Korle Bu Teaching Hospital - Global Innovations for Reproductive Health & Life Healthy Birth Weight Study: A Cross-Section
Conditions: Infant, Small for Gestational Age, Infant, Low Birth Weight, Pregnancy, Sleep, Infant, Very Low Birth Weight, Fetal Growth Retardation
Sponsor: IWK Health Centre

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Cover Page 
 
 
Research Protocol 
 
 
Official Title: Korle Bu Teaching Hospital - Global Innovations for Reproductive Health & Life 
Healthy Birth Weight Study: A Cross-Section 
 
 
NTC03062228 
 
 
Document Date: 20JUL2016 
 
 

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Title:   
 
 
KBTH-GIRHL Healthy Birth Weight Study: A Cross-Section 
 
Principal Investigator: 
Maxfield Okere 
 
 
 
 
Department of Biostatistics 
 
 
 
 
Obstetrics and Gynaecology Department 
 
 
 
 
Korle Bu Teaching Hospital 
 
 
 
 
okeezy@live.co.uk 
 
Co-Investigators: 
 
Dr. Jerry Coleman, MB, ChB, FWACS 
 
 
 
 
Obstetrics and Gynaecology Department 
 
 
 
 
Korle Bu Teaching Hospital 
 
 
 
 
P.O. Box Os 06, Accra, Ghana  
jerryc714@yahoo.com 
 
 
 
 
+233 (206) 301079 
 
 
 
 
 
Allan Kember, B.Sc. Engineering, MD candidate 
 
 
 
 
Global Innovations for Reproductive Health & Life (GIRHL) 
 
 
 
 
221 Walker St., Summerside, PE, Canada, C1N 5N9 
 
 
 
 
kember@girhl.org  
+1-902-580-8385 
 
Jonathan Gale, B.Sc., MD candidate 
Dalhousie Medical School 
1389 Robie St., Halifax, NS, Canada, B3H 3E3 
jonathan.gale@dal.ca 
+1-902-240-8697 
 
 

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Abstract 
Recently, three studies have suggested that maternal back sleep may be a risk factor for 
stillbirth (SB) and low birth weight (LBW). This is significant given that the majority of third-
trimester pregnant women spend up to 25% of their sleep time on their back. The Ghana 
PrenaBelt Trial (GPT), currently underway at the Korle Bu Teaching Hospital (KBTH) and led 
by a member of our team (Dr. Jerry Coleman), is the first interventional trial investigating 
this possible relationship between maternal back sleep and LBW. However, a limitation of 
the GPT is that due to its sham-control design, all participants in the trial (treatment group 
and sham-control group) have been educated during the consent process about back-sleep 
in late pregnancy as a possible risk factor for SB and LBW. At interim analysis of the GPT, no 
difference in birth weight was found between the two groups. The GPT team has had 
anecdotal reports from sham-group participants who indicate that they have trained 
themselves to sleep exclusively on their left side. Further, there is evidence in the literature 
that when instructed to sleep on their left, third-trimester pregnant women can increase 
the percentage of left-sided sleep to approximately 60% of the night on average and 
maintain this across multiple nights. 
 
Given this, it is questioned if the back-sleep education during the consent process 
could be having an effect on the sleep behaviour of the GPT participants independently of 
their treatment allocation; therefore, the aim of this study is to establish a reference birth 
weight of babies born to a cohort of women comparable to the cohort in the GPT but who 
have not received back-sleep education, did not participate in the GPT, and whose babies 
were born in a similar time period and weighed on the same newborn scales – in essence, a 
control group for the GPT. 
 
This cross-sectional study will be accomplished via recruiting a control group from a 
pool of women having recently delivered at KBTH, reviewing their hospital records, and 
having them complete a short questionnaire. 
 
The results of this study, together with the results of the GPT, will enable us to 
determine whether or not education about back-sleep in pregnancy affects pregnancy 
outcomes, specifically birth weight. 
 

