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| Name | Class |
|---|---|
| Grand Challenges Canada | OTHER |
| Innovative Canadians for Change | OTHER |
| Global Innovations for Reproductive Health and Life | OTHER |
| Kaishin Chu Design |
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Back and right-sided sleeping position in pregnant women has recently emerged as a potential risk factor for low birthweight (LBW) and stillbirth (SB) in the medical literature. Assuming that sleep position in pregnant women is modifiable, the same literature has indicated that this risk factor is modifiable; however, there is no evidence that this risk factor is truly modifiable.
The proposed link between back and right-sided sleeping position in a pregnant woman and LBW and SB of her baby is multifactorial; however, it ultimately implicates the woman's body position in causing compression of one of the large veins that brings blood back to her heart. This compression, along with other factors relating to the woman, her placenta, and her developing fetus, may result in decreased blood flow (nutrition and oxygen) to her developing baby, which, depending on the extent and duration, could result in LBW or SB of her baby. If the back sleeping position during pregnancy has a causative role in LBW and subsequently SB, the literature indicates that up to 17% of LBW and consequently 26% of SB could potentially be prevented by changing position to avoid back sleep. Note that 20 million LBW and 2.6 million SB occur each year worldwide.
Positional therapy (PT) is a safe and effective intervention for preventing people who snore or people who's breathing pauses during sleep from sleeping on their back - a position that makes their condition worse. The most basic form of PT modifies a person's sleeping position by either:
The purpose of this study is to evaluate the ability of a PT intervention to modify the position of pregnant women from their back and right side to their left side while they sleep in late pregnancy.
This study will help determine whether this potential risk factor is modifiable by way of a PT intervention, and whether it is feasible to intervene to reduce or prevent back and right-sided position sleep in late pregnancy. Demonstrating that the sleeping position of pregnant women can be modified through use of a simple, inexpensive PT intervention may be one of the keys to achieving significant reductions in LBW and late SB rates in Canada and worldwide.
The utility of the PrenaBelt in modifying maternal sleeping position and the effect of the PrenaBelt on maternal respiratory and cardiovascular parameters during sleep and sleep staging in the third trimester of pregnancy will be evaluated via a two-night, randomized, cross-over, sham-controlled, triple-blind, sleep study in third trimester pregnant women.
Two nights: one night with a positional therapy (PT) device and one night with sham-PT device to determine treatment effect on outcomes.
Randomized: participants will be randomized to treatment order: sham-PT on first night, then PT on second night, or vice versa. This will avoid the potential impact of changes to sleep across the two nights resulting from familiarization with the equipment, which could bias the results.
Cross-over: on the second night, each participant will be crossed over from PT to sham-PT (or vice versa, depending on randomization order) to allow each participant to act as her own control for comparison of treatment effect on outcomes.
Sham-controlled: a sham-PT device that has the same fit and form of the PT device but without the ability of function (pressure points) will be used as a control. The purpose of a sham-PT device is to identify any specific benefit of one element of a PT device (e.g., fit or form) above and beyond all benefits that might be attributed to everything else about that device (e.g., function). Note that there is no established effective therapy for the population for the indication under study.
Triple blind: participants, sleep technologists monitoring and scoring the sleep tests, and the specialized sleep physician reviewing and reporting the sleep test results will be blinded to the intervention received each night.
Laboratory: conducting this study in a controlled lab setting will allow for continual, real time monitoring of various cardiovascular, respiratory, and sleep parameters of each participant by the sleep technologist. This contributes to a more controlled and safer study overall.
