StillbirthNCT04437407
UniSA BackOff! Study: Adelaide PrenaBelt Trial
A study testing PB2-1 prototype, PB2-2 prototype and PB2-3 prototype in people with Stillbirth and Infant, Low Birth Weight, run by Shiphrah Biomedical Inc. at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stillbirth, Infant, Low Birth Weight, Infant, Very Low Birth Weight
- What is being tested?
- PB2-1 prototype, PB2-2 prototype and PB2-3 prototype
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Feb 2020to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- musculoskeletal disorder that prevents sleeping supine or on a certain side (e.g., arthritic shoulder)
- non-English speaking and reading
Trial locations and contacts
1 site in 1 country.
Australia1 site
UniSA Clinical & Health Sciences
Adelaide, South Australia, 5000
About this study
Official 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
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.
Read more
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.
Read the detailed description
The ability of the PB2 prototypes 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 will be evaluated via a consecutive, six-night, in-home, controlled, cross-over sleep study in third trimester pregnant women where the Ajuvia Sleep Monitor is validated against infrared video on the first night.
Six nights: the first night is a control night with infrared video recording where only the Ajuvia is worn in passive mode to collect data on the participant's body position and is followed by five nights with the five different prototypes.
Randomization: The order in which the different devices will be worn on the second night through fourth night, inclusive, will be determined by simple randomization. This will minimize the potential impact of changes to sleep across the nights resulting from familiarization with the equipment as the sleep tests proceed through the five non-control nights, which could bias the results. For logistical reasons, the sixth night is non-randomized and will include the Ajuvia in 'active' mode Cross-over: After the first night, on each of the subsequent four nights, the participants will "cross over" to a different PB2 device (depending on their randomization order) and "cross over" to the Ajuvia in 'active' mode on the sixth night to allow each participant to act as her own control for comparison of treatment effect on outcomes.
In home: conducting this study in the home setting will allow for a more accurate representation of sleep patterns as the participants will be in the comfort of their own bed.
Sleep test: The maternal pelvis position will be recorded while the participants are sleeping using the Ajuvia device. Going to bed- and wake-times, as well as experience with each device will be recorded daily in a sleep diary.
- Conditions
- Stillbirth, Infant, Low Birth Weight, Infant, Very Low Birth Weight, Sleep-Disordered Breathing, Infant, Small for Gestational Age, Fetal Hypoxia
- Being tested
- PB2-1 prototype, PB2-2 prototype, PB2-3 prototype, PB2-4 prototype, PB2-5 prototype
- Keywords
- Pregnancy, Sleep, Maternal
- Medical subject headings
- Stillbirth, Sleep Apnea Syndromes, Fetal Hypoxia, Pregnancy Complications, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PB2-1 prototypeDevice
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.
PB2-2 prototypeDevice
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.
PB2-3 prototypeDevice
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.
PB2-4 prototypeDevice
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.
PB2-5 prototypeDevice
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.
Ajuvia-ActiveDevice
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.
Ajuvia-PassiveDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ajuvia-Passive |
| PB2-1 | Experimental | During this night, the PB2-1 prototype will be worn with the Ajuvia in passive mode. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: PB2-5 prototype; Device: Ajuvia-Active |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 night (approximately 8 hours)
Supine Sleep Time - Control
The time (in minutes) spent sleeping in the supine position with Ajuvia in passive mode
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 night (approximately 8 hours)
Prone Sleep Time - Control
The time (in minutes) spent sleeping in the prone position with Ajuvia in passive mode
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 night (approximately 8 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start1 Feb 2020
- Primary completion10 Jun 2021
- Study completion15 Jun 2021
Why it stopped: Participant dropout and technical difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for StillbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiphrah Biomedical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of South Australia
- Responsible party
- Sponsor
- Investigators
- Jane Warland, PhD, Principal investigator, University of South Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437407
- Sponsor's protocol ID
- 202902
- Status last verified
- Aug 2021
- First submitted
- 16 Jun 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30158217Coleman 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.
PubMed 31048420Cronin 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.
PubMed 31193832O'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.
PubMed 30656734Anderson 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.
PubMed 31577362Warland 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.
PubMed 29910107Warland 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.
PubMed 30092890McCowan 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.
PubMed 28609468Gordon 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.
PubMed 25568999Platts 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.
PubMed 24885461Warland 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.
PubMed 24731396O'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.
PubMed 24661447Owusu 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.
PubMed 23507553Stacey 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.
PubMed 21673002
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04437407
- Acronym / sponsor ID
- 202902
- Conditions
- Stillbirth, Infant, Low Birth Weight, Infant, Very Low Birth Weight, Sleep-Disordered Breathing, Infant, Small for Gestational Age, Fetal Hypoxia
- Keywords
- Pregnancy, Sleep, Maternal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participant dropout and technical difficulties
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Shiphrah Biomedical Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of South Australia
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The ability of the PB2 prototypes 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 will be evaluated via a consecutive, six-night, in-home, controlled, cross-over sleep study in third trimester pregnant women where the Ajuvia Sleep Monitor is validated against infrared video on the first night.
