Arm and Finger Measurement for Blood Pressure Surveillance
Conditions: Hypertension, Pregnancy-Induced
Sponsor: KK Women's and Children's Hospital

Submission Date: 05-Apr-2019  
  
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STUDY PROTOCOL 
 
 
 
 
 
Arm and Finger measurement for Blood Pressure 
Surveillance 
 
 
 
CIRB NUMBER:  
2019/2290 
 
PROTOCOL VERSION: 1.0 
 
PROTOCOL DATE:  
10 May 2019 
 
PRINCIPAL INVESTIGATOR:  
Dr Farida Binte Ithnin, Senior Consultant, KK Women's and Children's 
Hospital (KKH) 
 
 
 
 
 
 
 
 
*Also refer to Section F9 on the statistical analysis details. 
 
 
 
 
 

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Section B : Study Sites, Study Team & Submission Board 
B1. Please select the study sites 
(i) SingHealth and Partner Institutions (PI listed in Section B2(i) should be from any 
of the selected institution(s) under "SingHealth and Partner Institutions".) KK 
Women's and Children's Hospital (KKH) 
B2. Study Team Members 
(i) Add Study Team Members   
 
 
 
 
 
 
 
 
 
B3. Submission Board and other IRB 
(i) Which CIRB is this application being submitted to? 
 CIRB D- Anaesthesia (including acupuncture) 
(ii) Has the study been submitted to another IRB? No 
(iii) Has the application been previously rejected by any IRB? (Including SingHealth 
CIRB) No 
A1. Please enter the Full Protocol Title and Protocol Number (if available) for this Study 
A2. You may assign Protocol Administrators for this study below 
Section A : Protocol Title & Protocol Administrators 
Protocol Title 
: Arm and Finger measurement for Blood Pressure Surveillance 
No. Name 
Institution/Organization 
Department 
Email 
1 
Tan Chin Wen 
KK Women's and Children's 
Hospital (KKH) 
Department of Women's 
Anaesthesiology 
Tan.Chin.Wen@kkh.co m.sg 
2 
Teo Pei Chih 
Agnes 
KK Women's and Children's 
Hospital (KKH) 
Department of Women's 
Anaesthesiology 
Agnes.Teo.PC@kkh.c om.sg 

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Section D: Nature of Research 
D1. Please select one category that best describes your research activities.  
Clinical Research 
D2. Is this a US FDA IND/IDE study or data is intended to be reported to FDA in 
support of an IND/IDE Application? 
No 
 
 vii. Grant Reference Number 
ANAESPRG/02 
 
Does the Principal Investigator or any Study Team Member have any potential conflict of 
interest?  The Declaration is also for the immediate family members of the PI and 
Team Members listed below. 
Section C: Conflict of Interest 
Name 
Study 
Role 
Department 
Institution 
Yes/No 
Dr Ithnin Farida 
Binte 
PI 
Department of Women's 
Anaesthesiology 
KK Women's and Children's Hospital (KKH) 
No 
Dr Cheng Shang- 
Ming 
Co-I 
Department of Women's 
Anaesthesiology 
KK Women's and Children's Hospital (KKH) 
No 
Dr Lim Ming Jian Co-I 
Department of Women's 
Anaesthesiology 
KK Women's and Children's Hospital (KKH) 
No 
Dr Sng Ban Leong 
Co-I 
Department of Women's 
Anaesthesiology 
KK Women's and Children's Hospital (KKH) 
No 
Ms Kee Hwei Min Co-I 
Division of Nursing 
KK Women's and Children's Hospital (KKH) 
No 
E1. Please give information regarding the study's funding source or sponsor information. 
Section E: Study Funding Information 
Grant 
i. Name of Grant Agency: 
SingHealth 
ii. Grant Name: 
ACP 
iii. Amount: 
10000 
iv. Deadline of Grant Application: 
2019 
31 Jan  
v. Has the grant been approved? Yes 
File Name 
Description 
Version 
Number 
Version 
Date 
ANAES ACP Letter of Award - Dr Lim MJ.pdf 
Letter of award 
- 
ACP Letter of Acceptance-(Arm and finger measurement) 
.pdf 
Letter of acceptance_ 
LimMJ 
- 

