UniSA BackOff! Study: Adelaide PrenaBelt Trial

NCT04437407 | Terminated

• 1 other identifier: 202902
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Stillbirth; Infant, Low Birth Weight; Infant, Very Low Birth Weight; Sleep-Disordered Breathing; Infant, Small for Gestational Age; Fetal Hypoxia; Pregnancy Complications; Fetal Growth Retardation

Keywords

Pregnancy; Sleep; Maternal

Outcome Measures

Primary Outcomes (48)

• Sensitivity of Ajuvia for supine position

  The sensitivity(%) of the Ajuvia in determining the pelvic supine position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  1 night (approximately 8 hours)

• Specificity of Ajuvia for supine position

  The specificity(%) of the Ajuvia in determining the pelvic supine position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  1 night (approximately 8 hours)

• Sensitivity of Ajuvia for prone position

  The sensitivity(%) of the Ajuvia in determining the pelvic prone position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  1 night (approximately 8 hours)

• Specificity of Ajuvia for prone position

  The specificity(%) of the Ajuvia in determining the pelvic prone position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  1 night (approximately 8 hours)

• Sensitivity of Ajuvia for left tilt position

  The sensitivity(%) of the Ajuvia in determining the left pelvic tilt position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  1 night (approximately 8 hours)

• Specificity of Ajuvia for left tilt position

  The specificity(%) of the Ajuvia in determining the left pelvic tilt position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  1 night (approximately 8 hours)

• Sensitivity of Ajuvia for left lateral position

  The sensitivity(%) of the Ajuvia in determining the left lateral pelvic position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  1 night (approximately 8 hours)

• Specificity of Ajuvia for left lateral position

  The specificity(%) of the Ajuvia in determining the left lateral pelvic position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  1 night (approximately 8 hours)

• Sensitivity of Ajuvia for right tilt position

  The sensitivity(%) of the Ajuvia in determining the right pelvic tilt position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  1 night (approximately 8 hours)

• Specificity of Ajuvia for right tilt position

  The specificity(%) of the Ajuvia in determining the right pelvic tilt position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  1 night (approximately 8 hours)

• Sensitivity of Ajuvia for right lateral position

  The sensitivity(%) of the Ajuvia in determining the right lateral pelvic position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  1 night (approximately 8 hours)

• Specificity of Ajuvia for right lateral position

  The specificity(%) of the Ajuvia in determining the right lateral pelvic position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  1 night (approximately 8 hours)

• Supine Sleep Time - Control

  The time (in minutes) spent sleeping in the supine position with Ajuvia in passive mode

  1 night (approximately 8 hours)

• Supine Sleep Time - PB2-1

  The time (in minutes) spent sleeping in the supine position with PB2-1 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Supine Sleep Time - PB2-2

  The time (in minutes) spent sleeping in the supine position with PB2-2 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Supine Sleep Time - PB2-3

  The time (in minutes) spent sleeping in the supine position with PB2-3 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Supine Sleep Time - PB2-4

  The time (in minutes) spent sleeping in the supine position with PB2-4 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Supine Sleep Time - PB2-5

  The time (in minutes) spent sleeping in the supine position with PB2-5 and Ajuvia in active mode

  1 night (approximately 8 hours)

• Prone Sleep Time - Control

  The time (in minutes) spent sleeping in the prone position with Ajuvia in passive mode

  1 night (approximately 8 hours)

• Prone Sleep Time - PB2-1

  The time (in minutes) spent sleeping in the prone position with PB2-1 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Prone Sleep Time - PB2-2

  The time (in minutes) spent sleeping in the prone position with PB2-2 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Prone Sleep Time - PB2-3

  The time (in minutes) spent sleeping in the prone position with PB2-3 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Prone Sleep Time - PB2-4

  The time (in minutes) spent sleeping in the prone position with PB2-4 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Prone Sleep Time - PB2-5

  The time (in minutes) spent sleeping in the prone position with PB2-5 and Ajuvia in active mode

  1 night (approximately 8 hours)

• Left-tilt Sleep Time - Control

  The time (in minutes) spent sleeping in the left pelvic tilt position with Ajuvia in passive mode

  1 night (approximately 8 hours)

• Left-tilt Sleep Time - PB2-1

  The time (in minutes) spent sleeping in the left pelvic tilt position with PB2-1 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Left-tilt Sleep Time - PB2-2

  The time (in minutes) spent sleeping in the left pelvic tilt position with PB2-2 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Left-tilt Sleep Time - PB2-3

  The time (in minutes) spent sleeping in the left pelvic tilt position with PB2-3 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Left-tilt Sleep Time - PB2-4

  The time (in minutes) spent sleeping in the left pelvic tilt position with PB2-4 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Left-tilt Sleep Time - PB2-5

  The time (in minutes) spent sleeping in the left pelvic tilt position with PB2-5 and Ajuvia in active mode

  1 night (approximately 8 hours)

• Left-lateral Sleep Time - Control

  The time (in minutes) spent sleeping in the left lateral position with Ajuvia in passive mode

  1 night (approximately 8 hours)

• Left-lateral Sleep Time - PB2-1

  The time (in minutes) spent sleeping in the left lateral position with PB2-1 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Left-lateral Sleep Time - PB2-2