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1 Background 
According to the WHO, stillbirth (SB) is defined as fetal death at gestation ≥28 weeks or 
weight ≥1000g (1). Low birth-weight (LBW) is defined as a weight less than 2500g at birth 
(2). LBW is a significant contributor to SB (3), and infants with LBW are 20 times more likely 
to die in the first year than heavier babies (2). Although LBW babies constitute only about 
15% of live births, they account for 60-80% of neonatal deaths (4) (5) (6) (7). Neonatal 
deaths (death within the first 28 days of life) account for 40% of all deaths under the age of 
five years (8). LBW also accounts for significant morbidity such as cognitive impairment (9), 
and chronic diseases later in life (2) (10).  
 
In obstetrics, it is well-known that when a pregnant woman lies on her back during 
the day, maternal cardiovascular parameters (11) (12) (13) and/or fetal oxygenation (14) are 
altered, occasionally causing significant fetal heart rate changes, particularly during labor 
(15). However, until recently, there has been little evidence on the effect of the back 
position during sleep in pregnancy. Recently, three studies, including a 2012 study based in 
Ghana by members of our team (Dr. Jerry Coleman, Dr. Louise O’Brien), have suggested that 
maternal back sleep may be a risk factor for SB (16) (17) (18) and LBW (18). This is significant 
given that the majority of third-trimester pregnant women spend up to 25% of their sleep 
time on their back (19).  
1.1 Relevance & Innovation 
Women in Ghana suffer from one of the highest perinatal mortality rates in the world. 
Every day in Ghana, 47 babies are stillborn (1) and 232 babies are born with LBW (20) – 
many of whom will die in infancy or suffer lifelong consequences. As such, Ghana urgently 
requires inexpensive interventions to reduce perinatal morbidity and mortality – assisting 
pregnant Ghanaian women to avoid sleeping on their back might be one such intervention. 
A maternal positional therapy device, called “PrenaBelt”, has been developed by 
members of our team (Allan Kember, Ali Borazjani) to modify maternal sleep position and 
mitigate this risk factor. The Ghana PrenaBelt Trial (Principal Investigator: Dr. Jerry Coleman; 
Ethics: NMIMR-IRB#069/14-15, IWK-REB#1019318; Regulation: FDA/CT/152, NCT02379728) 
is a sham-controlled, double-blind, randomized trial in N=200 healthy, third-trimester 
pregnant women at the Korle Bu Teaching Hospital Obstetrics and Gynaecology 
Department. The purpose of the Ghana PrenaBelt Trial is to determine the effect of 

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PrenaBelt use during sleep throughout the third trimester on birth weight. Recruitment for 
the Ghana PrenaBelt Trial was 100% complete on 02MAR2016 and data collection was 
completed on 25JUN2016. 
1.2 Rationale 
At the half-way point in the Ghana PrenaBelt Trial (“GPT”) (n=41 births in each group), 
no difference in birth weight was found between the two groups (PrenaBelt versus sham-
PrenaBelt) on a two-sample t-test (p=0.51). Conclusions were the same using a non-
parametric method (Wilcoxon rank sum test). Note that hypothesis for the GPT is that the 
birth weights will be higher in the PrenaBelt group than in the sham-PrenaBelt group.  
The GPT was originally proposed as a randomized controlled trial with a treatment 
(PrenaBelt) group and a control (no PrenaBelt) group; however, the Noguchi-IRB strongly 
recommended that the study be sham-controlled and double blinded. Our team elected to 
follow the IRB’s recommendation. 
In the GPT, participants are educated on the rationale for the study as part of the 
informed consent process, i.e., back sleep in late pregnancy has been recently implicated as 
a possibly modifiable risk factor for stillbirth and low birth weight. Participants are 
subsequently randomized to receive treatment with a PrenaBelt or a sham-PrenaBelt and 
are blinded to their treatment allocation. 
Given the results of the interim analysis, it is questioned if the back-sleep education 
during the consent process could be having an effect on the sleep behaviour of the 
participants independently of their treatment allocation. The GPT Team reports that the 
education could be having an effect, for example, some participants in the sham-PrenaBelt 
group have reported that they stopped using their assigned device because they had since 
trained themselves to sleep exclusively on their left side using alternative means. 
Many campaigns have had unprecedented impact on public health by education alone, 
for example, the “back-to-sleep” campaign to prevent sudden infant death syndrome. 
Therefore, since both the PrenaBelt (treatment) and sham-PrenaBelt (sham-control) groups 
have received back-sleep education, our team contends that an investigation of a third 
group without back-sleep education, a true control group, is warranted for comparison. 

