Modifying Maternal Sleep Position in the Third Trimester of Pregnancy With Positional Therapy: A Randomized Pilot Trial
Phase: NA
Conditions: Sleep, Pregnancy, Stillbirth, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Fetal Growth Retardation, Fetal Hypoxia
Sponsor: Allan Kember

Cover Page 
Research Protocol 
 
Official Title: Modifying Maternal Sleep Position in the Third Trimester of Pregnancy with 
Positional Therapy: A Randomized Pilot Trial 
 
NTC02377817 
 
Document Date: 15MAR2016 
 

 
 
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March 15th, 2016 
To:  
 
The IWK Health Centre – Research Ethics Board 
 
 
Research Services, Richard Goldbloom Gallery, Main Floor 
 
 
5850/5980 University Avenue, Halifax, NS, B3K 6R8 
From:  
 Allan Kember 
Research Administrator, Global Innovations for Reproductive Health and Life 
Project Lead, Grand Challenges Canada Grant #S7 0629-01-10 
 17 Oceanview Dr. 
 Halifax, NS, B3P 2H4 
Subject:  
Research Protocol 
Project Title:  
A Maternal Device for the Prevention of Stillbirth and Low Birthweight 
Study Title:  
Modifying Maternal Sleep Position in the Third Trimester of Pregnancy with 
Positional Therapy: A Randomized Pilot Trial 
Foreword 
This project, entitled A Maternal Device for the Prevention of Stillbirth and Low Birthweight, was 
originally submitted on March 10th, 2014 to Grand Challenges Canada in response to their Request for 
Proposals: Stars in Global Health – Round 7 Phase I. Grand Challenges Canada’s peer review of this 
proposal was led by the Canadian Institutes of Health Research. This proposal was recommended to 
proceed to the next stage of the Stars in Global Health grant process, which involved due diligence and 
grant agreement negotiations between the primary organization for this project, Innovative Canadians 
for Change Foundation (ICChange – Edmonton, AB), and Grand Challenges Canada, which were 
completed on December 19th, 2014. Funding for this project was approved on December 19th, 2014. 
Note that this proposal includes two feasibility studies – one in Halifax, Canada, and one in Accra, 
Ghana. Both studies include human participants; therefore, both studies will require ethics approval. For 
the study in Halifax, ethics approval was received on June 16th, 2015 (Project #1018753) from The IWK 
Health Centre Review Ethics Board (REB). For the study in Accra, ethics approval was received from The 
IWK-REB on June 16th, 2015 (Project #1019318) and from the Noguchi Memorial Institute for Medical 
Research Institutional Review Board (local ethics board) on March 4th, 2015 (CPN 069/14-15). 
The purpose of this document is to set forth the research protocol for the study related to The IWK 
Health Centre in Halifax, Canada as per the guidelines given in the document Protocol Components 
provided under the New Submissions – Guidelines and Templates section of the IWK Health Centre 
Research website: 
http://www.iwk.nshealth.ca/research/application-materials-forms 

 
 
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This research protocol is submitted for review by The IWK Health Centre’s Review Ethics Board as part of 
the requirements in the document Researcher’s Checklist for Submissions: Delegated Review. 
This document is divided into two main sections. The first section – “Scientific” – describes the scientific 
aspect of the study. The second section – “Ethical” – describes the ethical aspect of the study. 
Sincerely, 
 
Allan Kember 
 
 

 
 
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1 Scientific 
1.1 Introduction 
According to the WHO, stillbirth (SB) is defined as fetal death at gestation ≥28 weeks or weight ≥1000g 
[1]. In Canada, the definition of SB is wider, including fetal death at gestation ≥20 weeks or weight ≥500g 
[2]. In addition to the loss of life for the stillborn baby, SB assails parents with psychological grief of 
losing their baby and results in markedly increased mortality when compared with non-bereaved 
parents [3]. Current risk factors for SB in high-income countries are well established and documented. In 
a recent systematic review with meta-analysis [4], the three most important modifiable risk factors for 
SB were found to be obesity (population attributable risk (PAR) 8-18%), advanced maternal age (PAR 6-
8%), and smoking (PAR 4-7%). Of these, smoking is the only modifiable risk factor that can be realistically 
addressed during the course of a pregnancy. 
Low birthweight (LBW) is defined as a weight less than 2500g at birth [5]. LBW is a significant 
contributor to SB [4], and infants with LBW are 20 times more likely to die in the first year than heavier 
babies [5]. Although LBW babies constitute only about 15% of live births, they account for 60-80% of 
neonatal deaths [6] [7] [8] [9]. Neonatal deaths (death within the first year of life) account for 40% of all 
deaths under the age of five years [10]. LBW also accounts for significant morbidity such as cognitive 
impairment [11], and chronic diseases later in life [5] [12]. LBW arises through short gestation (preterm 
birth) or in-utero growth restriction, or both [13]. 
Maternal sleep position during pregnancy has recently emerged as a risk factor for LBW and SB [14] [15] 
[16]. A device to modify maternal sleep position and mitigate this risk factor has been developed (see 
section 1.1.3). The purpose of this Stars in Global Health project is to test the effectiveness of this device 
and assess the feasibility of incorporating this device into an antenatal care clinic in Ghana. Data will be 
used in effect size calculations for large-scale trials targeted at reducing poor pregnancy outcomes in 
Canada and worldwide. 
1.1.1 Research Problem 
In 2009, the World Health Organization reported the global prevalence of stillbirth (SB) to be 2.6 million 
(uncertainty range: 2.1-3.8 million), of which 98% occur in countries of low and middle income [1] – see 
Figure 1. Sub-Saharan Africa has the highest rate of SB worldwide and has made the least progress in SB 
reduction [1]. Little is known about effective interventions for SB, especially those that can be 
implemented in resource-limited settings. 
In addition to the global burden of SB, the global incidence of LBW infants remains a significant public 
health challenge. Each year, there are over 20 million infants born with LBW, of which 96% occur in 
developing countries with the highest concentrations in Asia and Africa [5] – see Figure 1.  Efforts to 
reduce the incidence of LBW have not been successful in these regions, and thus the incidence has 
remained largely unchanged [5]. 
Low- and middle-income countries urgently require simple, inexpensive, and effective interventions to 
reduce the rates of SB and LBW. 

 
 
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Figure 1. Maps of global stillbirth and low birthweight rates. Data source: World Health 
Organization, 2009. 
1.1.2 Background – Maternal Position 
In obstetrics, it is well-known that when a pregnant woman assumes the supine position during the day, 
maternal cardiovascular parameters [17] [18] [19] and/or fetal oxygenation [20] are altered, often 
causing fetal distress, particularly during labour [21]. However, until recently, there has been little 
evidence on the effect of supine position during sleep in pregnancy. Recently, three studies have 
suggested that maternal sleep position may be a risk factor for SB [14] [15] [16] and LBW [16]. This is 
significant given that the majority of third trimester pregnant women spend up to 25% of their sleep 
time supine [22]. In the Auckland Stillbirth Study [15], the population attributable risk (PAR) for non-left 
sleep position was found to be 37%, which is greater than the PARs of the three most important 
modifiable risk factors for stillbirth (obesity, advanced maternal age, and smoking) combined [4]. In an 
African population [16], the newborns of women who reported supine sleep during pregnancy were at 
increased risk of low birth weight (OR, 5.0; 95% CI, 1.2–20.2; P=0.025) and stillbirth (OR, 8.0; 95% CI, 
1.5–43.2; P=0.016) with a logistic regression that controlled for the covariates maternal age, gestational 
age, parity, and the presence of pre-eclampsia. Notably, low birth weight was found to mediate the 
relationship between supine sleep and stillbirth [16]. Currently, there is much interest [23] and follow up 

 
 