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E3. Who will be responsible for the payment and compensation of injury or illness to 
participants arising from participation in the study? 
If the patients follow the directions of the Principal Investigator of this research study and are 
injured due to the trial substance or research procedure given under the plan for the research 
study, our institution will provide them with appropriate medical treatment. Payment for 
management of the normally expected consequences of their treatment will not be provided by 
KK Women’s and Children’s Hospital. 
The patients still have all their legal rights.  Nothing said in the informed consent document on 
treatment or compensation in any way alters their rights to recover damages where they can 
prove negligence. 
E4. Who will be responsible for research-related costs? For sponsored studies, 
please list the costs that will be borne by the sponsor. 
SingHealth ACP funding 
Section F: Research Methodology 
F1. Please provide an abstract of your proposed research (Up to 300 words). 
Accurate blood pressure (BP) measurement plays an important role in peripartum care as it is 
essential in detecting hypertensive disorders in pregnancy and medical decision making during 
the pregnancy. The cuff and bladder size have been highlighted as an important factor affecting 
the accuracy of BP measurement. Current international BP measurement recommendations are 
based on mid-arm circumference (MAC) assuming the arm is cylindrical in shape. However, 
evidence have shown a mismatch between these sizes, leading to BP overestimation or 
underestimation in obese patients. This is because the shape of the arm is a truncated cone 
instead of a cylinder, and the cuff will expand irregularly during inflation thus yielding inaccurate 
BP measurements. This is especially evident in Asian pregnant patients whereby no available 
guideline can recommend a suitable cuff for parturients with different MAC. Nexfin is a finger cuff 
device that can be a suitable alternative BP measurement device for such patients. In this study 
we will recruit 300 parturients in third trimester and undergoing nonemergent caesarean section 
in our institution. We will measure their arm and finger sizes, and collect their user experience on 
current practices on BP measurement. The arm measurements will help us identify the proportion 
of women that may require non-standard cuff sizes for BP measurement. It also allows us to derive 
a conicity index and determine whether the MAC, finger measurement or body mass index (BMI) 
is the best clinical predictor. The finger measurements will also help us determine the proportion 
of women that may require non-standard cuff sizes on the Nexfin device for BP measurement. 
The knowledge gathered in this pilot study will be used to design future studies in which we will 
compare the accuracy of Nexfin with standard BP measurement, which in turn will improve BP 
detection, subsequent patient monitoring and satisfaction. 
F2. What are the specific aims and hypothesis of this study? 
The primary hypothesis of this proposed study is the right Mid-Arm Circumference (MAC) is 
correlated with the right arm conicity index (r = 0.4). The specific aims of the study are as below: 
i) In this cohort, to determine the arm conicity index and the association with MAC; 
ii) To obtain arm measurements of parturients of third trimester (>=32wks gestation) to 
determine the proportion of women requiring non- standard BP arm cuff based on their right 
and left MAC; 
iii) To obtain finger measurements of parturients of third trimester to determine the proportion 
of women requiring non- standard BP finger cuff based on the circumference measured at the 
middle phalanx of the right and left middle finger; 
 
iv) To gain user feedback on the experience of current practice of BP measurement according 
to a three-point rating scale. 
F3. Please briefly describe the background to the current study proposal. Critically 
evaluate the existing knowledge and specifically identify the gap that the proposed study 
is intended to fill. 