Sleep test: body position, various cardiovascular and respiratory parameters, and sleep parameters will be continuously recorded while the participants are sleeping. Sleep lab procedures will be followed by the personnel conducting, scoring, reviewing, and reporting the sleep tests from participant preparation through discharge
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PrenaBelt on First Sleep Test Night | Experimental | Participants will be randomized to treatment order: sham PrenaBelt on first night, then PrenaBelt on second night, or vice versa. This will avoid the potential impact of changes to sleep across the two nights resulting from familiarization with the polysomnography equipment, which could bias the results. |
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| Sham PrenaBelt on First Sleep Test Night | Sham Comparator | Participants will be randomized to treatment order: sham PrenaBelt on first night, then PrenaBelt on second night, or vice versa. This will avoid the potential impact of changes to sleep across the two nights resulting from familiarization with the polysomnography equipment, which could bias the results. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrenaBelt | Device | The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT. PT is a simple, non-invasive, inexpensive, long-established, safe, and effective intervention for preventing people with positional-dependent snoring or obstructive sleep apnea from sleeping on their back - a position that exacerbates their condition. The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back and right side of the user when she lies on her back or right side, respectively, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back or right side. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage (%) of Sleep Time Supine | Proportion of sleeping time spent in the supine position | 1 night (approximately 8 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Total Sleep Time | This is a standard polysomnography measure of the amount of time the participant spent sleeping during the sleep test. | 1 night (approximately 8 hours) |
| Supine Sleep Time | The time (in minutes) spent sleeping in the supine position. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather Scott, MD FRCSC | The IWK Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IWK Women's Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23507553 | 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. | |
| 21673002 | Background |
| Label | URL |
|---|---|
| Allan Kember's (Project Lead, Project Principal Investigator) blog - Project Updates | View source |
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There was no run-in measurement of baseline sleep habits. The study nights were not required to be consecutive dates. We did not specify a defined washout period. 28 participants were assessed for eligibility. Following exclusion of three who declined participation and two who failed to meet eligibility criteria, 23 were randomized.
Participants were recruited from April 4 2016 through January 27 2017.
Participants were recruited by a trained nurse a prenatal clinic at the Izaak Walton Killam (IWK) Health Centre, Halifax, Canada, which is a tertiary and primary care center for women and children.
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| ID | Title | Description |
|---|---|---|
| FG000 | PrenaBelt on First Night, Sham PrenaBelt on Second Night | These participants were randomized to receive the PrenaBelt on first night, and the sham-PrenaBelt on second night. PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT. The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back. Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points. |
| FG001 | Sham PrenaBelt on First Night, PrenaBelt on Second Night | These participants were randomized to receive the sham-PrenaBelt on first night, and the PrenaBelt on second night. PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT. The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back. Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Of 23 participants randomized, 3 discontinued participation in the study after the first night, and 20 (10 in each group) completed the study. Baseline demographic, obstetric, and sleep habit characteristics of the 20 participants who completed the study are shown per randomized group (n=10 each).
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| ID | Title | Description |
|---|---|---|
| BG000 | PrenaBelt on First Night, Sham PrenaBelt on Second Night | These participants were randomized to receive the PrenaBelt on first night, and the sham-PrenaBelt on second night. PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT. The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back. Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage (%) of Sleep Time Supine | Proportion of sleeping time spent in the supine position | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Median | Inter-Quartile Range | percentage of sleep time (%) | 1 night (approximately 8 hours) |
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Participants completed their polysomnography studies from April 8 2016 through January 27 2017. Each participant that finished the study completed two full nights (7pm to 7am) in the polysomnography laboratory.
Participants were permitted to remove the intervention and/or polysomnography (PSG) equipment at any point if they became uncomfortable. No participants (including the three who did not complete the study) requested to remove the intervention or PSG equipment. There were no known harms related to the interventions or procedures in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PrenaBelt on First Night, Sham PrenaBelt on Second Night | These participants were randomized to receive the PrenaBelt on first night, and the sham-PrenaBelt on second night. PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT. The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back. Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points. |