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research occurring worldwide, with a growing body of evidence regarding the detrimental effects of 
supine sleep position on pregnancy outcomes [24]. 
One proposed hypothesis is that the maternal supine position during sleep plays a causative role in LBW 
and SB via compression of the abdominal aorta and inferior vena cava (‘aortocaval compression’), 
resulting in negative sequelae. In 2014, drawing on the triple risk model that has been useful in 
understanding the pathogenesis of sudden infant death syndrome, Warland and Mitchell [25] proposed 
a similar triple risk model (see Figure 2) to explain the inter-relationship between risk factors and 
stressors that may result in SB. Although any one risk factor may be insufficient to cause death, together 
they may produce a lethal combination (as represented by the intersection of the circles), particularly if 
the fetus is vulnerable [25]. Examples of factors and stressors for each circle are: 
• 
Placental and Fetal vulnerability – e.g., intrauterine growth restriction, placental insufficiency. 
• 
Maternal factors – e.g., obesity, advanced maternal age, smoking 
• 
Fetal stressors – e.g., maternal aortocaval compression, umbilical cord compression 
 
Figure 2. Triple risk model for unexplained 
late stillbirth [25]. 
We consider that by addressing these factors and preventing their intersection, we may protect the 
vulnerable fetus from LBW or SB and thereby effect a significant reduction in the global rates of LBW 
and SB. In this Stars in Global Health project, we focus on how we may intervene to reduce the 
likelihood of a fetal stressor occurring, in particular maternal aortocaval compression caused via the 
maternal supine sleeping position. 
1.1.3 Background – Maternal Device 
Some pregnant women sleep with many pillows supporting their body, including a pillow behind their 
back to avoid the supine position. Asking women to sleep on their left increases the percentage of left 
sided sleep to approximately 60% of the night; however, this may come at a cost of a slightly reduced 
sleep duration, perhaps due to the women feeling they need to make a conscious effort to maintain 
sleep position [26].  

 
 
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Maternal sleep position has recently been implicated as a potential modifiable risk factor for LBW and 
SB [14] [15] [16]. Hence, a simple, low-cost, and easily-implemented device has been developed for use 
by pregnant women to mitigate this risk factor. We anticipate that using this device will remove the 
need for the woman to make a conscious effort to avoid the supine sleeping position. The device name 
is ‘PrenaBelt’. The PrenaBelt is currently at the prototype stage of development, and as such, this 
proposal is a proof-of-concept/feasibility project.  
The PrenaBelt is a belt-like, positional therapy 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 
positional therapy. Positional therapy is a simple, non-invasive, inexpensive, long-established, safe, and 
effective intervention for preventing people with positional-dependent snoring or mild to moderate 
obstructive sleep apnea from sleeping on their back [27] [28] – a position that exacerbates their 
condition [29] [30] [31] [32]. 
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 around the midriff (back and right side) of the user when 
she lies on her back or right side, respectively. These subtle pressure points activate her body’s natural 
mechanism to spontaneously reposition itself to relieve discomfort [33] [34] [35], thereby reducing the 
amount of time she remains on her back or right side. Alternatively, the PrenaBelt can be worn at the 
level of the thorax with the back of the device centered at the mid-back, in which case the front of the 
device would sit just below the breasts at the level of the fundus (upper abdomen). 
The PrenaBelt is also designed for adjustability and comfort. As such, its configuration can be easily 
adapted by the user to only help her avoid sleeping on her back if she requires the option of sleeping on 
her right side as well as her left for comfort reasons. 
Members of our team at Global Innovations for Reproductive Health and Life (GIRHL, Cleveland) have 
developed a Body Position Sensor (BPS) to be integrated into the PrenaBelt. The BPS is a small, 
electronic data acquisition device developed for research purposes only and in accordance with the 
original proposal to our funder, Grand Challenges Canada. The BPS fits into a pocket on the PrenaBelt 
and uses a three axes accelerometer to detect orientation of the PrenaBelt, and thus the user, in three-
dimensional space. The accelerometer data is collected and stored on the BPS hard drive and can be 
accessed via connecting it to a computer. 
The PrenaBelt only comes into contact with intact skin and, as such, is a non-invasive medical device. As 
per Rule 7, subrule (1) in the Government of Canada’s Medical Devices Regulation – Classification Rules 
For Medical Devices, the PrenaBelt is classified as a Class I medical device [36]. The BPS is a research-use 
only device and, as such, does not fall under medical device regulation.  
Per the Government of Canada’s Medical Devices Regulation – Part 3: Medical Devices For 
Investigational Testing Involving Human Subjects, Section 80, Subsection (3), “A manufacturer or 
importer of a Class I medical device may sell the device to a qualified investigator for the purpose of 
conducting investigational testing if the manufacturer or importer possesses records that contain all the 

 
 
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information and documents required by Section 81” [36]. Note that the information and documents 
required by Section 81 can be found in the Product Information document. 
To date, no studies have investigated positional therapy in the pregnant population, and no positional 
therapy devices have been designed specifically for pregnant women (see Attachment 1). This is likely 
because the association between maternal sleeping position and adverse pregnancy outcomes has only 
recently been discovered and published in the literature [14] [15] [16]. The only FDA-approved product 
for treatment of positional dependent snoring and mild obstructive sleep apnea is the Zzoma Positional 
Sleeper by Sleep Specialists, LLC (Abington, PA) [37]. However, the Zzoma device was designed 
specifically for patients with positional-dependent snoring and mild obstructive sleep apnea and not for 
pregnant women, who are notably different in many aspects including anatomy (e.g., the gravid uterus) 
and nocturnal behaviour (e.g., rising up more often during the night). 
1.1.4 Hypotheses 
The following are hypotheses for the study proposed for Halifax: 
1. When compared to one night of sleep with no positional therapy (PT) treatment, treatment with 
a PT intervention (PrenaBelt) during one night of sleep in the third trimester of pregnancy will 
significantly reduce the percentage of time spent in the supine and right-lateral positions and, 
thereby, have a favourable effect on maternal respiratory and cardiovascular parameters. 
2. Maternal satisfaction, comfort, and desire to continue use of the PrenaBelt during third 
trimester sleep will be acceptable1 after one night of use. 
1.2 Relevant Literature 
Below, is a list of additional relevant literature that has not been discussed in this research protocol. 
1.2.1 Maternal Sleep Practices as Risk Factors for Adverse Pregnancy Outcomes 
Romero R and Badr MS. A role for sleep disorders in pregnancy complications: challenges and 
opportunities. American Journal of Obstetrics & Gynecology, 2014; DOI: 
http://dx.doi.org/10.1016/j.ajog.2013.11.020 
O’Brien LM, Bullough AS, Owusu JT, Tremblay KA, Brincat CA, Chames MC, Kalbfleisch JD, and Chervin 
RD. Snoring during Pregnancy and Delivery Outcomes: A Cohort Study. Sleep, 2013; 36(11):1625-1632. 
1.2.2 Sleep Position and Polysomnography During Pregnancy 
O’Brien LM, Bullough AS, Shelgikar AV, Chames MC, Armitage R, and Chervin RD. Validation of Watch-
PAT-200 Against Polysomnography During Pregnancy. Journal of Clinical Sleep Medicine, 2012; 8(3):287-
294 
                                                          
1 “Acceptable” for each of these measures (satisfaction, comfort, intention to use) is defined independently for 
each measure as being rated 5 out of 10 or higher on a scale from 1 to 10 on the PrenaBelt User Feedback 
Questionnaire. Each measure has a note indicating the user’s subjective evaluation correlated with various 
numbers on the scale.  

