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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04437407




Registration number
NCT04437407
Ethics application status
Date submitted
16/06/2020
Date registered
18/06/2020
Date last updated
2/09/2021

Titles & IDs
Public title
UniSA BackOff! Study: Adelaide PrenaBelt Trial
Scientific title
UniSA BackOff! Study: A Randomized, Controlled, Five-way, Cross-over Trial to Evaluate the Effect of a Positional Therapy Device on Maternal Sleeping Position in the Third Trimester of Pregnancy
Secondary ID [1] 0 0
202902
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stillbirth 0 0
Infant, Low Birth Weight 0 0
Infant, Very Low Birth Weight 0 0
Sleep-Disordered Breathing 0 0
Infant, Small for Gestational Age 0 0
Fetal Hypoxia 0 0
Pregnancy Complications 0 0
Fetal Growth Retardation 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - PB2-1 prototype
Treatment: Devices - PB2-2 prototype
Treatment: Devices - PB2-3 prototype
Treatment: Devices - PB2-4 prototype
Treatment: Devices - PB2-5 prototype
Treatment: Devices - Ajuvia-Active
Treatment: Devices - Ajuvia-Passive

Other: Control - The first night will be a control night with infrared video recording where only the Ajuvia sleep monitor is worn in passive mode so that each participant can act as her own control for comparison of treatment effect on outcomes.

Experimental: PB2-1 - During this night, the PB2-1 prototype will be worn with the Ajuvia in passive mode.

Experimental: PB2-2 - During this night, the PB2-2 prototype will be worn with the Ajuvia in passive mode.

Experimental: PB2-3 - During this night, the PB2-3 prototype will be worn with the Ajuvia in passive mode.

Experimental: PB2-4 - During this night, the PB2-4 prototype will be worn with the Ajuvia in passive mode.

Experimental: PB2-5 - During this night, the PB2-5 prototype will be worn with the Ajuvia in active mode.


Treatment: Devices: 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.

Treatment: Devices: 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.

Treatment: Devices: 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.

Treatment: Devices: 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.

Treatment: Devices: 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.

Treatment: Devices: 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.

Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sensitivity of Ajuvia for supine position
Timepoint [1] 0 0
1 night (approximately 8 hours)
Primary outcome [2] 0 0
Specificity of Ajuvia for supine position
Timepoint [2] 0 0
1 night (approximately 8 hours)
Primary outcome [3] 0 0
Sensitivity of Ajuvia for prone position
Timepoint [3] 0 0
1 night (approximately 8 hours)
Primary outcome [4] 0 0
Specificity of Ajuvia for prone position
Timepoint [4] 0 0
1 night (approximately 8 hours)
Primary outcome [5] 0 0
Sensitivity of Ajuvia for left tilt position
Timepoint [5] 0 0
1 night (approximately 8 hours)
Primary outcome [6] 0 0
Specificity of Ajuvia for left tilt position
Timepoint [6] 0 0
1 night (approximately 8 hours)
Primary outcome [7] 0 0
Sensitivity of Ajuvia for left lateral position
Timepoint [7] 0 0
1 night (approximately 8 hours)
Primary outcome [8] 0 0
Specificity of Ajuvia for left lateral position
Timepoint [8] 0 0
1 night (approximately 8 hours)
Primary outcome [9] 0 0
Sensitivity of Ajuvia for right tilt position
Timepoint [9] 0 0
1 night (approximately 8 hours)
Primary outcome [10] 0 0
Specificity of Ajuvia for right tilt position
Timepoint [10] 0 0
1 night (approximately 8 hours)
Primary outcome [11] 0 0
Sensitivity of Ajuvia for right lateral position
Timepoint [11] 0 0
1 night (approximately 8 hours)
Primary outcome [12] 0 0
Specificity of Ajuvia for right lateral position
Timepoint [12] 0 0
1 night (approximately 8 hours)
Primary outcome [13] 0 0
Supine Sleep Time - Control
Timepoint [13] 0 0
1 night (approximately 8 hours)
Primary outcome [14] 0 0
Supine Sleep Time - PB2-1
Timepoint [14] 0 0
1 night (approximately 8 hours)
Primary outcome [15] 0 0
Supine Sleep Time - PB2-2
Timepoint [15] 0 0
1 night (approximately 8 hours)
Primary outcome [16] 0 0
Supine Sleep Time - PB2-3
Timepoint [16] 0 0
1 night (approximately 8 hours)
Primary outcome [17] 0 0
Supine Sleep Time - PB2-4
Timepoint [17] 0 0
1 night (approximately 8 hours)
Primary outcome [18] 0 0
Supine Sleep Time - PB2-5
Timepoint [18] 0 0
1 night (approximately 8 hours)
Primary outcome [19] 0 0
Prone Sleep Time - Control
Timepoint [19] 0 0
1 night (approximately 8 hours)
Primary outcome [20] 0 0
Prone Sleep Time - PB2-1
Timepoint [20] 0 0
1 night (approximately 8 hours)
Primary outcome [21] 0 0
Prone Sleep Time - PB2-2
Timepoint [21] 0 0
1 night (approximately 8 hours)
Primary outcome [22] 0 0
Prone Sleep Time - PB2-3
Timepoint [22] 0 0
1 night (approximately 8 hours)
Primary outcome [23] 0 0
Prone Sleep Time - PB2-4
Timepoint [23] 0 0
1 night (approximately 8 hours)
Primary outcome [24] 0 0
Prone Sleep Time - PB2-5
Timepoint [24] 0 0
1 night (approximately 8 hours)
Primary outcome [25] 0 0
Left-tilt Sleep Time - Control
Timepoint [25] 0 0
1 night (approximately 8 hours)
Primary outcome [26] 0 0
Left-tilt Sleep Time - PB2-1
Timepoint [26] 0 0
1 night (approximately 8 hours)
Primary outcome [27] 0 0
Left-tilt Sleep Time - PB2-2
Timepoint [27] 0 0
1 night (approximately 8 hours)
Primary outcome [28] 0 0
Left-tilt Sleep Time - PB2-3
Timepoint [28] 0 0
1 night (approximately 8 hours)
Primary outcome [29] 0 0
Left-tilt Sleep Time - PB2-4
Timepoint [29] 0 0
1 night (approximately 8 hours)
Primary outcome [30] 0 0
Left-tilt Sleep Time - PB2-5
Timepoint [30] 0 0
1 night (approximately 8 hours)
Primary outcome [31] 0 0
Left-lateral Sleep Time - Control
Timepoint [31] 0 0
1 night (approximately 8 hours)
Primary outcome [32] 0 0
Left-lateral Sleep Time - PB2-1
Timepoint [32] 0 0
1 night (approximately 8 hours)
Primary outcome [33] 0 0
Left-lateral Sleep Time - PB2-2
Timepoint [33] 0 0
1 night (approximately 8 hours)
Primary outcome [34] 0 0
Left-lateral Sleep Time - PB2-3
Timepoint [34] 0 0
1 night (approximately 8 hours)
Primary outcome [35] 0 0
Left-lateral Sleep Time - PB2-4
Timepoint [35] 0 0
1 night (approximately 8 hours)
Primary outcome [36] 0 0
Left-lateral Sleep Time - PB2-5
Timepoint [36] 0 0
1 night (approximately 8 hours)
Primary outcome [37] 0 0
Right-tilt Sleep Time - Control
Timepoint [37] 0 0
1 night (approximately 8 hours)
Primary outcome [38] 0 0
Right-tilt Sleep Time - PB2-1
Timepoint [38] 0 0
1 night (approximately 8 hours)
Primary outcome [39] 0 0
Right-tilt Sleep Time - PB2-2
Timepoint [39] 0 0
1 night (approximately 8 hours)
Primary outcome [40] 0 0
Right-tilt Sleep Time - PB2-3
Timepoint [40] 0 0
1 night (approximately 8 hours)
Primary outcome [41] 0 0
Right-tilt Sleep Time - PB2-4
Timepoint [41] 0 0
1 night (approximately 8 hours)
Primary outcome [42] 0 0
Right-tilt Sleep Time - PB2-5
Timepoint [42] 0 0
1 night (approximately 8 hours)
Primary outcome [43] 0 0
Right-lateral Sleep Time - Control
Timepoint [43] 0 0
1 night (approximately 8 hours)
Primary outcome [44] 0 0
Right-lateral Sleep Time - PB2-1
Timepoint [44] 0 0
1 night (approximately 8 hours)
Primary outcome [45] 0 0
Right-lateral Sleep Time - PB2-2
Timepoint [45] 0 0
1 night (approximately 8 hours)
Primary outcome [46] 0 0
Right-lateral Sleep Time - PB2-3
Timepoint [46] 0 0
1 night (approximately 8 hours)
Primary outcome [47] 0 0
Right-lateral Sleep Time - PB2-4
Timepoint [47] 0 0
1 night (approximately 8 hours)
Primary outcome [48] 0 0
Right-lateral Sleep Time - PB2-5
Timepoint [48] 0 0
1 night (approximately 8 hours)

Eligibility
Key inclusion criteria
* =18 years old
* low-risk singleton pregnancy
* in the last trimester of pregnancy (at least 28 weeks + 0 days but not more than 36 weeks + 0 days of gestation)
* access to and ability to use iPhone (for downloading and using Ajuvia app)
* residing in the Greater Adelaide Area.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* musculoskeletal disorder that prevents sleeping supine or on a certain side (e.g., arthritic shoulder)
* non-English speaking and reading