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2 Research Question 
What is the mean birth weight and standard deviation of babies born to a cohort of 
women who: 
• Meet the same inclusion/exclusion criteria as the cohort in the Ghana PrenaBelt 
Trial, 
• Have not received education that back sleep during late pregnancy is a possible 
modifiable risk factor for low birth weight and stillbirth, 
• Did not participate in the Ghana PrenaBelt Trial, and 
• Gave birth to their babies in a similar time period (year 2016) as the Ghana 
PrenaBelt Trial? 
3 Aims 
To establish a reference birth weight (mean and standard deviation) of babies born to a 
cohort of women comparable to the cohort in the Ghana PrenaBelt Trial but who have not 
received back-sleep education, did not participate in the Ghana PrenaBelt Trial, and whose 
babies were born in a similar time period and weighed on the same newborn scales. This 
reference birth weight will serve as a control for the Ghana PrenaBelt Trial. 
3.1 Specific Objectives 
1. Conduct a review of hospital records to confirm the control group participants meet 
the inclusion/exclusion criteria of the Ghana PrenaBelt Trial and record the: 
a. Birth weight 
b. Date of delivery 
c. Mode of delivery 
d. Gestational age at delivery 
2. Administer a questionnaire to collect demographic, obstetric, and sleep habit data 
for characterization of the control group and comparison of the control group to the 
groups (treatment, sham-control) in the Ghana PrenaBelt Trial. 
4 Literature Review 
 
In 2009, the World Health Organization reported the global prevalence of stillbirth (SB) 

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to be 2.6 million (uncertainty range: 2.1-3.8 million), of which 98% occur in low- and middle-
income countries (1) – see Figure 1. 
 
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 low- and middle-income countries with the highest concentrations in 
Asia and Africa (2) – 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 (2). 
 
 
Figure 1. Maps of global stillbirth and low birth weight rates. Data source: World Health Organization, 
2009. 
 
 
In the Auckland Stillbirth Study (17), the population attributable risk (PAR) for non-left 
sleep position to SB was found to be 37%, which is greater than the PARs of the three most 
important modifiable risk factors for SB (obesity, advanced maternal age, and smoking) 
combined (3). In an African population (18), members of our team (Dr. O’Brien, Dr. Coleman) 

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found that back sleep during pregnancy was an independent predictor of LBW (OR, 5.0; 95% 
CI, 1.2–20.2; P=0.025) and SB (OR, 8.0; 95% CI, 1.5–43.2; P=0.016), when controlling for 
covariates maternal age, gestational age, parity, and the presence of pre-eclampsia. Notably, 
LBW was found to mediate the relationship between back sleep and SB (18). In the Sydney 
Stillbirth Study (16), the back sleep position was associated with SB (adjusted OR, 6.26; 95% 
CI, 1.2–34) and the PAR for reported back sleep was 9.88% (95% CI, 5.67-14.1%). Currently, 
there is much interest (21) and follow up research occurring worldwide (22). 
One proposed model for maternal back sleep playing a causative role in low birth 
weight and stillbirth is that back sleep is a “fetal stressor” via compression of the abdominal 
aorta and inferior vena cava (‘aortocaval compression’) when lying on the back, and, when 
combined with “maternal factors” and “placental or fetal vulnerability”, may result in 
negative sequelae. This model is known as the triple-risk model for late unexplained 
stillbirth (23) – see Figure 2. Our team proposes that by mitigating the “fetal stressor”, we 
may protect the fetus from LBW or SB. 
 
Figure 2. Triple Risk Model for Late Unexplained Stillbirth (23). 
 
Some pregnant women sleep with many pillows supporting their body, including a 
pillow behind their back to avoid the supine position. Indeed, we expect that some pregnant 
women in Ghana may increase the amount of time that they spend sleeping on their left side 
as their pregnancy progresses perhaps due to hearing or reading a “sleep on the left in 
pregnancy” or “SOS” (Sleep-On-Side) message, for example, hearing about the Ghana 
PrenaBelt Trial or browsing other resources (24). 