 
 
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1.2.3 Stillbirth and Low Birthweight 
Bukowski R, et al. Fetal Growth and Risk of Stillbirth: A Population-Based Case-Control Study. PLOS 
Medicine, 2014; 11(4)e1001633 
1.2.4 Positional Therapy (as a Treatment Option for Sleep Disordered Breathing) 
Jokic R, Klimaszewski A, Crossley M, Sridhar G, and Fitzpatrick MF. Positional treatment vs continuous 
positive airway pressure in patients with positional obstructive sleep apnea syndrome. Chest, 1999; 
115(3):771-781 
Skinner MA, Kingshott RN, Filsell S, and Taylor DR. Efficacy of the ‘tennis ball technique’ versus nCPAP in 
the management of position-dependent obstructive sleep apnoea syndrome. Respirology, 2008; 
13(5)708-715 
Permut I, et al. Comparison of positional therapy to CPAP in patients with positional obstructive sleep 
apnea. Journal of Clinical Sleep Medicine, 2010; 6(3):238-243 
1.3 Feasibility Study Objectives 
The following are objectives for the study proposed for Halifax: 
1. Compare maternal sleep position in third trimester pregnant women between a night with and a 
night without a positional therapy (PT) intervention (PrenaBelt). 
2. Obtain PrenaBelt user experience feedback to evaluate PrenaBelt feasibility and acceptability 
and optimize PrenaBelt design for future research. 
1.4 Research Design and Methodology 
In Halifax, 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 positional therapy (PT) and one night with sham-PT to determine 
treatment effect on outcomes2. 
• 
Randomized: participants will be randomized to treatment order: sham-PT on first night, then 
true 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 feel, fit, and form of the true PT device 
but without the ability of function (pressure points) will be used as a control. The purpose of a 
                                                          
2 These nights need not be consecutive as this may be onerous on some participants who may have children at 
home; therefore, we will accommodate the schedule and wishes of the participants in the sleep test booking. 

 
 
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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 a that device 
(e.g., function). Note that there is no established effective therapy for the population for the 
indication under study. 
• 
Triple-blind: participants, research assistants monitoring and sleep technologists scoring the 
sleep tests, and the specialized sleep physician reviewing and reporting the sleep test results will 
be blinded to the intervention – PrenaBelt or sham-PrenaBelt – received each night. 
• 
Laboratory: conducting this study in a controlled lab setting will allow for continual, real time 
monitoring of various cardiovascular, respiratory, uterine, and sleep parameters of each 
participant by the research assistant. This contributes to a more controlled and safer study 
overall. 
• 
Sleep Test: body position, various cardiovascular and respiratory parameters, uterine 
contractions, and sleep staging 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. 
1.4.1.1 Methods 
After the recruitment, consent, and enrolment processes (see Section 2.5), each participant will be 
contacted by a researcher and booked for two overnight sleep tests at the Capital Health Sleep 
Disorders Clinic (4th floor, Abbie J Lane Building, QEII Hospital, 5909 Veterans Memorial Lane, Halifax, 
NS). These sleep tests will be booked to take place late in her pregnancy (28-37 weeks) but not beyond 
37 weeks unless she is comfortable doing so. These two tests need not be consecutive nights as this may 
be onerous on the participants, who may have children at home; we will accommodate the schedules 
and wishes of the participants. The sleep clinic has two beds that can be dedicated to research; 
therefore, two participants should be booked into the clinic per night for budgetary reasons: two 
participants can be monitored by one research assistant in a twelve hour shift (see section 1.7). 
Each participant will be told that she will be randomized by the researchers to which intervention – 
PrenaBelt device or sham-PrenaBelt – she will receive on the first night and not informed of the 
treatment order. On the second night, each participant will be switched over to the alternate 
intervention. Since the PrenaBelt and sham-PrenaBelt will be virtually identical (except for functional PT 
capability), each participant will be essentially blinded to the intervention received on each night. The 
PrenaBelt and sham-PrenaBelt will be randomly labeled as either “Device A” or “Device B” by one of the 
researchers not directly involved in sleep test monitoring, scoring, interpretation, or reporting. The 
research assistant monitoring and sleep technologist scoring the sleep tests and the sleep specialist 
physician interpreting and reporting the results will be blind to the intervention used on each night 
because they will not be told the true identification of “Device A” and “Device B”. As such, this triple-
blind, cross-over, sham-controlled design enables each participant to serve as her own control and 
measurements/results can be compared between her sleep tests. 
In preparing for the sleep tests, each participant will be directed to follow the instructions within the 
Information and Consent Form, which are standard instructions that the sleep clinic has published on its 
website: 

 
 
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• 
Participants will be asked to not drink alcohol on the days of their sleep tests. 
• 
Participants will be asked to not drink or eat caffeine after 5:00pm on the days of their sleep 
tests. 
• 
Participants will be informed that there will be healthy snacks and beverages available at the 
sleep clinic at no cost to them. 
• 
If a participant becomes sick with a cold, flu, chest infection or any other physical/medical 
disorder that could interfere with her sleep, she will be asked to contact a member of the study 
team as soon as possible as her sleep tests may need to be rebooked.  
• 
Participants will be asked to try to maintain their regular daytime schedule and, if at all possible, 
avoid napping on the days of their sleep tests. 
• 
Participants will be asked to bring all of their regular medication to the sleep clinic. Unless 
otherwise instructed beforehand, participants should continue to take their medication as usual. 
• 
Participants will be required to wear sleep attire and will be asked to try to avoid silky material. 
Pajamas, or walking shorts and a t-shirt are ideal. Participants can bring their own pillow and/or 
favorite blanket if they wish. 
• 
To ensure the paste and tape for the various monitors adhere to the participant’s skin, 
participants will be discouraged from using body and facial moisturizers. Participants will be 
asked to remove artificial fingernails and nail polish from at least one finger before the test as 
they prevent the function of the pulse oximeter. 
• 
Presently, the sleep clinic does not have shower facilities but is able to provide participants with 
face cloths and towels. If participants wish to have access to shampoo, soap and 
combs/brushes, they will be asked to bring their own. 
• 
Participants will be encouraged to bring reading material, puzzles, a movie (on DVD) or some 
other interest to help them relax before Lights Out. The sleep clinic has portable DVD players 
that participants can borrow. 
• 
Onsite underground parking is available and presently costs $4.00 for an overnight stay (in after 
4:30pm, out before 8:00am). Participants will be reimbursed for this if they choose overnight 
parking. 
The following are the specific details about how the sleep test will proceed: 
• 
Sleep tests will be done in a private clinical/research room with continuous monitoring by a 
research assistant (in a separate room) through audio-visual and Sandman sleep software. 
• 
Participants (1-4 per night) will be asked to arrive at the sleep clinic waiting room between 
7:00pm and 8:00pm on the evenings of their sleep tests. The research assistant and/or study 
personnel will meet the participants in the waiting room, provide them with two forms to 
complete (below, first sleep test night only), and bring them to their respective rooms. 
o Participants will be asked to complete the Unexpected Events Contact Form and give it 
to the research assistant. This will only takes a few minutes to complete. 
o Participants will be asked to complete the Data Collection Form. This form will take 
about 5-10 minutes to complete. This form will be placed in a sealed envelope for the 
researchers. 