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Performed in a controlled sleep laboratory setting over two nights; therefore, caution should be taken when extrapolating the results to the home setting and across the third trimester. Due to the small sample, may have been under-powered.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Allan Kember, Director of Programs | Global Innovations for Reproductive Health & Life | +1-902-580-8385 | allan.kember@mail.utoronto.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 26, 2015 | Jun 7, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 15, 2016 | Jun 7, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D050497 | Stillbirth |
| D005317 | Fetal Growth Retardation |
| D005311 | Fetal Hypoxia |
| D008192 | Deception |
| ID | Term |
|---|---|
| D005313 | Fetal Death |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| INDUSTRY |
| Nova Scotia Health Authority | OTHER |
| University of Michigan | OTHER |
| Harvard University | OTHER |
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|
| Sham PrenaBelt | Device | The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points. |
|
| 1 night (approximately 8 hours) |
| Left-lateral Sleep Time | Time (in minutes) spent sleeping in the left-lateral position. | 1 night (approximately 8 hours) |
| Right-lateral Sleep Time | Time (in minutes) spent sleeping in the right-lateral position. | 1 night (approximately 8 hours) |
| Percentage Sleep Left | Percentage (%) of sleeping time in the left-lateral position. | 1 night (approximately 8 hours) |
| Percentage Sleep Right | Percentage (%) of sleeping time in the right-lateral position. | 1 night (approximately 8 hours) |
| Sleep Latency | This is a standard polysomnography measure of the amount of time (in minutes) that it takes a participant to transition from full wakefulness to sleep. | 1 night (approximately 8 hours) |
| Sleep Efficiency | This is a standard polysomnography measure of the percentage (%) of time the participant was asleep during the sleep test. | 1 night (approximately 8 hours) |
| Total Arousal Index | This is a standard polysomnography measure of the number of times the participant was aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness. This is reported as a 'total arousal index', which is an average of the number of arousals per hour, and is further classified as a spontaneous, periodic leg movement, or respiratory arousal index. | 1 night (approximately 8 hours) |
| Spontaneous Arousal Index | This is a standard polysomnography measure of the number of times the participant was spontaneously aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness. This is reported as an 'arousal index', which is an average of the number of arousals per hour. | 1 night (approximately 8 hours) |
| Periodic Limb Movement Arousal Index | This is a standard polysomnography measure of the number of times the participant was aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness due to periodic limb movements (PLMs). This is reported as an 'arousal index', which is an average of the number of arousals per hour. | 1 night (approximately 8 hours) |
| Respiratory Arousal Index | This is a standard polysomnography measure of the number of times the participant was aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness due to respiratory events. This is reported as an 'arousal index', which is an average of the number of arousals per hour. | 1 night (approximately 8 hours) |
| Percent Stage 1 Sleep | Percent (%) of total sleep time in sleep stage 1. | 1 night (approximately 8 hours) |
| Percent Stage 2 Sleep | Percent (%) of total sleep time in sleep stage 2. | 1 night (approximately 8 hours) |
| Percent Stage 3 Sleep | Percent (%) of total sleep time in sleep stage 3. | 1 night (approximately 8 hours) |
| Percent REM Sleep | Percent (%) of total sleep time in rapid eye movement (REM) sleep | 1 night (approximately 8 hours) |
| Apnea Hypopnea Index | Apnea hypopnea index (AHI) is a standard polysomnography measure to indicate the severity of sleep apnea. AHI is the average number of apnea and hypopnea events per hour. Will be reported as a total AHI in units of 'events per hour'. | 1 night (approximately 8 hours) |
| Respiratory Effort-Related Arousal Index | Respiratory Effort-Related Arousal (RERA) index is a standard polysomnography measure to indicate arousals from respiratory effort. Will be reported in units of 'arousals per hour'. | 1 night (approximately 8 hours) |
| Respiratory Disturbance Index (RDI) | This is a standard polysomnography measure. Like the AHI, RDI reports on respiratory events during sleep, but unlike the AHI, it also includes respiratory-effort related arousals (RERAs). RERAs are arousals from sleep that do not technically meet the definitions of apneas or hypopneas, but do disrupt sleep. Will be reported as a total RDI as well as RDI while supine and RDI while non-supine. | 1 night (approximately 8 hours) |
| Peripheral Blood Oxygen Saturation (SpO2) | SpO2 measured by fingertip pulse oximetry is a standard measure to indicate the oxygen saturation. Mean SpO2, Min SpO2, and Max SpO2 during Rapid Eye Movement (REM), and Non-REM (NREM) states. | 1 night (approximately 8 hours) |
| Number of Participants With Snoring | This is a standard polysomnography measure of the presence of snoring via nasal cannula (pressure transducer) and by objective report of the research assistant (real-time audio feed). | 1 night (approximately 8 hours) |
| PrenaBelt User Feedback Questionnaire - Satisfaction | Each participant will complete the PrenaBelt User Feedback Questionnaire. On a scale of 1 to 10, participant's level of satisfaction with the PrenaBelt. Note: 1 = extremely dissatisfied 5-6 = acceptable 10 = extremely satisfied | 1 night (approximately 8 hours) |
| PrenaBelt User Feedback Questionnaire - Comfort | Each participant will complete the PrenaBelt User Feedback Questionnaire. On a scale of 1 to 10, participant's level of comfort while wearing and sleeping with the PrenaBelt. Note: 1 = extremely uncomfortable 5-6 = acceptable 10 = extremely comfortable | 1 night (approximately 8 hours) |