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/06/2021
Sample size
Target
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
UniSA Clinical & Health Sciences - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shiphrah Biomedical Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of South Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT04437407
Trial related presentations / publications
Kember AJ, Scott HM, O'Brien LM, Borazjani A, Butler MB, Wells JH, Isaac A, Chu K, Coleman J, Morrison DL. Modifying maternal sleep position in the third trimester of pregnancy with positional therapy: a randomised pilot trial. BMJ Open. 2018 Aug 29;8(8):e020256. doi: 10.1136/bmjopen-2017-020256.
Coleman J, Okere M, Seffah J, Kember A, O'Brien LM, Borazjani A, Butler M, Wells J, MacRitchie S, Isaac A, Chu K, Scott H. The Ghana PrenaBelt trial: a double-blind, sham-controlled, randomised clinical trial to evaluate the effect of maternal positional therapy during third-trimester sleep on birth weight. BMJ Open. 2019 May 1;9(4):e022981. doi: 10.1136/bmjopen-2018-022981.
Cronin RS, Li M, Thompson JMD, Gordon A, Raynes-Greenow CH, Heazell AEP, Stacey T, Culling VM, Bowring V, Anderson NH, O'Brien LM, Mitchell EA, Askie LM, McCowan LME. An Individual Participant Data Meta-analysis of Maternal Going-to-Sleep Position, Interactions with Fetal Vulnerability, and the Risk of Late Stillbirth. EClinicalMedicine. 2019 Apr 2;10:49-57. doi: 10.1016/j.eclinm.2019.03.014. eCollection 2019 Apr.
O'Brien LM, Warland J, Stacey T, Heazell AEP, Mitchell EA; STARS Consortium. Maternal sleep practices and stillbirth: Findings from an international case-control study. Birth. 2019 Jun;46(2):344-354. doi: 10.1111/birt.12416. Epub 2019 Jan 18.
Anderson NH, Gordon A, Li M, Cronin RS, Thompson JMD, Raynes-Greenow CH, Heazell AEP, Stacey T, Culling VM, Wilson J, Askie LM, Mitchell EA, McCowan LME. Association of Supine Going-to-Sleep Position in Late Pregnancy With Reduced Birth Weight: A Secondary Analysis of an Individual Participant Data Meta-analysis. JAMA Netw Open. 2019 Oct 2;2(10):e1912614. doi: 10.1001/jamanetworkopen.2019.12614.
Warland J, Dorrian J, Morrison JL, O'Brien LM. Maternal sleep during pregnancy and poor fetal outcomes: A scoping review of the literature with meta-analysis. Sleep Med Rev. 2018 Oct;41:197-219. doi: 10.1016/j.smrv.2018.03.004. Epub 2018 Mar 27.
Warland J, Dorrian J, Kember AJ, Phillips C, Borazjani A, Morrison JL, O'Brien LM. Modifying Maternal Sleep Position in Late Pregnancy Through Positional Therapy: A Feasibility Study. J Clin Sleep Med. 2018 Aug 15;14(8):1387-1397. doi: 10.5664/jcsm.7280.
McCowan LME, Thompson JMD, Cronin RS, Li M, Stacey T, Stone PR, Lawton BA, Ekeroma AJ, Mitchell EA. Going to sleep in the supine position is a modifiable risk factor for late pregnancy stillbirth; Findings from the New Zealand multicentre stillbirth case-control study. PLoS One. 2017 Jun 13;12(6):e0179396. doi: 10.1371/journal.pone.0179396. eCollection 2017.
Gordon A, Raynes-Greenow C, Bond D, Morris J, Rawlinson W, Jeffery H. Sleep position, fetal growth restriction, and late-pregnancy stillbirth: the Sydney stillbirth study. Obstet Gynecol. 2015 Feb;125(2):347-355. doi: 10.1097/AOG.0000000000000627.
Platts J, Mitchell EA, Stacey T, Martin BL, Roberts D, McCowan L, Heazell AE. The Midland and North of England Stillbirth Study (MiNESS). BMC Pregnancy Childbirth. 2014 May 21;14:171. doi: 10.1186/1471-2393-14-171.
Warland J, Mitchell EA. A triple risk model for unexplained late stillbirth. BMC Pregnancy Childbirth. 2014 Apr 14;14:142. doi: 10.1186/1471-2393-14-142.
O'Brien LM, Warland J. Typical sleep positions in pregnant women. Early Hum Dev. 2014 Jun;90(6):315-7. doi: 10.1016/j.earlhumdev.2014.03.001. Epub 2014 Mar 21.
Owusu JT, Anderson FJ, Coleman J, Oppong S, Seffah JD, Aikins A, O'Brien LM. Association of maternal sleep practices with pre-eclampsia, low birth weight, and stillbirth among Ghanaian women. Int J Gynaecol Obstet. 2013 Jun;121(3):261-5. doi: 10.1016/j.ijgo.2013.01.013. Epub 2013 Mar 15.
Stacey T, Thompson JM, Mitchell EA, Ekeroma AJ, Zuccollo JM, McCowan LM. Association between maternal sleep practices and risk of late stillbirth: a case-control study. BMJ. 2011 Jun 14;342:d3403. doi: 10.1136/bmj.d3403.
Public notes

Contacts
Principal investigator
Name 0 0
Jane Warland, PhD
Address 0 0
University of South Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04437407