 
 
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o The forms can be completed before or after hook up. 
• 
The research assistant will hook up one participant at a time. Several monitors (explained 
below) will be attached to each participant. Hook up will be according to the American Academy 
of Sleep Medicine 2014 guidelines. Monitors and software will be used to measure, record, and 
process the following information during the sleep tests: 
o Body position will be measured by direct observation by the research assistant through 
audio/video recording and by an electronic Body Position Sensor incorporated into the 
PrenaBelt. 
o Apnea-hypopnea index, which is a standardized measurement of how many times the 
breathing pauses or slows during sleep, will be calculated by measuring: 
▪ 
Chest and abdominal movement (respiratory effort) by having the participant 
wear two soft, stretchy belts with sensors (respiratory inductance 
plethysmography). One belt will be positioned around the rib cage just below 
the breasts, and one belt will be positioned near the umbilicus. 
▪ 
The airflow through the participant’s mouth and nose by a soft, rubber tube 
placed just under the nares at its opening, which measures inspiration and 
expiration. This tube will also detect if snoring is present and how much.  
o The arterial oxygen saturation will be measured by a pulse oximeter placed on one of 
the participant’s fingers. 
o Heart rate and regularity will be measured by electrocardiography (EKG), which involves 
attaching two electrodes to the skin on the chest and using wires and tape to connect 
the electrodes to the central box for signal processing. 
o Sleep staging (wake, stage 1, 2, 3, and REM) will be measured by a combination of EEG, 
EOG, and EMG, which involves attaching electrodes, tape, and wires (similar to above) 
to the skin on the head, face, chin, neck, arms, and legs.  
• 
The research assistant and/or study personnel will use a demonstration PrenaBelt to show the 
participant how to don and doff the PrenaBelt. The participants will be informed that they can 
remove the PrenaBelt and/or sleep test equipment at any point of the sleep test if they become 
too uncomfortable. 
• 
Bathroom visits during sleep tests are always possible. The research assistant and/or study 
personnel will discuss the bathroom visit process with participants before their sleep test. 
Bathroom breaks during sleep tests are part of routine practice at the sleep clinic. The research 
assistant will assist the participants when bathroom breaks are required and ensure privacy. 
• 
The research assistant will not be apprised of whether the participant has been assigned the 
PrenaBelt or sham-PrenaBelt. The study personnel will place the appropriate device in a box in 
the participant’s room. The participant will open the box and put on the PrenaBelt before lights 
out.  
• 
The PrenaBelt will be preconfigured for the participant by the study personnel based on 
whether the participant indicated to the IWK Research Assistant that she would like the option 
of sleeping on her right side. If the right side sleeping position is requested, the balls will be 
removed from the pockets on the right side of the PrenaBelt. When the balls are removed from 

 
 
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the right side pockets, the configuration of the PrenaBelt as such will then only help the user 
avoid sleeping on her back. 
• 
Lights Out is usually between 10:30pm to 11:00pm. Just before lights out, the research assistant 
will run calibration testing, which requires participation from the participants (e.g., “close your 
eyes, open your eyes, roll your eyes, look left, look right, clench your teeth, breath through your 
mouth, breath through your nose, hold your breath and move your belly in and out,…”). The 
research assistant will monitor the incoming sleep data in real time throughout the night for 
quality assurance.  
• 
If a channel faults, the research assistant may fix it if the participant is still awake or wakes up 
for a bathroom break. If the research assistant cannot solve the fault, he/she may consult with 
the sleep technician (if present) or call the on-call sleep technician (Friday and Saturday 
evenings). Throughout the night, the research assistant may also add notes to the data that may 
assist with subsequent scoring of the data.  
• 
If the device (PrenaBelt or Sham-PrenaBelt) cannot be tolerated by the participant and is 
removed during the sleep test (note that the Information and Consent Form clearly informs the 
participants that they are free to remove the device at any time at no penalty if it becomes too 
uncomfortable), this will be noted by the research assistant via the Sandman software. The 
sleep test data recording will continue until morning. Study personnel will follow up with the 
participant to determine whether or not she wishes to withdraw from participating in the study. 
• 
The sleep tests will be finished between 6:00am and 6:30am. When the participant awakes, the 
research assistant will enter the room and unhook the participant from the sleep test 
equipment. It is expected that participants will be out of the sleep clinic bedrooms by 7:00am 
whenever possible. 
• 
After participants are unhooked and before they leave the sleep clinic, they will be asked to 
complete the PrenaBelt User Feedback Questionnaire, which will take 5-10 minutes and will be 
sealed in an envelope for the researchers. 
1.4.1.2 Measures 
The information collected from her on the Data Collection Form is collectively referred to as 
“demographic and sleep habits information” in Section 1.4.1.6: 
o 
Gestational age at time of sleep test 
o 
Parity 
o 
Maternal age 
o 
Ethnicity/race 
o 
BMI (weight, height) at time of sleep test and BMI at conception or early pregnancy  
o 
Typical bed and rise times, usual sleep duration, habitual snoring (3 or more nights per 
week; if present, for how long this has been the case), typical position she goes to sleep in 
and wakes up in currently and when she is not pregnant, what part of the bed she sleeps 
on, if she has a bed partner, and if she uses pillows when she sleeps (if so, how) 
o 
Presence of new pregnancy-related conditions since signing the consent form for this study 
 

 
 
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For each participant, identical measurements (below, collectively referred to as “sleep variables” in 
Section 1.4.1.6) will be recorded on both nights using the same methods, equipment, and software. The 
sleep tests will be set up and monitored by a research assistant trained in polysomnography and under 
the supervision of a sleep technologist except on Friday and Saturday evenings. On Friday and Saturday 
evenings, either two research assistants will be present or one research assistant and one authorized 
study personnel will be present and a sleep technician will be on call. The sleep tests will be scored by a 
sleep technologist holding board certification in sleep technology (RPSGT). Scoring will be according to 
the current American Academy of Sleep Medicine Manual for the Scoring of Sleep and Associated 
Events. The sleep tests and scores will be interpreted and reported by a sleep specialist physician. Note 
that the measurements, methods, equipment, and software employed will be non-invasive: 
a. Maternal position: direct observation by the sleep technologist through real-time or 
recorded audio/video and by an electronic Body Position Sensor incorporated into the 
PrenaBelt 
b. Chest and abdominal respiratory movement: respiratory inductance plethysmography 
(RIP) via Pro-Tech zRIP DuraBelt with Sandman PSG software 
c. Nasal and oral airflow and presence of snoring: Braebon nasal pressure transducer. If 
the participant is a total mouth breather, Braebon thermistor will be available as a back-
up.  
d. Arterial blood oxygenation: pulse oximetry (SpO2) via Embla Sandman 
e. Heartbeat rate and regularity: via electrocardiography (EKG) 
f. Sleep staging: via electroencephalography (EEG), electromyography (EMG), and 
electrooculography (EOG). Note that if a participant is uncomfortable or cannot tolerate 
some of the EEG, EMG, or EOG electrodes/leads, e.g., EMG electrodes/leads on arms 
and legs, these electrodes/leads may be removed. 
In the morning following each sleep test, before each participant is discharged home, she will be asked 
to complete the approved PrenaBelt User Feedback Questionnaire and seal it in a provided envelope for 
the researchers. Participants will be asked: 
a. 
What position she adopted upon settling down last night 
b. 
What position she fell asleep in last night 
c. 
What position she woke up in this morning 
d. 
If she changed position during night 
e. 
If she remembers changing positions 
f. 
Her level of satisfaction with the PrenaBelt as it relates to the quantity and quality of her 
sleep last night 
g. 
Her level of comfort while wearing and sleeping with the PrenaBelt 
h. 
Her intention to use the PrenaBelt for the remainder of her pregnancy if it was available 
to her 
i. 
Any suggestions of changes/ modifications/ improvements she may have for the 
PrenaBelt 

 
 
