnightly from baseline/randomisation.
Secondary outcome [11] 371245 0
Assessment of delivery data which includes, mode of delivery, requirement for Epidural use in labour, gestation, birth weight, Apgar score at five minutes. Data will be assessed as a composite outcome. Information will be collected from the participant's medical records.
Timepoint [11] 371245 0
Once off at 38-weeks gestation, or if delivery occurs earlier, the last completed visit (4-week or 6-week visit).
Secondary outcome [12] 371246 0
Change in pain medication, concomitant pain therapies and anti-hypertensive medication from baseline to final follow-up visit. To be assessed as a composite outcome. Changes in pain medication, anti-hypertensive medication and pain therapies will be assessed from participant's medical records, via the participant's sleep diary and by asking the participants directly.
Timepoint [12] 371246 0
38-weeks gestation, or if delivery occurs earlier, the last completed visit (4-week or 6-week visit). Assessed fortnightly after baseline up to and including delivery, followed by a final end of study phone visit 30 days post delivery.
Secondary outcome [13] 371247 0
Fetal growth measurements (to be assessed as a composite outcome) comparison from baseline to 36-week gestation by ultrasound of the following;
a. Biparietal Diameter (BD)
b. Head Circumference (HC)
c. Abdominal Circumference (AC)
d. Femur Length (FL)
e. Estimated Fetal Weight (EFW)
f. Umbilical Artery Doppler (UAD)
g. Amniotic Fluid Index (AFI)
Timepoint [13] 371247 0
38-weeks gestation, or if delivery occurs earlier, the last completed visit (4-week or 6-week visit). Assessed fortnightly after baseline up to and including delivery, followed by a final end of study phone visit 30 days post delivery.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be completed in a 1:1 allocation ratio to group A (TBB) or group B (own bed) via computer generated randomisation. Randomisation will only occur when the screened participant strictly meets all the study eligibility criteria. Randomisation will occur using two strata;
1. 27 weeks +0 day to 29 weeks +6 days gestation
2. Greater than or equal to 30 weeks +0 day to 32 weeks +6 days gestation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
A sample size of 90 (45 participants per group) will provide 80% power to detect a reduction in pain score of 1.5 VAS points (assuming SD equal to 2.5, alpha equal to 0.05 and a 2-sided t-test is used). Therefore, up to 100 participants will be included in the study to allow for drop outs.

The primary efficacy variable is the change from overall baseline VAS compared with VAS at 38-weeks gestation (if the participant births early the last completed visit; either week 4 or week 6).

The change from baseline at time X will be calculated as the VAS score at time X minus the VAS score at Day 0, where x equal to 2, 4, 6 weeks and 38-weeks gestation (endpoint). Change from baseline to all follow-up assessment visits will be calculated in a similar way.
Standard summary statistics for VAS values and the change from baseline will be presented. A plot of mean scores over time will be presented. The plot will clearly show the bed in use at the time.

A mixed model will be used to evaluate the change from baseline for TBB compared with usual bed. The model will be fitted using SAS PROC MIXED. The baseline mean VAS score will be included as a covariate in the model. From the model the change in VAS on TBB compared with own bed will be estimated and presented with 95% confidence limits. A p-value for the hypothesis test H0: change in VAS for TBB = own bed against the alternative (H1): the change in VAS for TBB in not equal to a change in VAS for own bed will be presented.

Secondary objectives
All VAS for pain, the 11-point (0-10) Likert scales for specific activities, and the AQoL will be analysed as described for the primary endpoint.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13940 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 13941 0
North Shore Private Hospital - St Leonards
Recruitment postcode(s) [1] 26709 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 302974 0
Commercial sector/Industry
Name [1] 302974 0
The Belly Bed Pty Ltd
Address [1] 302974 0
PO Box 714
Rose Bay NSW 2029 Australia
Country [1] 302974 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
The Belly Bed Pty Ltd
Address
PO Box 714
Rose Bay NSW 2029
Australia
Country
Australia
Secondary sponsor category [1] 303189 0
None
Name [1] 303189 0
Address [1] 303189 0
Country [1] 303189 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303526 0
Northern Sydney Local Health District HREC
Ethics committee address [1] 303526 0
Kolling Building
Level 13
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 303526 0
Australia
Date submitted for ethics approval [1] 303526 0
06/07/2018
Approval date [1] 303526 0
24/10/2018
Ethics approval number [1] 303526 0
RESP/18/164

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93966 0
Prof Jonathon Morris
Address 93966 0
North Shore Private Hospital
Suite 8, Level 3,
3 Westbourne Street,
St Leonards, NSW, 2065
Country 93966 0
Australia
Phone 93966 0
+61 2 9436 2129
Fax 93966 0
Email 93966 0
jonathan.morris@sydney.edu.au
Contact person for public queries
Name 93967 0
Mr Stefan Czyniewski
Address 93967 0
Mobius Medical Pty Ltd
Suite 401
275 Alfred St
North Sydney, NSW 2060
Country 93967 0
Australia
Phone 93967 0
+61 2 8317 5460
Fax 93967 0
+ 61 2 8317 5461
Email 93967 0
stefan@mobiusmedical.com.au
Contact person for scientific queries
Name 93968 0
Prof Jonathon Morris
Address 93968 0
North Shore Private Hospital
Suite 8, Level 3,
3 Westbourne Street,
St Leonards, NSW, 2065
Country 93968 0
Australia
Phone 93968 0
+61 2 9436 2129
Fax 93968 0
Email 93968 0
jonathan.morris@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant privacy. Data will be analysed and disseminated in peer reviewed journals and potentially podium presentations. Data will be anonymised and presented collectively.
What supporting documents are/will be available?
Informed consent form
How or where can supporting documents be obtained?
Type [1] 4020 0
Informed consent form
Citation [1] 4020 0
Link [1] 4020 0
Email [1] 4020 0
Other [1] 4020 0
TBB-CIP-01 Master PICF V2.0 dated 9 Aug 2018
Summary results
No Results