| PrenaBelt User Feedback Questionnaire - Intention to Use | Each participant will complete the PrenaBelt User Feedback Questionnaire. On a scale of 1 to 10, participant's intention to use the PrenaBelt during a subsequent pregnancy if it was available to her. Note: 1 = participant would never use it again 5-6 = participant would consider using it again 10 = participant would certainly use it again | 1 night (approximately 8 hours) |
| Sleep Onset Position | To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the sleep onset position (left, supine, right) per the participant's self report and is compared with the sleep onset position (left, supine, right) per the polysomnography data. | 1 night (approximately 8 hours) |
| Waking Position | To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the participant's waking position (left, supine, right, prone) per the participant's self report and is compared with the waking position (left, supine, right, prone) per the polysomnography data. | 1 night (approximately 8 hours) |
| Number of Position Changes | To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the number of times the participant changed body position (e.g., supine to left side) per the participant's self report and is compared with the number of times the participant changed body position per the polysomnography data. | 1 night (approximately 8 hours) |
| Percentage of Total Sleep Time in Each Position | To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the percentage (%) of total sleep time in each position (left, supine, right, prone) per the participant's self report and is compared with the percentage (%) of total sleep time in each position (left, supine, right, prone) per the polysomnography data. | 1 night (approximately 8 hours) |
| 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. |
| 25568999 | 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. |
| 24885461 | 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. |
| 24731396 | 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. |
| 24661447 | 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. |
| 30158217 | Derived | 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. |
| Grand Challenges Canada - News Release | View source |
| Global Innovations for Reproductive Health and Life | View source |
| BG001 | Sham PrenaBelt on First Night, PrenaBelt on Second Night | These participants were randomized to receive the sham-PrenaBelt on first night, and the PrenaBelt on second night. PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT. The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back. Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Pre-pregnancy BMI | Mean | Standard Deviation | kg/m^2 |
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| Current BMI | Mean | Standard Deviation | kg/m^2 |
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| Gestational age | Mean | Standard Deviation | weeks |
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| Gravidity | Count of Participants | Participants |
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| Nightly sleep duration | Median | Inter-Quartile Range | hours |
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| In the last week, sleep onset position | Count of Participants | Participants |
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| In the last week, waking position | Count of Participants | Participants |
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| When not pregnant, sleep onset position | Count of Participants | Participants |
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| When not pregnant, waking position | Count of Participants | Participants |
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| Snores ≥3 nights per week | Count of Participants | Participants |
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| Sleeps with bed partner | Count of Participants | Participants |
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| Pillow use | Count of Participants | Participants |
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| OG001 | Sham PrenaBelt Night | On this night, the participants wore the sham PrenaBelt. Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points. |
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| Secondary | Total Sleep Time | This is a standard polysomnography measure of the amount of time the participant spent sleeping during the sleep test. | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Median | Inter-Quartile Range | minutes | 1 night (approximately 8 hours) |
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| Secondary | Supine Sleep Time | The time (in minutes) spent sleeping in the supine position. | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Median | Inter-Quartile Range | minutes | 1 night (approximately 8 hours) |
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| Secondary | Left-lateral Sleep Time | Time (in minutes) spent sleeping in the left-lateral position. | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Mean | Standard Deviation | minutes | 1 night (approximately 8 hours) |
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| Secondary | Right-lateral Sleep Time | Time (in minutes) spent sleeping in the right-lateral position. | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Mean | Standard Deviation | minutes | 1 night (approximately 8 hours) |
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| Secondary | Percentage Sleep Left | Percentage (%) of sleeping time in the left-lateral position. | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Mean | Standard Deviation | percentage of sleep time (%) | 1 night (approximately 8 hours) |
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| Secondary | Percentage Sleep Right | Percentage (%) of sleeping time in the right-lateral position. | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Mean | Standard Deviation | percentage of sleep time (%) | 1 night (approximately 8 hours) |
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| Secondary | Sleep Latency | This is a standard polysomnography measure of the amount of time (in minutes) that it takes a participant to transition from full wakefulness to sleep. | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Median | Inter-Quartile Range | minutes | 1 night (approximately 8 hours) |