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1.4.1.3 Outcomes 
Primary Outcomes: For both sleep tests, the following are the primary outcomes for each participant:  
• % of time spent in the supine and right-lateral positions with each intervention 
• PrenaBelt User Feedback Questionnaires 
The following data will be collected from each participant across each intervention and serve as pilot 
data to inform effect size calculations for future research.  
• Apnea Hypopnea Index (AHI) 
• Arterial blood oxygenation (SpO2) 
• Maternal heart rate (ECG) 
• Sleep parameters (total sleep time, presence of snoring, RDI, sleep onset latency, sleep 
efficiency, sleep quality, number of arousals, number of position changes, mean AHI while 
supine, mean SpO2 while supine) 
When the two sleep tests are complete (interpreted and reported by the sleep specialist physician), the 
results will be provided to the participant’s maternity care physician who will discuss her results with her 
at her next antenatal care visit. If warranted by the results of the sleep tests for a given participant (e.g., 
severe obstructive sleep apnea is discovered), contact will be made with the participant and her 
maternity care physician by a researcher to allow for proper management and care at the earliest 
opportunity. If her maternity care physician has any concerns about the sleep test results and plan for 
further investigation/management, he/she may consult with Dr. Debra Morrison (Site-Investigator, 
Respirologist, Sleep Specialist Physician) who will be available to address these concerns. 
1.4.1.4 Inclusion/Exclusion Criteria 
Inclusion criteria: ≥18 years old, low-risk singleton pregnancy, in the last trimester of pregnancy (≥28 
weeks of gestation), and residing in the Halifax Regional Municipality. 
Exclusion criteria: BMI ≥ 35 at booking (first antenatal appointment for current pregnancy), pregnancy 
complicated by obstetric complications (hypertension [pre-eclampsia, gestational hypertension, chronic 
hypertension], diabetes [gestational or not], or intra-uterine growth restriction [<10th %ile for growth]), 
sleep complicated by medical conditions (known obstructive sleep apnea, known to get <4 hours of 
sleep per night due to insomnia, or musculoskeletal disorder that prevents sleeping on a certain side 
[e.g., arthritic shoulder]), multiple pregnancy, known fetal abnormality, non-English speaking and 
reading. 
1.4.1.5 Sample size 
To date, there has never been a positional therapy study performed on pregnant women [38]; 
therefore, there is little-to-no relevant data on which to base a proper sample size analysis. As a 
feasibility study, this study will be used to generate preliminary data to be used in effect size 
calculations for future clinical trials targeted at reducing poor pregnancy outcomes in Canada and 
globally. 

 
 
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A sample size of twenty-five3 (n=25) pregnant volunteers is selected for this feasibility study.  
Rationale:  
• 
For a one-sided paired t-test with power (β) of 0.80, significance level (α) of 0.05, n=25 pairs 
enable a detectable effect (d) of -0.5, which is a medium effect size per the literature regarding 
Cohen. 
• 
Based on expert opinion (Dr. Louise O’Brien, Scientific Mentor on Stars In Global Health project, 
University of Michigan), n=25 was originally budgeted and proposed to Grand Challenges 
Canada, which was subsequently approved by Grand Challenges Canada and the Canadian 
Institute for Health Research. 
1.4.1.6 Justification of Statistical Methods 
Cross-over study design: each participant is her own control for comparison.  
Descriptive statistics (mean, median, standard deviation, maximum, minimum) for demographic and 
sleep habits information and sleep variables (Section Error! Reference source not found.) will be 
reported.  
For continuous variables, the assumption of normality will be assessed using Q-Q plots and the 
Anderson-Darling test. If normal, paired t-test will be used for evaluating differences. If non-normal, 
Wilcoxon signed rank test will be used for evaluating differences. For dichotomous data, we will 
evaluate for differences using McNemar’s test for repeated measurements. 
1.5 Timeline 
November 2014 to May 2015: Halifax study preparation, PrenaBelt development and production of test 
samples, obtain ethical and research protocol approval from the IWK Health Centre REB. 
November 2015 to July 2016: Training, recruitment, consent, enrolment, and data collection in Halifax. 
July 2016 to August 2016: Data analysis, report writing, dissemination of findings from Halifax. 
 
November 2014 to May 2015: Ghana study preparation, obtain ethical and research protocol approval 
from Noguchi Memorial Institute for Medical Research IRB, IWK Health Centre REB, and the Ghana FDA. 
April 2015 to July 2015: Production of PrenaBelt test samples for Ghana study. 
July 2015 to January 2016: Training, recruitment, consent, enrolment, and data collection in Ghana. 
January 2016 to May 2016: Data analysis, report writing, dissemination of findings from Ghana. 
1.6 Definition of Adverse Events 
Labour is a natural process, so it will be classified as an unexpected event (not an adverse event) in this 
study should it begin to occur during a sleep test.  
                                                          
3 Note: the EAS Form submitted to the IWK states that a maximum number of thirty (n=30) participants will be 
recruited. The discrepancy of five (n=5) participants is a buffer to account for an approximate drop-out rate of 
20%. 

 
 
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Participants may experience minor irritation of skin in areas in contact with the stickers that hold the 
sleep electrodes on their body. 
The sleep tests for a given participant may reveal that an adverse event has been occurring in her 
pregnancy without prior knowledge. The sleep test may reveal the presence of maternal obstructive 
sleep apnea (OSA). We do anticipate that OSA will be discovered in some participants – especially since 
OSA is common yet often undiagnosed in pregnant women [39] [40] [41] [38] [42] [43] [44]. This adverse 
event is not related to this study, rather it is related to other obstetric and medical factors and only 
discovered by this study. It should also be noted that any events (e.g., OSA) that we do observe would 
be already occurring without anyone’s knowledge. If severe OSA is discovered during any of the sleep 
tests, we will notify the participant and her maternity care physician, give them the test results, and ask 
them to speak with one another at earliest opportunity to ensure proper management and care. Her 
maternity care physician will also be informed that if he/she has any concerns about the sleep test 
results and plan for further investigation/management, he/she may consult with Dr. Debra Morrison 
(Site-Investigator, Respirologist, Sleep Specialist Physician) who will be available to address these 
concerns. 
Should a medical emergency occur, the sleep technologists at the Capital Health Sleep Disorders Clinic 
have been trained according to internal policies and procedures for handling emergencies and 
unexpected events during sleep tests. The sleep technologists will call EMS and provide basic life 
support (if needed) until EMS arrives. The sleep technologists are trained in CPR.  
Although the risk is low, a participant may go into labour during the sleep study; therefore, our exclusion 
criteria excludes women at risk of pre-term labour, and we will not book any participants for a sleep test 
beyond 37 weeks gestation unless the participant is comfortable in doing so. The research assistant will 
follow a basic plan of action should the participant go into labour during a sleep test: 
1. 
If a participant begins labour during a sleep test, stop the test immediately. 
2. 
Urgent: if onset of labour is sudden and participant is in distress, call EHS to transport the 
participant to the IWK. Otherwise proceed to 3. 
3. 
Non-urgent: if onset of labour is slow and participant is stable, use the information from the 
Unexpected Events Contact Form and assist the participant in reaching her contact to 
transport her to the IWK. 
Pregnancy is associated with many risks for the mother and fetus, yet sleep tests are non-invasive and 
safe for pregnant women and their developing baby to undergo. Although the risks that this study poses 
to the pregnancy are minimal, all adverse events will be reported to the CDHA Patient Safety Reporting 
System as per hospital standard operating procedures. 
1.7 Budget 
For the budget related to research activities in the study in Halifax, see lines 77, 113, and 225 in the 
Project Budget (submitted as a component of the Researcher’s Checklist for Submissions: Delegated 
Review). 