  The time (in minutes) spent sleeping in the left lateral position with PB2-2 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Left-lateral Sleep Time - PB2-3

  The time (in minutes) spent sleeping in the left lateral position with PB2-3 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Left-lateral Sleep Time - PB2-4

  The time (in minutes) spent sleeping in the left lateral position with PB2-4 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Left-lateral Sleep Time - PB2-5

  The time (in minutes) spent sleeping in the left-lateral position with PB2-5 and Ajuvia in active mode

  1 night (approximately 8 hours)

• Right-tilt Sleep Time - Control

  The time (in minutes) spent sleeping in the right pelvic tilt position with Ajuvia in passive mode

  1 night (approximately 8 hours)

• Right-tilt Sleep Time - PB2-1

  The time (in minutes) spent sleeping in the right pelvic tilt position with PB2-1 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Right-tilt Sleep Time - PB2-2

  The time (in minutes) spent sleeping in the right pelvic tilt position with PB2-2 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Right-tilt Sleep Time - PB2-3

  The time (in minutes) spent sleeping in the right pelvic tilt position with PB2-3 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Right-tilt Sleep Time - PB2-4

  The time (in minutes) spent sleeping in the right pelvic tilt position with PB2-4 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Right-tilt Sleep Time - PB2-5

  The time (in minutes) spent sleeping in the right pelvic tilt position with PB2-5 and Ajuvia in active mode

  1 night (approximately 8 hours)

• Right-lateral Sleep Time - Control

  The time (in minutes) spent sleeping in the right lateral position with Ajuvia in passive mode

  1 night (approximately 8 hours)

• Right-lateral Sleep Time - PB2-1

  The time (in minutes) spent sleeping in the right lateral position with PB2-1 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Right-lateral Sleep Time - PB2-2

  The time (in minutes) spent sleeping in the right lateral position with PB2-2 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Right-lateral Sleep Time - PB2-3

  The time (in minutes) spent sleeping in the right lateral position with PB2-3 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Right-lateral Sleep Time - PB2-4

  The time (in minutes) spent sleeping in the right lateral position with PB2-4 and Ajuvia in passive mode

  1 night (approximately 8 hours)

• Right-lateral Sleep Time - PB2-5

  The time (in minutes) spent sleeping in the right lateral position with PB2-5 and Ajuvia in active mode

  1 night (approximately 8 hours)

Study Arms (6)

Control

OTHER

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.

Device: Ajuvia-Passive

PB2-1

EXPERIMENTAL

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

Device: PB2-1 prototype; Device: Ajuvia-Passive

PB2-2

EXPERIMENTAL

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

Device: PB2-2 prototype; Device: Ajuvia-Passive

PB2-3

EXPERIMENTAL

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

Device: PB2-3 prototype; Device: Ajuvia-Passive

PB2-4

EXPERIMENTAL

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

Device: PB2-4 prototype; Device: Ajuvia-Passive

PB2-5

EXPERIMENTAL

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

Device: PB2-5 prototype; Device: Ajuvia-Active

Interventions

PB2-1 prototype DEVICE

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.

PB2-1

PB2-2 prototype DEVICE

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.

PB2-2

PB2-3 prototype DEVICE

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.

PB2-3

PB2-4 prototype DEVICE

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.

PB2-4

PB2-5 prototype DEVICE

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.

PB2-5

Ajuvia-Active DEVICE

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.

PB2-5

Ajuvia-Passive DEVICE

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.

Control; PB2-1; PB2-2; PB2-3; PB2-4

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• musculoskeletal disorder that prevents sleeping supine or on a certain side (e.g., arthritic shoulder)
• non-English speaking and reading

Sponsors & Collaborators

• Shiphrah Biomedical Inc.: lead
• University of South Australia: collaborator

Study Sites (1)

UniSA Clinical & Health Sciences

Adelaide, South Australia, 5000, Australia

Location

Related Publications (14)

• 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.

  PMID: 30158217 BACKGROUND

• 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.

  PMID: 31048420 BACKGROUND

• 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.

  PMID: 31193832 BACKGROUND

• 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.

  PMID: 30656734 BACKGROUND

• 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.

  PMID: 31577362 BACKGROUND

• 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.

  PMID: 29910107 BACKGROUND

• 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.

  PMID: 30092890 BACKGROUND

• 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.

  PMID: 28609468 BACKGROUND

• 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.

  PMID: 25568999 BACKGROUND

• 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.

  PMID: 24885461 BACKGROUND

• 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.

  PMID: 24731396 BACKGROUND

• 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.

  PMID: 24661447 BACKGROUND

• 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.

  PMID: 23507553 BACKGROUND

• 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.

  PMID: 21673002 BACKGROUND

MeSH Terms

Conditions

Stillbirth; Sleep Apnea Syndromes; Fetal Hypoxia; Pregnancy Complications; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Death; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Growth Disorders

Study Officials

• Jane Warland, PhD

  University of South Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A consecutive, six-night, in-home, controlled, cross-over sleep study in third-trimester pregnant women to validate the ability of the PB2 and Ajuvia devices to reduce the amount of time pregnant women spend sleeping on their backs at night in the home setting in the third trimester of pregnancy

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: February 1, 2020
• Primary Completion: June 10, 2021
• Study Completion: June 15, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)