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Our colleague and team member from Australia (Dr. Jane Warland), has recently 
published data (25) relevant to the issue under consideration in this research protocol: 
• Moderate correlation between diary-reported and video-determined 
indicators of sleep position indicates that third-trimester pregnant women are 
reliable when self-reporting their sleep position. 
o Comment: This lends credence to anecdotal reports of participants in 
the sham-control group in the GPT who report that they have trained 
themselves to sleep on their left side. 
• Instructing third-trimester women to sleep on their left side can increase the 
percentage of left-sided sleep to approximately 60% of the night; however, 
this can be highly variable (ranging from 11% to 98%) and may come at a cost 
of a slightly reduced sleep duration for women who do not normally adopt the 
left position, perhaps due to women feeling they need to make a conscious 
effort to maintain the left sleep position. 
o Comment: This lends credence to our hypothesis that back-sleep 
education may be having an independent effect on sleep behavior in 
the GPT regardless of treatment assignment. 
• When third-trimester pregnant women are instructed to sleep on their left, 
the percentage of time spent sleeping on the left side is relatively consistent 
within individuals across multiple nights, with an average difference of only 
15% between nights (maximum 40%). 
o Comment: If participants in the sham-control group in the GPT have 
truly trained themselves to sleep on their left side, this indicates that 
many will be able to consistently maintain the left side position 
throughout the remainder of their pregnancy without the assistance of 
a device. 
5 Methodology 
5.1 Study Design 
This study will be of a cross-sectional design. 

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5.2 Study Site 
This study will be conducted at the Korle Bu Teaching Hospital within the Obstetrics 
and Gynaecology Department (labor wards, Biostatistics Department, Dr. Jerry Coleman’s 
office). The existing KBTH infrastructure (Detecto digital newborn scales installed by GIRHL 
in partnership with KBTH) and existing Ghana PrenaBelt Trial instrumentation (laptop, 
tablet, Surfline, printer, scanner/copier, filing cabinet, stationary – all property of GIRHL) will 
be used for this study. 
5.3 Subjects/Study Population 
The participants (subjects) will be healthy, Ghanaian women who have recently 
delivered a live birth at KBTH. 
The inclusion/exclusion criteria criteria will be similar to the Ghana PrenaBelt Trial 
with one difference and one additional inclusion criterion – see Table 1: 
Table 1: Inclusion/Exclusion Criteria 
Ghana PrenaBelt Trial 
KBTH-GIRHL Healthy Birth Weight Study 
Inclusion Criteria 
≥18 years old 
Same 
Low-risk singleton pregnancy 
Same 
Entering the last trimester of pregnancy (in range 
26-30 weeks of gestation) 
Different: Delivered a live birth >28 weeks 
gestation at KBTH within the past 48 hours. 
Residing in the Greater Accra Metropolitan Area 
or area served by the KBTH 
Same 
Fluent in either English, Twi, or Ga 
Same 
N/A 
Additional: Has not received education/ 
information about back sleep position in 
pregnancy as a potential risk factor for 
stillbirth and low birth weight. 
Exclusion Criteria 
BMI ≥ 35 at booking (first antenatal appointment 
for current pregnancy) 
Same 
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]) 
Same 
Sleep complicated by medical conditions (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]) 
Same 
Multiple pregnancy 
Same 
Known fetal abnormality 
Same 

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Maternal age >35 
Same 
 
5.4 Sample Size Determination 
A sample size of one-hundred sixty-two (N=162) participants is selected for the KBTH-
GIRHL Healthy Birth Weight Study. N=162 is the minimum combined group size for the 
Ghana PrenaBelt Trial: n=81 treatments plus n=81 sham-controls. The Ghana PrenaBelt Trial 
sample size was statistically justified (using power of 0.8 and type I error probability of 0.05 
and accounting for 20% lost to follow up) based on a previous study in a Ghanaian 
population by members of our team (Dr. O’Brien, Dr. Coleman) (18) and using the PS Power 
and Sample Size Program (Version 3.0).  
In order to avoid variance bias in comparison of the non-educated (KBTH-GIRHL Healthy 
Birth Weight Study) group to the back-sleep educated group (Ghana PrenaBelt Trial), the 
group sizes should be the same; therefore, one-hundred sixty-two (N=162) participants will 
be included in this study to match the 162 (minimum) participants in the Ghana PrenaBelt 
Trial. Since this is a cross-sectional study to recruit a control group only, no participants in 
this study will be lost to follow up; therefore, 162 participants are required in this study. 
5.5 Procedures 
 