 
 
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1.8 Resources 
Letters of support will be obtained from the applicable institutions (denoted by †) listed in Table 1 and 
submitted as a component of the Researcher’s Checklist for Submissions: Delegated Review.  
Table 1. Resources for Halifax Study 
Study Component 
Institution (Department) 
Key Personnel (Position) 
Lab/Facility 
Equipment 
Grant fund 
administration, 
Project Monitoring, 
and Advisory Board 
Innovative Canadians for 
Change Foundation 
Dr. Andre Isaac (Project 
Manager) 
n/a 
n/a 
Ethics Process 
IWK Health Centre 
(Review Ethics Board) 
Bev White (REB Manager/ 
Information Officer) 
n/a 
n/a 
Participant 
recruitment, consent, 
enrolment 
IWK Health Centre† 
(Women’s and Newborn 
Health) 
Dr. Heather Scott (Obstetrical 
Co-Director) 
Ms. Darlene Baxendale (RN, 
Research Assistant) 
Perinatal 
Centre 
n/a 
Sleep tests 
Capital Health† (Sleep 
Disorders Clinic) 
Dr. Debra Morrison (Clinical 
Director, Staff Respirologist) 
TBD (Certified Sleep 
Technologist) 
TBD (Polysomnography 
Research Assistant) 
Two sleep 
rooms in the 
sleep 
laboratory 
A/V equipment, Braebon  nasal 
pressure transducer, Braebon 
thermistor, Pro-Tech zRIP 
DuraBelt, Embla Sandman, 
Sandman PSG software, EKG, 
EEG, EMG, EOG, consumables 
PrenaBelt 
engineering, liaison 
with Kaishin Design 
Global Innovations for 
Reproductive Health and 
Life 
Ali Borazjani (President, Co-
Founder, Biomedical 
Engineer)  
n/a 
n/a 
PrenaBelt samples: 
design, production 
Kaishin Design 
Kaishin Chu (Apparel Design 
and Development 
Strategist/Consultant) 
n/a 
n/a 
Scientific Innovation 
University of Michigan 
Dr. Louise O’Brien 
n/a 
n/a 
Business Innovation 
Harvard Business School 
Dr. John McArthur 
n/a 
n/a 
n/a – ‘not applicable’ 
2 Ethical 
2.1 Potential Benefits to Participants and Others 
2.1.1 Participants in Halifax 
Undergoing a sleep test may benefit a participant and her developing baby. Due to physiological and 
anatomical changes in pregnancy, pregnant women have been found to be more susceptible to sleep-
disordered breathing – e.g., snoring, obstructive sleep apnea (OSA) – than non-pregnant women [38]. 
Possible association between OSA and complications in pregnancy (gestational diabetes, gestational 
hypertension, pre-eclampsia, intra-uterine growth restriction) have been shown [45] [39] [40] [46] [47], 
and OSA is common yet often undiagnosed in pregnant women [39] [40] [41] [38] [42] [43] [44]. After 
the sleep tests are scored for a given participant, a researcher will follow up with her maternity care 
physician if she requests this in the Information and Consent Form. Her maternity care physician will 

 
 
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discuss her results with her at her next antenatal care appointment. We have found in previous studies 
that most women appreciate this. 
If severe OSA is identified for a given participant, she and her maternity care physician will be notified 
immediately, given the sleep test results, and advised to discuss this issue together at earliest 
opportunity to ensure proper management and care. Proper management of her OSA may result in 
instant and long-term benefits for her and her baby. 
In addition, the opportunity to assist in the advancement of sleep-in-pregnancy knowledge and the 
possibility of benefiting other pregnant women globally in the future may be a source of immediate 
satisfaction to participants. 
2.1.2 Others 
Note: the following section refers to the WHO definition of stillbirth and not the definition used by 
Statistics Canada (see Section 1.1). 
In Canada, three babies are stillborn every day (≥1000g birthweight or ≥28 weeks completed gestation) 
[1]. This is a largely unrecognized national tragedy yet pales in comparison to Ghana, where 47 babies 
are stillborn every day [1] (Note: in Ghana, the birth rate is 2 times greater than that in Canada, but the 
stillbirth rate is more than 15 times greater). In addition, every day, 61 Canadian babies are born with 
low birthweight (≤2500g) [48], and 232 Ghanaian babies are born with low birthweight [49] – many of 
whom will die in infancy or suffer lifelong consequences. These statistics and disparities are 
unconscionable, yet even they pale when compared to regions of further impoverishment where the 
state of affairs has been aptly described by one author as ‘obstetric carnage’ [50].  
Maternal supine sleep has recently emerged as a potential risk factor for SB and LBW [14] [15] [16]. If 
supine sleep has a causative role in LBW and subsequently SB, the population attributable risk (PAR%) 
suggests that up to 17% of LBW, and consequently 26% of SB, might be averted by changing maternal 
sleep position [16] – this translates to the aversion of 3.7 million LBW and 676,000 SB annually [1] [5]. 
Since LBW is a major contributor to stillbirth [4], morbidity [5] [11] [12], and neonatal mortality (60-80%) 
[6] [7] [8] [9], further benefit may be realized. 
This study will test a novel approach to reducing the global incidence of SB and LBW by determining 
whether this potential risk factor can be mitigated via treatment with a simple, positional therapy 
device. Demonstrating that maternal sleep position is, in fact, amenable to positional therapy will be a 
valuable contribution to existing knowledge and may be a key component to reducing the rates of SB 
and LBW in Canada and worldwide.  
Currently, research is underway to determine whether a causal relationship between maternal sleep 
position and SB and LBW exists and collect a robust evidence base from which to advise whether a 
public health intervention should be considered (dissemination of research findings expected by August 
2016) [24]. If a public health intervention is advised, our study will be at the forefront of scientific 
investigation into one possible intervention, i.e., positional therapy. 

 
 
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Following successful completion of this proof-of-concept (Phase I) study, there is potential for transition-
to-scale (Phase II) funding from Grand Challenges Canada (contingent on 50% matching through 
partnerships) of up to $1,000,000 CAD for up to 2-3 years. In addition to this funding, other grant 
options in the area of maternal, newborn, and child health (MNCH) are available, e.g., Bill and Melinda 
Gates Foundation, Saving Lives at Birth. Such grants would enable exploration of the effectiveness of 
this intervention in populations that have very high perinatal mortality rates. 
Finally, this project may bring beneficial opportunities to members of the research team. For example, it 
may cultivate future research collaboration with other teams worldwide through publication in journals 
and presentations/networking at global health conventions. Another example is that the inventors of 
the PrenaBelt (Mr. Borazjani, Mr. Kember) plan to establish or partner with a social enterprise 
organization to ensure sustainability and maximum benefit to mothers and their babies globally. 
2.2 Potential Harms to Participants and Others 
This study is minimal risk. Participants in this study are at no greater risk of harms when completing the 
activities of this study than those risks they encounter in their everyday life. 
The PrenaBelt device is a non-invasive medical device of Class I designation (see section 1.1.3). Pregnant 
women typically sleep with many pillows supporting their body, including a pillow behind their back to 
avoid the supine position. The PrenaBelt is a positional therapy device that may assist pregnant women 
to avoid supine sleep. Positional therapy devices have been shown to be safe and approved for use by 
humans by the US Food and Drug Administration [37]. In addition, maternal body pillows, regular 
pillows, and pelvic belts (lumbar support) have been used by pregnant women during sleep without 
reports of serious adverse effects for the mother or neonate [51]. 
In Halifax, wearing the PrenaBelt and sleep monitoring equipment may be uncomfortable for a 
participant and disturb her sleep. Each participant will be told that she can remove these devices at any 
time overnight if she becomes too uncomfortable. 
In order to ensure the monitor electrodes remain adhered to participant’s skin, the research assistant 
will need to prepare the area of skin, which involves cleaning and slight abrasion with an abrasive skin 
preparation gel. In the morning, after the monitors are removed, participants may experience slight 
discomfort and redness on the regions of their skin that were in contact with the electrodes. Rarely, a 
person will have a minor skin reaction on the area of his/her skin that was in contact with the 
electrodes. This reaction is not dangerous and usually goes away on its own within 24 hours to a few 
days. 
Since personal information will be collected from participants, there always exists the potential harm 
should breach of confidentiality inadvertently occur. 