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| Secondary | Sleep Efficiency | This is a standard polysomnography measure of the percentage (%) of time the participant was asleep during the sleep test. | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Median | Inter-Quartile Range | percentage of sleep time (%) | 1 night (approximately 8 hours) |
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| Secondary | Total Arousal Index | This is a standard polysomnography measure of the number of times the participant was aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness. This is reported as a 'total arousal index', which is an average of the number of arousals per hour, and is further classified as a spontaneous, periodic leg movement, or respiratory arousal index. | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Median | Inter-Quartile Range | arousals per hour | 1 night (approximately 8 hours) |
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| Secondary | Spontaneous Arousal Index | This is a standard polysomnography measure of the number of times the participant was spontaneously aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness. This is reported as an 'arousal index', which is an average of the number of arousals per hour. | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Mean | Standard Deviation | arousals per hour | 1 night (approximately 8 hours) |
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| Secondary | Periodic Limb Movement Arousal Index | This is a standard polysomnography measure of the number of times the participant was aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness due to periodic limb movements (PLMs). This is reported as an 'arousal index', which is an average of the number of arousals per hour. | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Median | Inter-Quartile Range | arousals per hour | 1 night (approximately 8 hours) |
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| Secondary | Respiratory Arousal Index | This is a standard polysomnography measure of the number of times the participant was aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness due to respiratory events. This is reported as an 'arousal index', which is an average of the number of arousals per hour. | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Median | Inter-Quartile Range | arousals per hour | 1 night (approximately 8 hours) |
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| Secondary | Percent Stage 1 Sleep | Percent (%) of total sleep time in sleep stage 1. | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Mean | Standard Deviation | percentage of sleep time (%) | 1 night (approximately 8 hours) |
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| Secondary | Percent Stage 2 Sleep | Percent (%) of total sleep time in sleep stage 2. | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Mean | Standard Deviation | percentage of sleep time (%) | 1 night (approximately 8 hours) |
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| Secondary | Percent Stage 3 Sleep | Percent (%) of total sleep time in sleep stage 3. | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Mean | Standard Deviation | percentage of sleep time (%) | 1 night (approximately 8 hours) |
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| Secondary | Percent REM Sleep | Percent (%) of total sleep time in rapid eye movement (REM) sleep | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Mean | Standard Deviation | percentage of sleep time (%) | 1 night (approximately 8 hours) |
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| Secondary | Apnea Hypopnea Index | Apnea hypopnea index (AHI) is a standard polysomnography measure to indicate the severity of sleep apnea. AHI is the average number of apnea and hypopnea events per hour. Will be reported as a total AHI in units of 'events per hour'. | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Median | Inter-Quartile Range | events per hour | 1 night (approximately 8 hours) |
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| Secondary | Respiratory Effort-Related Arousal Index | Respiratory Effort-Related Arousal (RERA) index is a standard polysomnography measure to indicate arousals from respiratory effort. Will be reported in units of 'arousals per hour'. | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Median | Inter-Quartile Range | arousals per hour | 1 night (approximately 8 hours) |
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| Secondary | Respiratory Disturbance Index (RDI) | This is a standard polysomnography measure. Like the AHI, RDI reports on respiratory events during sleep, but unlike the AHI, it also includes respiratory-effort related arousals (RERAs). RERAs are arousals from sleep that do not technically meet the definitions of apneas or hypopneas, but do disrupt sleep. Will be reported as a total RDI as well as RDI while supine and RDI while non-supine. | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Median | Inter-Quartile Range | events per hour | 1 night (approximately 8 hours) |
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| Secondary | Peripheral Blood Oxygen Saturation (SpO2) | SpO2 measured by fingertip pulse oximetry is a standard measure to indicate the oxygen saturation. Mean SpO2, Min SpO2, and Max SpO2 during Rapid Eye Movement (REM), and Non-REM (NREM) states. | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Median | Inter-Quartile Range | percentage of SpO2 (%) | 1 night (approximately 8 hours) |
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| Secondary | Number of Participants With Snoring | This is a standard polysomnography measure of the presence of snoring via nasal cannula (pressure transducer) and by objective report of the research assistant (real-time audio feed). | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Count of Participants | Participants | 1 night (approximately 8 hours) |