1. Each participant will be screened, consented, and enrolled per Section 9.4 – Process 
for Seeking Consent.  
2. Each enrolled participant will be assigned a six-digit alpha-numeric code by the study 
personnel. As each new participant is enrolled, the study personnel will construct 
the key to this code, which links the code to the participant’s KBTH hospital record. 
This key will be kept strictly confidential by the study personnel - see Section 9.3 
Minimization of Potential Harms for data security and privacy/confidentiality 
protection measures. All study data will be collected only in association with this 
code, thus automatically de-identifying the data. 
3. The study personnel will complete the Data Collection Questionnaire with each 
participant. Since the questionnaire will be administered on the wards, it is possible 
that the participant’s responses may be overheard by others other than the study 
personnel conducting the questionnaire; therefore, the participant will be informed 

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that she may refuse any question that she feels uncomfortable answering. It is 
expected that the questionnaire will take ten to fifteen minutes to complete. 
4. After the study personnel completes the questionnaire with the participant, the 
study personnel will review the participant’s KBTH hospital record and complete the 
participant’s Delivery Outcomes Form. 
5. For each participant, the study personnel will upload the Data Collection 
Questionnaire and Delivery Outcomes Form data (both documents include de-
identified data only) to the research team’s secure Microsoft OneDrive cloud for 
data extraction in preparation for the data analysis by the research team. 
6 Data Handling 
All study personnel involved in the conduct of this study at the study site (Maxfield 
Okere, Dr. Jerry Coleman) and data handling have received Good Documentation Practice 
(GDP) training as part of the Ghana PrenaBelt Trial within the past two years. Reference 
Section 10 and Section 34 in the Ghana PrenaBelt Trial Site Study Master Record (FDA 
regulatory file) in Dr. Jerry Coleman’s office. Also reference GIRHL-SOP.005 – Guidelines for 
Completing Forms in the Ghana PrenaBelt Trial SOP/SSP Binder in Dr. Jerry Coleman’s office. 
In addition, Dr. Jerry Coleman has completed Good Clinical Practice training with the Ghana 
Food and Drugs Authority in the past two years. 
All study personnel involved in off-site data handling and data quality monitoring (Allan 
Kember, Jonathan Gale) have completed Tri-Council Policy Statement (TCPS-2) training 
within the past two years. In addition, Allan Kember has completed Good Clinical Practice 
(GCP) training for investigators from the Collaborative Institutional Training Initiative (CITI) 
Program within the past two years. 
See Section 9.3 Minimization of Potential Harms for measures in place to ensure data 
security and protect participant privacy and confidentiality. 
7 Statistical Analysis 
Descriptive statistics (mean, median, standard deviation, maximum, minimum) will be 
employed for collected demographic, obstetric, and sleep habits information from the Data 

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Collection Questionnaire and key measurements (e.g., birth weight, gestational age at 
delivery) from the Delivery Outcome Form. 
Interpretation of the results from this study will be conducted in conjunction with 
results from the Ghana PrenaBelt Trial (GPT) as follows:  
• Comparison of groups (back-sleep education, no back-sleep education): 
o 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.  
o For dichotomous and categorical data, we will evaluate for differences using 
Chi-squared, Fisher’s exact test, or McNemar’s test for repeated 
measurements. 
• Note that all analyses will be conducted via the intention-to-treat approach in order 
to provide unbiased comparisons among treatment groups. 
Central quantitative data will be sorted and stored in Microsoft Excel files. Quantitative 
data analysis will be performed in the R statistical software. We will report the number of 
participants with missing data.  
Any deviations from the original statistical plan will be done under the supervision of our 
consultant statistician on the GPT (Mr. Michael Butler, M.Sc. Statistics, MD Candidate 2018) 
and described in full and justified in the final report, as appropriate. 
8 Dissemination of Results 
Since the results of this study will be interpreted and presented in conjunction with the 
results of the Ghana PrenaBelt Trial (GPT), we will follow the dissemination plan of the GPT:  
Per Section 3.5.3. Final Report in the Ghana FDA’s Guidelines for Conducting Clinical Trials 
in Ghana, publication of the GPT results in a scientific journal or other medium for the purpose 
of disseminating the information obtained to stakeholders may be encouraged only after 30 
days of acknowledgement of receipt of the Final Report (1 soft copy, 1 hard copy) by the 
Ghana FDA. After these 30 days, the following shall take effect: 
 