 
 
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2.3 Alternative Treatments or Procedures 
2.3.1 Positional Therapy 
There are several techniques used for positional therapy such as positional alarms, verbal instructions, 
special pillows, tennis balls, vests, and “shark fins”. The latter three techniques prevent the wearer from 
lying supine in a passive manner by applying pressure points to the wearer’s back when lying supine, 
which is similar to the mechanism of the PrenaBelt. 
To date, no studies have investigated positional therapy in the pregnant population, and no positional 
therapy devices have been designed specifically for pregnant women (see Attachment 1). This is likely 
because the association between maternal sleeping position and pregnancy outcome has only recently 
been published in the literature [14] [15] [16] [25]. 
There are several positional therapy products for persons with positional-dependent obstructive sleep 
apnea (POSA) (see Attachment 1). However, these devices are designed specifically for persons with 
POSA, not pregnant women, who may also have POSA but are notably different in aspects such as 
anatomy (e.g., the gravid uterus) and nocturnal behaviour (e.g., rising up more often during the night). 
Of these products, only the Zzoma Thoracic Anti-Supine Band is FDA-approved for the treatment of OSA. 
In addition, these devices are characteristically limited in that they are designed to only prevent supine 
sleep. Some of these devices involve expensive electronic components and, therefore, are not feasible 
for widespread deployment in low-resource areas.  
2.3.2 Sleep Study 
Sleep studies can be performed at home or in a sleep lab setting. Sleep studies for diagnosis of sleep 
disordered breathing in adults can vary in complexity. A Level I sleep study includes full 
polysomnography, is conducted in a sleep lab setting, and is considered the gold standard in sleep 
testing. A Level III sleep study is less complex and is generally performed in the home setting. In Halifax, 
we are proposing a Level I study. 
2.4 Minimization of Potential Harms 
While the risks of this study to the participants and their developing babies are minimal, all adverse 
events will be reported to the CDHA Patient safety Reporting System as per hospital standard operating 
procedures 
Wearing the PrenaBelt and sleep monitoring equipment may be uncomfortable for a participant and 
disturb her sleep. Each participant will be instructed how to, and told that she can, remove these 
devices and discontinue use at any time if she becomes too uncomfortable. If bothersome skin irritation 
occurs for a given participant as a result of contact with the electrodes, we will limit the contact of sleep 
electrodes to one overnight study. 
Personal health information (PHI) used to identify potential participants will not be accessed by anyone 
other than the researchers within their circle of care.  

 
 
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Upon enrolment in the study, each participant will be assigned a random, six-digit, alphanumeric code. 
All data collected from participants during the studies will be collected only in association with this code, 
thus automatically de-identifying the data and minimizing the risk of identification. The key to the code, 
which links the codes to patient names and contact information, will be kept in a secure location away 
from the de-identified study data, thus minimizing the risk of re-identification. The de-identified data in 
forms (paper) and files (electronic) will be secured in a locked filing cabinet and in password-protected 
files on a password-protected computer, respectively, in a locked office with limited access. 
For all study activities, all data collected from participants will be protected from unauthorized access to 
safeguard participant privacy and confidentiality in accordance with TCPS2, PHIPA, and PIPEDA and 
personal information policies at the IWK Health Centre.  
There is a reasonable foreseeable risk that the Unexpected Events Contact Form for a given participant 
(contains participant’s first name, name of contact, phone numbers of contact, and relationship of 
contact) could be matched with her Data Collection Form, PrenaBelt User Feedback Questionnaires, or 
sleep recording files (which contain her alphanumeric code) and be used to re-identify her de-identified 
information. To mitigate this risk of re-identification, the research assistant will be the only person who 
will have access to the Unexpected Events Contact Form and will be instructed to keep it in a separate 
secure location and shred it in a cross-cut shredder after the second sleep test is complete. In addition, 
the research assistant will not have access to the Data Collection Form or PrenaBelt User Feedback 
Questionnaires, which will be delivered and retrieved from each participant in a sealed envelope. 
Study data will only be exchanged in de-identified form and between authorized research team 
members per the approved EAS Form. Data will be protected in electronic transfers through password 
protection and encryption if deemed necessary. 
After study closure, study data will be stored securely (locked cabinets, password-protected files, 
password-protected computers, locked offices) in de-identified form for five years, after which it will be 
destroyed in a secure manner (e.g., incineration and cross-cut shredding). 
2.5 Process for Seeking Consent 
1. Ethical Approval and Training: The study requires approval from the Review Ethics Board at the 
IWK Health Centre (Halifax, Canada). All study personnel will be trained to the approved 
Research Protocol by Mr. Allan Kember (Sub-investigator, Project Lead).  
 
2. Recruitment:  
 
• 
The IWK OB/GYN will review charts of her/his patients scheduled for their routine antenatal 
visit at the clinic to identify potential participants. These patients will then be screened by 
the OB/GYN within their circle of care using the Screening Inclusion Form to determine if they 
meet the inclusion/exclusion criteria for this study. 
• 
Patients who meet the inclusion/exclusion criteria will be invited to participate in the study 
by their OB/GYN at the end of their antenatal care visit via the approved Flyer. The Flyer will 

 
 
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also be posted in the clinic rooms and waiting areas. A patient who expresses interest in 
participating in the study will be asked if she is agreeable to speak to the IWK Research 
Assistant about the study. 
o If she is agreeable, the IWK Research Assistant will then come to the clinic, confirm 
the inclusion/exclusion criteria by reviewing the patient’s chart, and conduct the 
formal consent process using the approved Information and Consent Form.  
o If she does not wish to speak with the IWK Research Assistant immediately but is still 
interested in participating in the study, she will be given the Information and Consent 
Form to take home and read and asked whether she would agree to be contacted by 
the IWK Research Assistant in one week’s time. 
▪ 
If she agrees, her name and contact information will be given to the IWK 
Research Assistant who will contact her in one week’s time to see if she is 
still interested in participating in the study. 
▪ 
If she does not agree, she will be informed that she is free to contact the IWK 
Research Assistant whenever she wishes to do so. 
• 
Snowball sampling may be used as well, i.e., potential participants who are interested may 
tell their friends about the study (share the Flyer and Information and Consent Form with 
them) and direct them to contact the IWK Research Assistant. 
  
3. Consent and Enrolment:  
• 
Potential participants, having  
o met the study inclusion/exclusion criteria, 
o been invited to participate in the study,  
o shown express interest in participating in the study, and 
o given verbal consent to speak with the IWK Research Assistant, 
will meet with the IWK Research Assistant to complete the consent process.  
• 
In the meeting, the IWK Research Assistant will go through the approved Information and 
Consent Form with the potential participant, ensuring full and accurate disclosure of the, 
o nature of the study (what is involved, who will be conducting it, how the results will 
be used, how confidentiality and privacy will be protected),  
o the risks and benefits involved in participating in the study, and  
o the free choice to decline participation in or withdraw from the study at any time 
without consequence (no adverse or negative effect on her or her family’s care in 
any way) 
to each potential participant.  
• 
The capacity of each potential participant to provide consent will be assessed by the IWK 
Research Assistant by asking the potential participant questions to verify she understands 
the information relevant to giving or refusing consent and appreciates the outcomes of both 
choices: 

 
 