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Accurate measurement of blood pressure is an important part of peripartum care as it is essential in 
detecting hypertensive disorders in pregnancy and medical decision making during the pregnancy. 
According to the recommendations by the European Society of Hypertension, the cuff and bladder of BP 
device has been highlighted as an important factor in the accuracy of BP measurement. [1] Most 
guidelines recommend a bladder width and length of 40% and 80% of arm circumference respectively 
[1-3], however this may not apply in obese patients. Palatini et al. showed that a mismatch between the 
arm size and the bladder might lead to overestimation or underestimation of up to 30mmHg in obese 
patients [4] and that this overestimation was more significant when standard cuff was used instead of a 
larger cuff [5]. The increase in arm circumference may also contribute to the BP overestimation [5]. 
Another problem with the above recommendation is that it is impractical and costly to manufacture a large 
variety of cuff and bladder sizes for an ideal fit. Several approaches have been suggested, such as 
application of correction factors, having a range of cuffs and having a variety of cuff bladders, but none 
of them is ideal. [1] The recommendation also does not take into consideration the shape of the arm and 
assume it is in a cylindrical form. However, Bonso et al. observed that the arm becomes cone-shaped 
when the circumference of the upper arm is greater than that of the lower arm [6], resulting in a gap 
between the rectangular blood pressure cuff and the surface of the distal part of the arm. [4] When this 
difference becomes too large, a cylindrical cuff will expand irregularly during inflation and yield inaccurate 
BP measurements. This is proven by Palatini et al. in which rectangular cuffs could overestimate BP in 
non-pregnant patients with large conical arms with difference in systolic BP up to 9.7mmHg and diastolic 
BP up to 7.8mmHg. [7] 
The Australasian Society for the Study of Hypertension in Pregnancy has recommended that a standard 
cuff should be used for parturients with arm circumference of £ 33cm, while the large cuff (15x33cm 
bladder) should be used in arm circumference of > 33cm. [8] However, a study by Kho et al. has shown 
that the 33 cm ‘cut-off’ is an arbitrary one, and that hypertension was diagnosed more often with a 
standard cuff in women with an arm circumference < 33cm, as well as in women with arm circumference 
≥ 33cm regardless of cuff size. [9] Our overseas collaborator, Eley et al. has shown that some parturients 
(n=58/450 or 12.9%) might require a large cuff based on their right MAC, and a further six patients (1.3%) 
would need a thigh cuff instead, and that this right MAC is correlated with BMI (r=0.45). This suggested 
that finger cuff may be more suitable for this group of patients, however we have little evidence on 
whether these data are applicable to the Asian parturient population too. [10] Wang et al. did observe 
that there was no MAC difference in adult female when comparing whites and Asians, yet no further data 
was available on comparing the parturients in both groups, and the correlation between BMI and conicity 
index in Asian parturients remains unknown. [11] 
Finger cuff devices such as the Nexfin monitor (BMEYE B.V., Holland) are commonly used for BP 
measurement nowadays. These devices apply the volume-clamp method described by Penaz [12] to 
provide a continuous non-invasive blood pressure reading that avoid the problems of poorly-fitting arm 
cuffs, and hence offer an alternative in women with large or conical arms. However, these patients may 
have peripheral edema and vasodilatation in pregnancy which may lead to poorly fitting finger cuffs and 
inaccuracies in BP measurement. 
With the above background information, we intend to examine the arm and finger sizes of pregnant 
women in our local population in Singapore. These will help us derive a conicity index which will be 
compared to the arm and finger sizes, and BMI to determine which the best clinical predictor is. The finger 
sizes will also provide insights into the proportion of women who require non-standard finger cuffs on the 
Nexfin monitors to determine the suitability of the device for use in our population. Through the knowledge 
gained from this study, we hope to improve the accuracy of BP measurement, change current practices 
to improve detection of hypertensive disorders in pregnancy for early intervention, subsequent patient 
monitoring and improve patient experience during BP measurement. 
 
F4. Please provide a list of relevant references. 

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1. O'Brien, E., et al., European Society of Hypertension recommendations for conventional, 
ambulatory and home blood pressuremeasurement. J Hypertens, 2003. 21(5): p. 821-48. 
2. Pickering, T.G., et al., Recommendations for blood pressure measurement in humans and 
experimental animals: part 1: bloodpressure measurement in humans: a statement for 
professionals from the Subcommittee of Professional and Public Education of the American 
Heart Association Council on High Blood Pressure Research. Circulation, 2005. 111(5): p. 697-
716. 
3. Perloff, D., et al., Human blood pressure determination by sphygmomanometry. Circulation, 
1993. 88(5 Pt 1): p. 2460-70. 
4. Palatini, P. and G. Parati, Blood pressure measurement in very obese patients: a challenging 
problem. J Hypertens, 2011. 29(3): p.425-9. 
5. Fonseca-Reyes, S., et al., Effect of standard cuff on blood pressure readings in patients with 
obese arms. How frequent are arms of a'large circumference'? Blood Press Monit, 2003. 8(3): 
p. 101-6. 
6. Bonso, E., et al., Accuracy of a single rigid conical cuff with standard-size bladder coupled to 
an automatic oscillometric device over awide range of arm circumferences. Hypertens Res, 
2010. 33(11): p. 1186-91. 
7. Palatini, P., et al., Rectangular cuffs may overestimate blood pressure in individuals with large 
conical arms. J Hypertens, 2012. 30(3): p. 530-6. 
8. Brown, M.A., et al., The Classification and Diagnosis of the Hypertensive Disorders of 
Pregnancy: Statement from the InternationalSociety for the Study of Hypertension in Pregnancy 
(ISSHP). Hypertension in Pregnancy, 2001. 20(1): p. ix-xiv. 
9. Kho, C.L., et al., Blood pressure measurement in pregnancy: the effect of arm circumference 
and sphygmomanometer cuff size.Obstet Med, 2009. 2(3): p. 116-20. 
10. Eley, V.A., et al., Arm and finger measurements in the third trimester: Implications for blood 
pressure measurement. PregnancyHypertens, 2018. 14: p. 105-109. 
11. Wang, J., et al., Asians have lower body mass index (BMI) but higher percent body fat than do 
whites: comparisons of anthropometricmeasurements. Am J Clin Nutr, 1994. 60(1): p. 23-8. 
12. Penaz, J., Criteria for set point estimation in the volume clamp method of blood pressure 
measurement. Physiol Res, 1992. 41(1): p.5-10. 
 