Six nights: the first night is a control night with infrared video recording where only the Ajuvia is worn in passive mode to collect data on the participant's body position and is followed by five nights with the five different prototypes.
Randomization: The order in which the different devices will be worn on the second night through fourth night, inclusive, will be determined by simple randomization. This will minimize the potential impact of changes to sleep across the nights resulting from familiarization with the equipment as the sleep tests proceed through the five non-control nights, which could bias the results. For logistical reasons, the sixth night is non-randomized and will include the Ajuvia in 'active' mode Cross-over: After the first night, on each of the subsequent four nights, the participants will "cross over" to a different PB2 device (depending on their randomization order) and "cross over" to the Ajuvia in 'active' mode on the sixth night to allow each participant to act as her own control for comparison of treatment effect on outcomes.
In home: conducting this study in the home setting will allow for a more accurate representation of sleep patterns as the participants will be in the comfort of their own bed.
Sleep test: The maternal pelvis position will be recorded while the participants are sleeping using the Ajuvia device. Going to bed- and wake-times, as well as experience with each device will be recorded daily in a sleep diary.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Device: Ajuvia-PassiveThe 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. |
| PB2-1 | Experimental | Device: PB2-1 prototype, Device: Ajuvia-PassiveDuring this night, the PB2-1 prototype will be worn with the Ajuvia in passive mode. |
| PB2-2 | Experimental | Device: PB2-2 prototype, Device: Ajuvia-PassiveDuring this night, the PB2-2 prototype will be worn with the Ajuvia in passive mode. |
| PB2-3 | Experimental | Device: PB2-3 prototype, Device: Ajuvia-PassiveDuring this night, the PB2-3 prototype will be worn with the Ajuvia in passive mode. |
| PB2-4 | Experimental | Device: PB2-4 prototype, Device: Ajuvia-PassiveDuring this night, the PB2-4 prototype will be worn with the Ajuvia in passive mode. |
| PB2-5 | Experimental | Device: PB2-5 prototype, Device: Ajuvia-ActiveDuring this night, the PB2-5 prototype will be worn with the Ajuvia in active mode. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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.
Key exclusion criteria (2 listed)
- musculoskeletal disorder that prevents sleeping supine or on a certain side (e.g., arthritic shoulder)
- non-English speaking and reading
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PB2-1 prototypePB2-1 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. | Device | PB2-1 |
| PB2-2 prototypePB2-2 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. | Device | PB2-2 |
| PB2-3 prototypePB2-3 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. | Device | PB2-3 |
| PB2-4 prototypePB2-4 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. | Device | PB2-4 |
| PB2-5 prototypePB2-5 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. | Device | PB2-5 |
| Ajuvia-ActiveAjuvia 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. | Device | PB2-5 |
| Ajuvia-PassiveAjuvia 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. | Device | Control, PB2-1, PB2-2, PB2-3, PB2-4 |
Primary outcome
Sensitivity of Ajuvia for supine position
Time frame: 1 night (approximately 8 hours)
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.
Specificity of Ajuvia for supine position
Time frame: 1 night (approximately 8 hours)
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.
Sensitivity of Ajuvia for prone position
Time frame: 1 night (approximately 8 hours)
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.
Specificity of Ajuvia for prone position
Time frame: 1 night (approximately 8 hours)
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.
Sensitivity of Ajuvia for left tilt position
Time frame: 1 night (approximately 8 hours)
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.
Specificity of Ajuvia for left tilt position
Time frame: 1 night (approximately 8 hours)
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.
Sensitivity of Ajuvia for left lateral position
Time frame: 1 night (approximately 8 hours)
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.
Specificity of Ajuvia for left lateral position
Time frame: 1 night (approximately 8 hours)
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.
Sensitivity of Ajuvia for right tilt position
Time frame: 1 night (approximately 8 hours)
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.
Specificity of Ajuvia for right tilt position
Time frame: 1 night (approximately 8 hours)
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.
Sensitivity of Ajuvia for right lateral position
Time frame: 1 night (approximately 8 hours)
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.
Specificity of Ajuvia for right lateral position
Time frame: 1 night (approximately 8 hours)
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.