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o What is this study about? 
o Why is this study important? 
o What will you need to do in this study? 
o What are the risks to you from being involved in this study? 
o What are the benefits to you from being involved in this study? 
o What happens if you choose to not participate today? 
o What happens if you choose to participate today and then change your mind at 
another time either before the study starts or during the study?  
• 
The IWK Research Assistant will give each potential participant an opportunity to ask any 
questions she may have. 
• Voluntary, written, informed consent (form) will be obtained by the IWK Research Assistant 
from a potential participant who has demonstrated capacity and maintains an interest in 
enrolling in the study. Authorization or refusal of consent by a potential participant will be 
accepted by the IWK Research Assistant. 
3 Bibliography 
[1] S Cousens, Hannah Blencowe, Cynthia Stanton, Doris Chou, and Saifuddin Ahmed, "National, 
regional, and worldwide estimates of stillbirth rates in 2009 with trends since 1995: a systematic 
analysis.," vol. 377, p. 1319, 2011. 
[2] Government of Canada. (2013, June) Table 11: Fetal deaths (20 weeks or more of gestation) and 
late fetal deaths (28 weeks or more of gestation), Canada, provinces and territories. [Online]. 
http://www.statcan.gc.ca/pub/84f0210x/2009000/t024-eng.htm 
[3] Mairi Harper, Rory C O'Connor, and Ronan E O'Carroll, "Increased mortality in parents bereaved in 
the first year of their child's life," BMJ Supportive & Palliative Care, vol. 1, pp. 306-309, 2011. 
[4] V Flenady et al., "Major risk factors for stillbirth in high-income countries: a systematic review and 
meta-analysis," Lancet, vol. 377, no. 9774, pp. 1331-1340, 2011. 
[5] United Nations Children's Fund and World Health Organization, "Low Birthweight: Country, 
Regional and Global Estimates," 2004. 
[6] A Bang, M H Reddy, and M D Deshmukh, "Child mortality in Maharashtra," Economical and Political 
Weekly, vol. 49, pp. 4947-4965, 2002. 
[7] Joy E Lawn, Simon Cousens, and Jelka Zupan, "4 million neonatal deaths: When? Where? Why?," 
Lancet, pp. 9-18, March 2005. 
[8] Sohely Yasmin, David Orsin, Elizabeth Paul, and Anthony Costello, "Neonatal mortality of low-birth-
weight infants in Bangladesh," Bulletin of the World Health Organization, vol. 79, pp. 608-614, 2001. 

 
 
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Attachment 1: Treatment and Device Search 
PrenaBelt Patent Search 
Positional Therapy for Positional-dependent Obstructive Sleep Apnea (POSA) – Product Search 
Pregnancy Sleep Product Search

 
 
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Table 1. PrenaBelt Patent Search 
Publication Number 
Application Number 
Publication 
Date 
Title 
Potential 
Similarity to 
PrenaBelt† 
US4471767 A  
US 06/558,335 
09/18/84 
Therapeutic device for positional treatment for gastroesophageal reflux 
1 
US20110132378 A1 
US 12/794,498 
06/09/11 
Systems and methods for controlling position 
2 
US 20110179573 A1 
US 12/975,144 
07/28/11 
Suspended back pillow for sustaining a side sleeping position 
1 
US 20130043999 A1 
US 13/695,209 
02/21/13 
Method and device for sleep posture correction 
3 
US 20120197340 A1 
US 13/251,856 
08/02/12 
Screening devices and methods for obstructive sleep apnea therapy 
1 
US 20130108995 A1 
US 13/286,037 
05/02/13 
System and method for monitoring and influencing body position 
1 
US 20100319131 A1 
US 12/581,732 
12/23/10 
Suspended Back Pillow for Sustaining a Side Sleeping Position 
1 
US4506396 A 
US 06/480,943 
03/26/85 
Comfort pillow for pregnant females 
1 
US 5359739 A 
US 08/113,076 
11/01/94 
Patient repositioning and position maintenance device 
1 
US6886201 B1 
US 10/698,244 
05/03/05 
Maternity pillow 
1 
USD547586 S1 
US 29/192,913 
07/31/07 
Maternity pillow 
1 
WO 2008120897 A1 
PCT/KR2008/001712 
10/09/08 
A maternity belt with vibration speaker 
1 
US20130067642 A1 
US 13/239,179 
03/21/13 
Maternity belt structure 
2 
US20130072087 A1 
US 13/239,164 
03/21/13 
Adjustable protective maternity belt 
2 
US 8396229 B2 
US 11/834,085 
03/12/13 
Musical maternity belt  
1 
USD560328 S1 
US 29/261,923 
01/29/08 
Maternity belt  
1 
US3315670 
--- 
04/25/67 
Maternity belt   
1 
US2765470 
--- 
10/09/56 
Maternity belt   
2 
US 20070037483 A1 
US 11/271,892 
02/15/07 
Maternity belt   
1 
US2486211 
--- 
10/25/49 
Maternity belt   
2 
US6537132 B1 
US 09/696,873 
03/25/03 
Maternity brace 
1 
US 20090142988 A1 
US 11/998,477 
06/04/09 
Lower uterine segment maternity support belt  
2 
USD658350 S1 
US 29/370,112 
05/01/12 
Asymmetric maternity support belt 
1 
US 3623488 
--- 
11/30/71 
Belly-band 
2 
Notes: †Subjective scoring: 1=minimal to no similarity → 5=highly similar 
 
 
 

 
 
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Table 2. Positional Therapy for Positional-dependent Obstructive Sleep Apnea (POSA) – Product Search 
 
 
 
Company 
Device(s) 
Description 
Cons 
NightBalance B.V.  
(Delft, The Netherlands) 
NightBalance Sleep 
Position Trainer  
For light and moderate POSAS. Electronic sensor 
worn on an ergonomic strap around the chest. 
Vibrates when in supine position. Comfortable and 
user friendly. Trains user not to sleep supine. Can 
monitor sleep data on computer. 
Expensive. Requires batteries. High-
tech. Only prevents supine sleep. 
Available by prescription only (requires 
sleep examination). 
Advanced Brain 
Monitoring(CA, USA) 
Sleeptech Night Shift 
Sleep Positioner 
For POSAS and snoring. Electronic sensor worn 
around the neck. Vibrates when wearer is supine 
and increases in intensity until wearer shifts. Can 
monitor sleep data on computer. 
Price ($270). Rechargeable battery lasts 
three nights. High-tech. Only prevents 
supine sleep. 
N/A 
Tennis ball technique 
For POSAS. Simple. No electric components. A 
belt or shirt with pockets large enough to put a 
tennis ball inside. Also in the form of a pouch with 
straps. 
Back discomfort. Low compliance long 
term. Only prevents supine sleep. Tennis 
balls can move around or fall out while 
sleeping. 
Zzoma (PA, USA) 
Zzoma Thoracic Anti-
Supine Band   
For POSAS. No electric components. A belt with a 
large piece of foam mounted on the area that 
covers the wearer's back. Prevents the wearer 
from rolling onto back while sleeping. Side elastics 
for comfortable breathing. 
Bulky. Worn around the upper torso. If 
wearer wants to switch from left to right 
side, they must do so via the stomach. 
Only prevents supine sleep. Available by 
prescription only. 

 
 
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Table 3. Pregnancy Sleep Product Search 
 
 
Company 
Device(s) 
Description 
Cons 
Utterly Yours (VA, USA) 
Pregnancy Pillow 
For maternal sleep. Simple, full-length, wedge, or 
U-shaped pillows to support and align the back and 
hips, and support the belly, knees, and/or body to 
help reduce pain and provide a good night sleep. 
Claim to benefit a pregnant mother's comfort, rest, 
and health. 
Expensive. Bulky. Emphasizes comfort, 
not optimal position. Encourages lateral 
sleep, but does not prevent supine sleep 
or lateral-right sleep. 
Boppy (CO, USA) 
Cuddle Pillow, Custom Fit 
Total Body Pillow, 
Pregnancy Wedge 
Leachco (OK, USA) 
Snoogle Total Body Pillow 
Today's Mom (CO, USA) 
Coolmax, Cozy Cuddler, 
Cozy comfort  
Oggi (USA) 
Elevation 
Yaz Design (USA) 
Pillowband 
Peachy Products (South 
Africa) 
Stress Nest 
Motherhood Maternity 
(USA, Canada) 
Tummy Sleeve, Ultimate 
Maternity Belt, Maternity 
Support Belt 
Wide pieces of stretchy fabric in a tube 
configuration designed to discreetly offer back 
support and lower belly support during pregnancy. 
Some have additional suspender-like straps to 
provide further fixation and support. 
Does not affect sleeping position. 
Mama Band (USA) 
Belly Band 
Ingrid & Isabel (CA, 
USA) 
Bellaband, BeBand 
Cabea, LLC (CT, USA) 
BabyBellyBand