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1. According to Grand Challenges Canada’s (GPT funder) Open Access Policy, we must 
“make available to the public through open access channels the results of the research 
emerging from the Project, or any reports or other publications regarding the Project 
funded by this grant (collectively, the "Materials"), and anticipates that the Materials 
will be published in a treatise, thesis, trade publication or in any other format that is 
available for the interested public as soon as practical, consistent with the need to first 
secure intellectual property rights in a manner that maximizes the benefits to 
developing world interests. Specifically, the Grantee is expected to use good faith 
efforts and work in a collaborative fashion with its subcontractors and funders 
associated with the Project to facilitate broad dissemination and accessibility of the 
Materials in the developing world.” Therefore, we intend to make our results freely 
available on the Canadian International Development Research Centre’s Open Access 
Digital Library and on our websites (www.girhl.org, www.icchange.ca). 
2. For any papers accepted and published in peer-reviewed journals, we shall post a 
Word version of our peer-reviewed, accepted article on our organizational websites 
(www.girhl.org, www.icchange.ca) immediately after publication in print or online. 
The Word document will indicate the article’s citation and a link to the published 
article on journal website. 
In addition to the above dissemination plan, we will freely share our results and the Word 
version of our peer-reviewed, accepted article with the Korle Bu Teaching Hospital. If the 
hospital wishes, they may post the documents on the hospital website. We also intend to 
present our results at various conferences in the fields of sleep medicine, obstetrics, and 
global health. The Korle Bu Teaching Hospital will be acknowledged in all publications and 
presentations. 

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9 Ethical Issues 
9.1 Potential Benefits to Participants and Others 
9.1.1 
Participants 
The opportunity to assist in the advancement of sleep-in-pregnancy knowledge and 
the possibility of benefiting other pregnant women in their community, country, and region 
in the future may be a source of immediate satisfaction to participants. 
9.1.2 
Others 
In Canada, three babies are stillborn every day (≥1000g birthweight or ≥28 weeks 
completed gestation) (1). This is a largely unrecognized national issue yet pales in 
comparison to Ghana, where 47 babies are stillborn every day (1). In addition, every day, 61 
Canadian babies are born with LBW (≤2500g) (26), and 232 Ghanaian babies are born with 
LBW (20) – many of whom will die in infancy or suffer lifelong consequences.  
If maternal back 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 (18) – this translates to the 
potential global aversion of 3.7 million LBW and 676,000 SB annually (1) (2). Since LBW is a 
major contributor to SB (3), morbidity (2) (9) (10), and neonatal mortality (60-80%) (4) (5) 
(6) (7), further benefit may be realized. 
The results of this study will be imperative for interpretation of the results of the 
Ghana PrenaBelt Trial (GPT), which is a study testing a novel approach to reducing the global 
incidence of SB and LBW. Demonstrating that back-sleep education does (or does not) 
improve pregnancy outcomes (e.g., birth weight) will be a valuable contribution to existing 
knowledge and may be a key component to reducing the rates of SB and LBW in Ghana 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) (22). If a public health intervention is advised, 
our studies (Ghana PrenaBelt Trial and KBTH-GIRHL Healthy Birth Weight Study) taken 