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| Secondary | PrenaBelt User Feedback Questionnaire - Satisfaction | Each participant will complete the PrenaBelt User Feedback Questionnaire. On a scale of 1 to 10, participant's level of satisfaction with the PrenaBelt. Note: 1 = extremely dissatisfied 5-6 = acceptable 10 = extremely satisfied | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Median | Inter-Quartile Range | units on a scale | 1 night (approximately 8 hours) |
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| Secondary | PrenaBelt User Feedback Questionnaire - Comfort | Each participant will complete the PrenaBelt User Feedback Questionnaire. On a scale of 1 to 10, participant's level of comfort while wearing and sleeping with the PrenaBelt. Note: 1 = extremely uncomfortable 5-6 = acceptable 10 = extremely comfortable | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Median | Inter-Quartile Range | units on a scale | 1 night (approximately 8 hours) |
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| Secondary | PrenaBelt User Feedback Questionnaire - Intention to Use | Each participant will complete the PrenaBelt User Feedback Questionnaire. On a scale of 1 to 10, participant's intention to use the PrenaBelt during a subsequent pregnancy if it was available to her. Note: 1 = participant would never use it again 5-6 = participant would consider using it again 10 = participant would certainly use it again | Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt). | Posted | Median | Inter-Quartile Range | units on a scale | 1 night (approximately 8 hours) |
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| Secondary | Sleep Onset Position | To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the sleep onset position (left, supine, right) per the participant's self report and is compared with the sleep onset position (left, supine, right) per the polysomnography data. | 20 participants completed the study and each spent 2 nights in the sleep lab (1 night wearing the PrenaBelt and 1 night wearing the sham PrenaBelt), which is 40 nights (40 self-reports and 40 polysomnography reports). The Arms/Groups are combined in this analysis because the treatment order was not expected to affect the accuracy of self-reporting. | Posted | Count of Units | Nights | 1 night (approximately 8 hours) | Nights | Nights |
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| Secondary | Waking Position | To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the participant's waking position (left, supine, right, prone) per the participant's self report and is compared with the waking position (left, supine, right, prone) per the polysomnography data. | 20 participants completed the study and each spent 2 nights in the sleep lab (1 night wearing the PrenaBelt and 1 night wearing the sham PrenaBelt), which is 40 nights (40 self-reports and 40 polysomnography reports). The Arms/Groups are combined in this analysis because the treatment order was not expected to affect the accuracy of self-reporting. | Posted | Count of Units | Nights | 1 night (approximately 8 hours) | Nights | Nights |
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| Secondary | Number of Position Changes | To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the number of times the participant changed body position (e.g., supine to left side) per the participant's self report and is compared with the number of times the participant changed body position per the polysomnography data. | Only 15 participants completed this question; each of these spent 2 nights in the sleep lab (1 PrenaBelt night and 1 sham PrenaBelt night), which is 30 nights (30 self-reports and 30 polysomnography reports). The Arms/Groups are combined in this analysis because the treatment order was not expected to affect the accuracy of self-reporting. | Posted | Median | Inter-Quartile Range | position changes | 1 night (approximately 8 hours) | Nights | Nights |
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| Secondary | Percentage of Total Sleep Time in Each Position | To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the percentage (%) of total sleep time in each position (left, supine, right, prone) per the participant's self report and is compared with the percentage (%) of total sleep time in each position (left, supine, right, prone) per the polysomnography data. | Of 18 participants that answered this question, all except 1 of these participants answered it on both nights, which yields 35 nights (35 self-reports and 35 polysomnography reports). The Arms/Groups are combined in this analysis because the treatment order was not expected to affect the accuracy of self-reporting. | Posted | Mean | Standard Deviation | percentage of sleep time (%) | 1 night (approximately 8 hours) | Nights | Nights |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Sham PrenaBelt on First Night, PrenaBelt on Second Night | These participants were randomized to receive the sham-PrenaBelt on first night, and the PrenaBelt on second night. PrenaBelt: The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT. The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back of the user when she lies on her back, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back. Sham PrenaBelt: The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points. | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005315 | Fetal Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D012919 | Social Behavior |
| D001519 | Behavior |
| RDI while non-supine |
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| REM minimum |
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| NREM maximum |
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| NREM mean |
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| NREM minimum |
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| Right |
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| Prone |
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| Right |
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| Prone |
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| Right |
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| Prone |
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