UniSA BackOff! Study: Adelaide PrenaBelt Trial

Pregnancy Complications Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04437407
• Other study ID #: 202902
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: June 15, 2021

Study information

• Verified date: August 2021
• Source: Shiphrah Biomedical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 15, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

• musculoskeletal disorder that prevents sleeping supine or on a certain side (e.g., arthritic shoulder)

• non-English speaking and reading

Related Conditions & MeSH terms

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

Intervention

Device:
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Australia	UniSA Clinical & Health Sciences	Adelaide	South Australia

Sponsors (2)

Lead Sponsor	Collaborator
Shiphrah Biomedical Inc.	University of South Australia

Country where clinical trial is conducted

Australia, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Supine Sleep Time - Control	The time (in minutes) spent sleeping in the supine position with Ajuvia in passive mode	1 night (approximately 8 hours)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Prone Sleep Time - Control	The time (in minutes) spent sleeping in the prone position with Ajuvia in passive mode	1 night (approximately 8 hours)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)