F5. Please attach at least two relevant publications that support the conduct of the 
study. 
 
 
 
F6. Please provide an account of the Principal Investigator's preliminary studies and 
progress reports (if any) pertinent to this application. 
Not available. 

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F7. Please state concisely the importance of the research described in this application 
by relating the specific aims to the long term objectives. 
1. 
To identify the most suitable cuff size for BP measurement for parturients of different arm 
and cuff sizes. These data may be presented to hospital administrators for guideline review, which 
in turn improves the BP detection and the subsequent better patient monitoring and satisfaction. 
2. 
To prepare for future cluster and national level grants that will look into broader applications 
during the postpartum period for early identification of those at high risk of hypertension, and 
thereby the appropriate intervention and treatment at earlier time. 
F8. Discuss in detail the experimental design and procedures to be used to accomplish 
the specific aims of the study. If this study involves a retrospective medical record 
review,  
This research is a single-centre pilot study by which a number of 300 parturients will be recruited from 
antenatal clinics in KKH. Caesarean delivery constitutes about 30% total delivery in our institution, 
contributing to 3000-4000 cases annually. There are 9 months for clinical trial recruitment. We will aim 
to recruit at least 34 cases per month (worst case scenario of 13.6% of available patient caseload). We 
have engaged anaesthetists and nursing division that worked on the previous ACP project (EPOC, 
ANAESPRG18/02) working on the same patient population with a more complex protocol and have 
managed to recruit 200 patients within 9 months. Hence, the study is feasible. Written informed consent 
will be obtained. Baseline demographic and obstetric characteristics will be obtained from patient 
medical records during the admission of labour and delivery. Body mass index (BMI) will be calculated 
from patient’s height and weight measured on the day of recruitment. We will collect the below 
measurements using a measuring tape on both arms: 
Measurement 
Description 
Arm length 
The distance between the tip of the acromion process to the tip of the olecranon process on the pos
terior aspect of the arm, with the elbow in the flexed position. 
MAC 
The circumference of the arm at the mid-point of the arm length as measured above, with the arm h
anging by the side. 
Proximal arm 
circumference 
Arm circumference of the arm measured at the axilla, with the arm hanging by the side. 
Distal arm 
circumference 
The circumference at the elbow above the elbow crease, with the arm hanging by the side. 
Finger  
  circumference 
The circumference of the mid-point of the middle phalanx of the middle finger will be measured with 
the hands placed flat on a table. This site is also the recommended site for the Nexfin finger cuff. 
Conicity index 
The conicity index of the arms will be calculated according to Bonso et al. [6] as 100 (proximal arm 
diameter – distal arm diameter)/arm length. 
Appropriate arm cuff size as determined by MAC and finger cuff size as determined by finger 
circumference matched to the manufacturer’s recommendations will be determined by investigators in 
each subject, and the selection will be documented accordingly. Ideally, the upper arm cuff should 
have an inflatable bladder with a length of 80% and a width of at least 40% of the circumference of the 
upper arm. [2] Participants will also respond to a three-point rating scale (Never, sometimes, always) 
about their experience of the procedures for previous BP measurement during the current pregnancy, 
with questions such as the length of time taken to obtain a reading, the need to change a cuff when 
taking BP, the need to take BP on the leg and whether the arm felt uncomfortable when taking BP. 