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together will be at the forefront of scientific investigation into two possible interventions, 
i.e., back-sleep education and positional therapy. 
9.2 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 (Data Collection Questionnaire) than those risks 
they encounter in their everyday life. 
Since personal health information will be collected from participants, there always 
exists the potential harm should breach of confidentiality inadvertently occur. 
9.3 Minimization of Potential Harms 
Personal health information (PHI) used to identify potential participants will not be 
accessed by anyone other than the KBTH study personnel within their circle of care.  
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 the patients’ KBTH 
hospital record number, will be kept in a secure location away from the de-identified study 
data and destroyed at the earliest possible time after it is no longer needed for study 
purposes, 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 in a locked office with 
limited access and on the secure, password-protected, Microsoft OneDrive cloud, 
respectively. 
For all study activities, all data collected from participants will be protected from 
unauthorized access to safeguard participant privacy and confidentiality in accordance with 
Tri-Council Policy Statement (TCPS 2) and personal information policies at the Korle Bu 
Teaching Hospital. 
Study data will only be exchanged in de-identified form and between study team 
members authorized by the Principal Investigator. 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 

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years, after which it will be destroyed in a secure manner (e.g., incineration and cross-cut 
shredding). 
9.4 Process for Seeking Consent 
1. Ethical Approval and Training: This study requires approval from the Korle Bu 
Teaching Hospital Institutional Review Board (Accra, Ghana). All study personnel will 
be trained to the approved Research Protocol by Mr. Maxfield Okere (Principal 
Investigator). 
2. Recruitment:  
• Study personnel (KBTH staff person) within the circle of care of patients who 
delivered a live baby at the KBTH Obstetrics and Gynaecology Department within 
the past 48 hours will visit the wards to invite patients to join the study. In an 
effort to avoid selection bias, the study personnel will visit the wards daily in the 
morning (before patients are discharged) and 100% of patients will be 
approached and invited to participate in the study – this will occur until the target 
sample size for the study is reached. Patients who are interested in joining the 
study will then be screened by the study personnel using the approved Screening 
Inclusion Form to determine if they meet the inclusion/exclusion criteria for this 
study. Note that only study personnel that are within these patients’ circle of care 
will access their patients’ health records. Researchers on the study team who are 
not within the circle of care will not access the patients’ health records.  
• Patients who meet the inclusion/exclusion criteria will be invited to participate in 
the study by the study personnel within the circle of care. If a patient is interested 
in participating, the study personnel will conduct the consent process using the 
approved Information and Consent Form. 
3. Consent: 
• Potential participants, having  
o met the study inclusion/exclusion criteria, 
o been invited to participate in the study, and 
o shown express interest in participating in the study 
will meet with study personnel to complete the consent process. 

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• In the meeting, the study personnel 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 risks and benefits involved in participating in the study, and  
o 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; her de-identified data up to the point of withdrawal will be 
retained by the study team) 
• The capacity of each potential participant to provide consent will be assessed by 
the study personnel 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: 
a. What is this study about? 
b. Why is this study important? 
c. What will you need to do in this study? 
d. What are the risks to you from being involved in this study? 
e. What are the benefits to you from being involved in this study? 
f. What happens if you choose to not participate today? 
g. What happens if you choose to participate today and then change your mind 
at another time and choose to not participate? 
• The study personnel will give each potential participant an opportunity to ask any 
questions she may have. 
• Voluntary, written (or participant’s thumb print along with the signature of an 
impartial witness if the potential participant is not English literate), informed 
consent will be obtained with the participant’s contact information by the study 
personnel from a potential participant who has demonstrated capacity and 
maintains an interest in enrolling in the study. When the Information and Consent 
Form is signed, the participant will be enrolled in the study and assigned a six-

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digit, alphanumeric code for the purposes of de-identifying all data collected from 
her while enrolled in the study.  
• Authorization or refusal of consent by a potential participant will be accepted by 
the study personnel. 
• The Informed Consent Form is the source documentation of the informed consent 
process. The original, signed, and dated consent will be placed in the secure files 
of the Principal Investigator. 
10 Timeline/Work Schedule 
March-July 2016:  
Obtain ethics approval from KBTH-IRB for the KBTH-GIRHL Healthy 
Birth Weight Study 
July-November 2016:  Conduct the KBTH-GIRHL Healthy Birth Weight Study (chart reviews, 
questionnaires) 
December 2016: 
Analyze data from the KBTH-GIRHL Healthy Birth Weight Study in 
conjunction with data from the Ghana PrenaBelt Trial. 
 
