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Trial registered on ANZCTR


Registration number
ACTRN12617000268347
Ethics application status
Approved
Date submitted
15/02/2017
Date registered
22/02/2017
Date last updated
27/11/2019
Date data sharing statement initially provided
27/11/2019
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 Scaroiliac 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 Scaroiliac Joint Pain, Lumbar Spine Pain, and Symphysis Pubic Pain Associated with Third Trimester Pregnancy
Secondary ID [1] 291144 0
NIL
Universal Trial Number (UTN)
Trial acronym
TBB-CIP-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy Related Sacroiliac Joint Pain 301992 0
Pregnancy Related Lumbar Spine Pain 302146 0
Pregnancy Related Symphysis Pubic Pain 302147 0
Condition category
Condition code
Reproductive Health and Childbirth 301633 301633 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Belly Bed is an advanced maternity airbed manufactured by The Belly Bed Pty Ltd designed to provide relief for pregnancy related pain. It is divided into three different compartments (the main bed, abdominal cavity and leg rest) which can be independently inflated by internal electronic air valve pump to accommodate user's need. The recessed abdominal compartment may be adjusted to accommodate different size of the growing abdomen throughout pregnancy.

A open-label, parallel group study design whereby each participant is randomised in 1:1 ratio into Group A and Group B whereby Group A uses TBB while Group B continues to use their own Bed until delivery of the child.

Participants are anticipated to use either TBB or their own Bed until the delivery of the child. Participants will be required to complete Participant Diary every day following Baseline Visit and these diaries will be monitored to ensure participant's adherence to the intervention as per the study protocol.

Participants are required to complete questionnaires on pain and quality of life and physical examination and vital signs will be performed during their routine Follow Up Visits (as part of the study) to assess the health of the participants and be monitored for any abnormalities.

The dimension of fully inflated TBB is 198 centimetres by 117 centimetres by 55 centimetres and it supports up to 220 kilograms of net weight. Instruction Manual will be provided to the participants to instruct them on safe usage of TBB.
Intervention code [1] 297127 0
Treatment: Devices
Comparator / control treatment
Control Treatment is Group B Participant's own Bed.
Control group
Active

Outcomes
Primary outcome [1] 301034 0
Change from baseline in mean overall Visual Analog Scale (VAS) score for overall pain incorporating the sacroiliac joint, lumbar spine, and pubic symphysis after 4 weeks use of TBB compared with own Bed.
Timepoint [1] 301034 0
Baseline, Week 2, Week 4
Secondary outcome [1] 331529 0
Change from baseline in mean overall Visual Analog Scale (VAS) score for sacroiliac joint pain, lumbar spine pain, pubic symphysis and leg pain after 4 weeks use of TBB compared with own Bed.
Timepoint [1] 331529 0
Baseline, Week 2, Week 4
Secondary outcome [2] 331532 0
Change from baseline in assessment of quality of life after 4 weeks use of TBB compared with own bed. This outcome will be assessed using Assessment of Quality of Life (AQoL-8D) questionnaire.
Timepoint [2] 331532 0
Baseline, Week 2, Week 4
Secondary outcome [3] 331533 0
Changes from baseline in blood pressure measurement after 4 weeks use of TBB compared with own bed.
Timepoint [3] 331533 0
Baseline, Week 2, Week 4
Secondary outcome [4] 331534 0
Changes in oedema after 4 weeks use of TBB compared with own bed. This outcome will be assessed using pitting odema measurement scale (four-point grading scale).
Timepoint [4] 331534 0
Baseline, Week 2, Week 4
Secondary outcome [5] 331535 0
Changes from baseline in Likert Scale of 0 to 10 related to pain from sleeping after 4 weeks use of TBB Compared with own bed.
Timepoint [5] 331535 0
Baseline, Week 2, Week 4
Secondary outcome [6] 331887 0
Changes from baseline in Likert Scale of 0 to 10 related to pain from getting up from a sitting position after 4 weeks use of TBB Compared with own bed.
Timepoint [6] 331887 0
Baseline, Week 2, Week 4
Secondary outcome [7] 331888 0
Changes from baseline in Likert Scale of 0 to 10 related to pain from sitting down after 4 weeks use of TBB Compared with own bed.
Timepoint [7] 331888 0
Baseline, Week 2, Week 4
Secondary outcome [8] 331889 0
Changes from baseline in Likert Scale of 0 to 10 related to pain from walking after 4 weeks use of TBB Compared with own bed.
Timepoint [8] 331889 0
Baseline, Week 2, Week 4
Secondary outcome [9] 331890 0
Changes from baseline in Likert Scale of 0 to 10 related to pain from working after 4 weeks use of TBB Compared with own bed.
Timepoint [9] 331890 0
Baseline, Week 2, Week 4
Secondary outcome [10] 331891 0
Changes from baseline in Likert Scale of 0 to 10 related to pain from overall daily life after 4 weeks use of TBB Compared with own bed.
Timepoint [10] 331891 0
Baseline, Week 2, Week 4