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F9. Please provide details on sample size and power calculation and the means by 
which data will be analyzed and interpreted (If applicable). 
Sample size calculation: Sample of 300 patients will be adequate to estimate a correlation 
coefficient of 0.4 with 95% confidence interval width as 0.2 i.e. a sample size of 300 produces a two-
sided 95% confidence interval with a width equal to 0.200 when the estimate of Pearson's product-
moment correlation is 0.400. This is based on the correlation results found by investigators at the 
Royal Brisbane and Women’s Hospital in Caucasian population [10]. 
Statistical analysis: For primary hypothesis, we will calculate pearson’s correlation between MAC 
and coincity index with 95% confidence interval for right arm. We will also fit univariate and 
multivariable linear regression between conicity index (outcome variable = Y) and MAC along with 
BMI and weight. Association between coincity index and other variables will be expressed as 
estimate with its 95%CI.  We will also estimate arm and finger measurements of women requiring 
non-standard BP arm cuff with 95%CI based on right and left arm MAC respectively. We will also 
compare difference between right and left arm measurements using paired t – tests. We will also 
estimate finger measurements of women requiring nonstandard BP cuff with 95%CI based on right 
and left middle finger respectively.  We will also compare difference between right and left finger 
measurements using paired t – tests. Patient’s experience on BP measurement will be expressed 
as frequency with proportion. Categorical data will be presented using frequency (percent). 
Continuous variables will be expressed as mean (standard deviation (SD)) or median (interquartile 
range (IQR), range) whichever appropriate. A statistical significant will be set at < 0.05. All the 
analysis will be done using SAS 9.4 software. 
F10. List all activities that are carried out as part of research in this study. Please 
state/list all procedures involved in this research study and attach the data collection 
form (if any) which will be used for CIRB review. 
Patient recruitment with informed consent obtained 
Demographic data collection 
Measurement of arms and fingers 
Cuff Fitting 
 
Questions on previous BP measurement experiences  
Data Collection Form: 
File Name 
Description 
Version Number 
Version Date 
DATA COLLECTION FORM_Armfin SBL.docx 
data collection form 
 
- 
F11. Please describe the participant’s visits (frequency and procedures involved). 
For studies with multiple visits, please attach study schedule. 
One time visit. Once the informed consent is obtained, the arm and finger measurements as well 
as data collection will be done in the same visit. 
F12. Discuss the potential difficulties and limitations of the proposed procedures 
and alternative approaches to achieve the aims. 
Having used a different definition of arm length to calculate conicity, it is not possible to directly 
compare our conicity results with those of Bonso and Palatini [6,7]. This study has not measured 
the accuracy of blood pressure measurements as this may require a longer observation period 
and therefore add on to patients’ inconvenience. Subsequently we are unable to provide an arm 
conicity cut-off, above which finger cuffs may be more suitable. However we have reported the 
frequency of aberrant cuff placement as a surrogate measure of blood pressure measurement 
difficulty. 

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F13. What are the potential risks to participants? 
The potential risks to participants related to the measuring tape and the cuff are that patients may 
be inconvenienced from moving around due to the tape, and also the possible discomfort or poor 
blood circulation if the cuff is used on the same position for an extended period of time.  
NOTES: 
It is not appropriate to provide a nil response as all research procedures have some risks or side effects. For retrospective 
medical records review or questionnaires study, although the risks are expected to be minimal, there may be a potential risk 
from the breach of confidentiality. 
F14. What are the potential benefits (direct as well as indirect) to participants? 
Indirect benefit may refer to the medical knowledge gained in the future, from the 
research. 
There is no direct benefit to the participants. Their participation may contribute to the medical 
knowledge about the effect of arm conicity on the accuracy of BP measurements in obese 
pregnant women and explore the accuracy of alternative devices. 
F15. What is the estimated timeline for this study? 
(i) Estimated start date  01-May-2019 
(ii) Estimated end date  30-Apr-2021 
F16. Does this study have a Study Protocol? 
No 
NOTES:  
Investigators conducting Clinical Trials must submit a Study Protocol for CIRB 
review. You may refer to the CIRB website for the Protocol template (Clinical Trial) 
and Protocol Template (Clinical Research). 
http://research.singhealth.com.sg/pages/centralisedinstitutionalreviewboard.aspx 
F17. The Principal Investigator is responsible for ensuring that all study 
participants give informed consent before enrolling into the study. 
Please select the applicable consent scenarios. Please select “Waiver of Informed 
Consent” if consent has been obtained for research purposes. 
Informed Consent will be taken for all study subjects. 
 