 
Table 2 – Study Personnel 
Name 
Role 
Maxfield Okere 
As Principal Investigator, he will conduct screening of potential participants 
and consent for questionnaire and hospital chart review. He will also 
conduct data capture (via Data Collection Questionnaire and Delivery 
Outcome Form) and storage (via OneDrive cloud). 
Dr. Jerry Coleman 
He will serve as a co-investigator and on-site obstetrician for any questions 
that may arise in relation to the conduct of the study. He will serve as the 
KBTH representative to liaise with the Head of Department and KBTH staff in 
relation to any issues pertaining to the study. 
Allan Kember 
He will serve as a co-investigator and will sponsor the study. He will 
administer the study funds and lead the statistical analysis. He will be the 
GIRHL representative to liaise with collaborating organizations. 
Jonathan Gale 
He will serve as a co-investigator and direct data processing from OneDrive 
storage to analysis in the R statistical package. 
 
11 Budget 
Salary of study personnel:  
 
5000 GHS 
Total: 5000 GHS 

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Note that these funds will be managed by GIRHL, not by the KBTH Administration. Note that 
this budget does not include the KBTH-IRB review fee, which is to be determined and will be 
paid by GIRHL. Note that all instrumentation (including stationary supplies, printing, and 
internet charges) required for the KBTH-GIRHL Healthy Birth Weight Study will be supplied 
by the Ghana PrenaBelt Trial. 
12 Bibliography 
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http://www.who.int/mediacentre/factsheets/fs333/en/. 
8. Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, et al. Global, regional, and 
national causes of child mortality: an updated systematic analysis for 2010 with time 
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Adulthood for Very-Low-Birth-Weight Infants. New England Journal of Medicine. 2002; 
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study in 500 subjects. J Obstet Gynaecol Br Emp. 1960; 67: p. 254. 
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sleep in the third trimester of pregnancy. Acta Obstet Gynecol Scand. 2004; 83: p. 159-
164. 

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15. Thurlow JA, Kinsella SM. Intrauterine resuscitation: active management of fetal 
distress. Int J Obstet Anesth. 2002; 11: p. 105-116. 
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Fetal Growth Restriction, and Late-Pregnancy Stillbirth: The Sydney Stillbirth Study. 
Obstet Gynecol. 2015 January; ePub. 
17. Stacey T, Thompson JMD, Mitchell EM, Ekeroma AJ, Zuccullo JM, McCowan LME. 
Association between maternal sleep practices and risk of late stillbirth: a case-control 
study. 2011; 342. 
18. Owusu JT, Anderson FJ, Coleman J, al. e. Association of maternal sleep practices with 
pre-eclampsia, low birth weight, and stillbirth among Ghanaian women. 2013; 121: p. 
261-5. 
19. O'Brien LM, Warland J. Typical Sleep Positions in Pregnant Women. Early Human 
Development. 2014 March; 90(6): p. 315-317. 
20. The World Bank. The World Bank. [Online].; 2013 [cited 2014 August 31. Available 
from: http://data.worldbank.org/country/ghana. 
21. Chappel LC, Smith G. Should pregnant women sleep on their left? BMJ. 2011; 342: p. 
d3659. 
22. Platts J, Mitchell EA, Stacey T, Martin BL, Roberts D, McCowan L, et al. The Midland and 
North of England Stillbirth Study (MiNESS). BMC Pregnancy & Childbirth. 2014; 14(171). 
23. Warland J, Mitchell EA. A triple risk model for unexplained late stillbirth. 2014; 14(142). 
24. American Pregnancy Association. Sleeping positions during pregnancy. [Online].; 2015 
[cited 2016 March 15. Available from: http://americanpregnancy.org/pregnancy-
health/sleeping-positions-during-pregnancy/. 
25. Warland J, Dorrian J. Accuracy of Self-Reported Sleep Position in Late Pregnancy. PLOS 
ONE. 2014 December; 9(12). 
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[cited 2014 August 30. Available from: http://www4.hrsdc.gc.ca/.3ndic.1t.4r@-
eng.jsp?iid=4. 
 
 
 

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13 Appendices 
13.1 Screening Inclusion Form 
Attached. 
13.2 Information and Consent Form 
Attached. 
13.3 Data Collection Questionnaire 
Attached. 
13.4 Delivery Outcome Form 
Attached. 
13.5 Principal Investigator CV 
Attached.