Eligibility
Key inclusion criteria
1. Are willing and able to provide voluntary, written and signed informed consent prior to any screening procedures.
2. Adult (greater than or equal to 18 years old) pregnant females.
3. At greater than or equal to 32 week's gestation at the time of screening with documented history of sacroiliac joint pain, lumbar spine pain, and symphysis pubic pain for at least 4 weeks prior to screening.
4. Have moderate to unbearable pain assessed for sacroiliac joint pain, lumbar spine pain and symphysis pubic pain at screening
5. Current singleton-pregnancy
6. Have an adequate space of 198 cm x 117 cm x 55 cm to place and fully inflate TBB at their home.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any known condition that would not allow the participants to complete the trial treatment period (a minimum of 4 weeks from screening).
2. Body weight > 180 kg
3. Non-English speaking or inability to fully understand and read English.
4. Blood pressure greater than 160/100 mm Hg or uncontrolled blood pressure.
5. Have any past or current history of any substance abuse (including alcohol).
6. Current use of opiates or medication containing opiates.
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. Current or previous smoker (previous defined as < 12 months or a > 20-year pack history)
11. History of fractured pelvis and/or spinal injury.
12. History of or current rheumatoid arthritis or similar condition.
13. Current or history of (previous) pregnancy complications.
14. Participating in other pregnancy pain clinical trial.
15. Any condition (physical, mental, psychological) that in the investigator's 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)
Each participant will be identified by screening number. The screening number will be issued once the participant has given written consent to participate in the study. Once the participant is deemed eligible and enrolled into the study, they will be randomly allocated into Group A or Group B.

The order of allocation will be determined by sealed opaque envelope that will contain information on the Group that they are assigned to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation list will be prepared using a computer program for a balanced parallel design.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
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,VIC

Funding & Sponsors
Funding source category [1] 295581 0
Commercial sector/Industry
Name [1] 295581 0
The Belly Bed Pty Ltd
Address [1] 295581 0
PO Box 714
Rosebay, NSW, 2029
Country [1] 295581 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
The Belly Bed Pty Ltd
Address
PO Box 714
Rosebay, NSW, 2029
Country
Australia
Secondary sponsor category [1] 294412 0
None
Name [1] 294412 0
Address [1] 294412 0
Country [1] 294412 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296903 0
Northern Sydney Local Health District
Ethics committee address [1] 296903 0
Kolling Institute, Level 13 Kolling Building, Royal North Shore Hospital, St Leonards, NSW, 2065
Ethics committee country [1] 296903 0
Australia
Date submitted for ethics approval [1] 296903 0
27/02/2017
Approval date [1] 296903 0
22/10/2018
Ethics approval number [1] 296903 0
RESP/18/164Study

Summary
Brief summary
This is an open-label, parallel group study assessing the therapeutic effects of the Belly Bed in participants suffering from sacroiliac joint pain, lumbar spine pain and symphysis pubic pain associated with third trimester pregnancy. Participant will be randomised to use the Belly Bed or own Bed. Changes in pain associated with sacroiliac joint, and lumbar spine, and symphysis pubic in third trimester will be assess by Visual Analog Scale after 4 weeks of treatment compared to baseline.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72382 0
Prof Jonathan Morris
Address 72382 0
Building 52, Level 2
Royal North Shore Hospital
St Leonards, NSW, 2065
Country 72382 0
Australia
Phone 72382 0
+61 2 9463 1533
Fax 72382 0
Email 72382 0
jonathan.morris@sydney.edu.au
Contact person for public queries
Name 72383 0
Mr Stefan Czyniewski
Address 72383 0
Mobius Medical Pty Ltd, Suite 1402B, 275 Alfred Street, North Sydney, NSW. 2060
Country 72383 0
Australia
Phone 72383 0
+61 2 8317 5460
Fax 72383 0
+61 2 8317 5461
Email 72383 0
stefan@mobiusmedical.com.au
Contact person for scientific queries
Name 72384 0
Prof Jonathan Morris
Address 72384 0
Building 52, Level 2
Royal North Shore Hospital
St Leonards, NSW, 2065
Country 72384 0
Australia
Phone 72384 0
+61 2 9463 1533
Fax 72384 0
Email 72384 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
Not required
What supporting documents are/will be available?
No other documents available
Summary results
No Results