Supine Sleep Time - Control
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the supine position with Ajuvia in passive mode
Supine Sleep Time - PB2-1
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the supine position with PB2-1 and Ajuvia in passive mode
Supine Sleep Time - PB2-2
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the supine position with PB2-2 and Ajuvia in passive mode
Supine Sleep Time - PB2-3
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the supine position with PB2-3 and Ajuvia in passive mode
Supine Sleep Time - PB2-4
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the supine position with PB2-4 and Ajuvia in passive mode
Supine Sleep Time - PB2-5
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the supine position with PB2-5 and Ajuvia in active mode
Prone Sleep Time - Control
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the prone position with Ajuvia in passive mode
Prone Sleep Time - PB2-1
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the prone position with PB2-1 and Ajuvia in passive mode
Prone Sleep Time - PB2-2
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the prone position with PB2-2 and Ajuvia in passive mode
Prone Sleep Time - PB2-3
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the prone position with PB2-3 and Ajuvia in passive mode
Prone Sleep Time - PB2-4
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the prone position with PB2-4 and Ajuvia in passive mode
Prone Sleep Time - PB2-5
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the prone position with PB2-5 and Ajuvia in active mode
Left-tilt Sleep Time - Control
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the left pelvic tilt position with Ajuvia in passive mode
Left-tilt Sleep Time - PB2-1
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the left pelvic tilt position with PB2-1 and Ajuvia in passive mode
Left-tilt Sleep Time - PB2-2
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the left pelvic tilt position with PB2-2 and Ajuvia in passive mode
Left-tilt Sleep Time - PB2-3
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the left pelvic tilt position with PB2-3 and Ajuvia in passive mode
Left-tilt Sleep Time - PB2-4
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the left pelvic tilt position with PB2-4 and Ajuvia in passive mode
Left-tilt Sleep Time - PB2-5
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the left pelvic tilt position with PB2-5 and Ajuvia in active mode
Left-lateral Sleep Time - Control
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the left lateral position with Ajuvia in passive mode
Left-lateral Sleep Time - PB2-1
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the left lateral position with PB2-1 and Ajuvia in passive mode
Left-lateral Sleep Time - PB2-2
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the left lateral position with PB2-2 and Ajuvia in passive mode
Left-lateral Sleep Time - PB2-3
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the left lateral position with PB2-3 and Ajuvia in passive mode
Left-lateral Sleep Time - PB2-4
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the left lateral position with PB2-4 and Ajuvia in passive mode
Left-lateral Sleep Time - PB2-5
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the left-lateral position with PB2-5 and Ajuvia in active mode
Right-tilt Sleep Time - Control
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the right pelvic tilt position with Ajuvia in passive mode
Right-tilt Sleep Time - PB2-1
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the right pelvic tilt position with PB2-1 and Ajuvia in passive mode
Right-tilt Sleep Time - PB2-2
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the right pelvic tilt position with PB2-2 and Ajuvia in passive mode
Right-tilt Sleep Time - PB2-3
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the right pelvic tilt position with PB2-3 and Ajuvia in passive mode
Right-tilt Sleep Time - PB2-4
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the right pelvic tilt position with PB2-4 and Ajuvia in passive mode
Right-tilt Sleep Time - PB2-5
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the right pelvic tilt position with PB2-5 and Ajuvia in active mode
Right-lateral Sleep Time - Control
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the right lateral position with Ajuvia in passive mode
Right-lateral Sleep Time - PB2-1
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the right lateral position with PB2-1 and Ajuvia in passive mode
Right-lateral Sleep Time - PB2-2
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the right lateral position with PB2-2 and Ajuvia in passive mode
Right-lateral Sleep Time - PB2-3
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the right lateral position with PB2-3 and Ajuvia in passive mode
Right-lateral Sleep Time - PB2-4
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the right lateral position with PB2-4 and Ajuvia in passive mode
Right-lateral Sleep Time - PB2-5
Time frame: 1 night (approximately 8 hours)
The time (in minutes) spent sleeping in the right lateral position with PB2-5 and Ajuvia in active mode
Results and safety
The study was stopped early (reason given: Participant dropout and technical difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Background: PubMed 30158217Kember 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.
- Background: PubMed 31048420Coleman 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.
- Background: PubMed 31193832Cronin 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.
- Background: PubMed 30656734O'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.
- Background: PubMed 31577362Anderson 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.
- Background: PubMed 29910107Warland 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.
- Background: PubMed 30092890Warland 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.
- Background: PubMed 28609468McCowan 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.
- Background: PubMed 25568999Gordon 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.
- Background: PubMed 24885461Platts 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.
- Background: PubMed 24731396Warland 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.
- Background: PubMed 24661447O'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.
- Individual participant dataSharing planned: No
Related trials for Stillbirth
Not yet recruiting
e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss
Depressive Symptoms, Perinatal Loss
RecruitingObservational study
Advancing Stillbirth Prevention Through Innovative Risk Evaluation (ASPIRE) Clinical Study
GDM, Preterm Preeclampsia
Not yet recruiting
Improving Maternal and Neonatal Care-seeking Through a Video-informed Training Session During the Third Trimester of Pregnancy
Maternal Health, Neonatal Health
RecruitingObservational study
Feasibility Trial of the Womb Watch Smartphone App To Assess Fetal Movements
Assessment of Fetal Movement, Pregnancy
RecruitingPhase 4
Comparison of High- Versus Low-Dose Aspirin for Pregnancy Outcomes in Women at High Risk of Preeclampsia
Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Warland, PhD principal investigator
University of South Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PB2-1 prototype, PB2-2 prototype and PB2-3 prototype in people with Stillbirth and Infant, Low Birth Weight, run by Shiphrah Biomedical Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Participant dropout and technical difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Ajuvia for supine position (time frame: 1 night (approximately 8 hours)). The study lists 48 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04437407, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.