 
Section H: Recruitment Details 
H1. How will potential participants be identified? Please tick all the applicable boxes. 
 
 
 
 
 
 
 
 
 
 
 
 
 

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I1. Please state the target number of research participants to be recruited for each site in 
Singapore.  If exact numbers are not available, please give a number range in the 
recruitment target. 
I2. Is this study part of an international study? 
K1. Please list the inclusion criteria for research participants in this study. 
K2. Please list the exclusion criteria for research participants in this study. 
K3. Please state the age group of the research participants. 
Section I: Study Sites & Recruitment Targets 
No. Study Site 
Total Target 
Adults (Male) Adults (Female) Children 
1 
KKH 
300 
0 
300 
0 
No 
Section K: Research Participant Characteristics 
American Society of Anaesthesiologists physical status 1 or 2 (ASA 1 or 2) parturients at >=32 weeks of gestation 
Multiparous or nulliparous; 
Age 21-50 years old; 
Undergoing Caesarean section in KKH. 
Emergent Caesarean section such that consent and measurements cannot be taken. 

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K7. Does the study involve any vulnerable research participants? Please select 
'Yes' to view the options and select the applicable population(s). Yes 
[x] If Pregnant Women, Foetuses and Neonates is selected, please respond to Section L. 
[  ] If Children is selected, please respond to Section M. 
[  ] If Prisoners is selected, please respond to Section N. 
[  ] If a Cognitively Impaired Persons is selected, please respond to Section O. 
[  ] Others 
K8. Does the study involve any of the following? 
[x] Inpatients. 
[  ] Outpatients. 
[  ] Healthy Volunteers. 
[  ] Not applicable. 
Section L: Research Participants – Pregnant Women, Foetuses & Neonates 
L1. Please indicate if your research involves: 
[x] Pregnant Women and Foetuses. 
[  ] Neonates of Uncertain Viability and/or Nonviable neonates. 
[  ] Nonviable neonates. 
NOTES: 
Please ensure that your research does not involve maintaining the vital functions of 
the neonate artificially or terminating the heartbeat or respiration of the neonate. 
 
L2. Describe if appropriate preclinical studies, including studies on pregnant 
animals and clinical studies including studies on non-pregnant women, have been 
conducted and data is available to assess risks to pregnant women and foetus. 
Our collaborator from Royal Brisbane Women's Hospital/The University of Queensland 
(Victoria Eley) has performed similar studies on pregnant women and reported no adverse 
events in the studies, despite the fact that the recruited patients were from a high-risk tertiary 
obstetric population. 
L3. Describe if the risk to the foetus is the least possible in order to achieve the 
research objectives. 
The arm and finger measurements are of minimal risks to the mothers and pose no risk to the 
foetus. 
L4. Describe the additional safeguards that will be provided to protect the rights, 
safety and welfare of these vulnerable participants. 
The informed consent process will be conducted during recruitment at the antenatal 
clinic/wards before their cesarean delivery. it will take place in a single private room. They will 
be given time and space to make an informed decision with their partner or husband present 
at all times. They will be given verbal as well as written information. With the activation of 
HBRA, informed consent will be obtained in the presence of a prescribed witness. 

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L5. Special Informed Consent Requirements (Check all that apply). 
[x] I will obtain consent from the pregnant women because: 
[x] Research holds out the prospect of direct benefits to the pregnant women. 
[  ] Research holds out the prospect of direct benefits to both the pregnant women 
and the foetus. 
[x] Risk to the foetus is not greater than minimal and the purpose of the research 
is the development of important biomedical knowledge that cannot be obtained 
by any other means. 
[  ] I will also obtain consent from the father because the research holds out the prospect 
of direct benefit solely to the foetus. 
[  ] The Informed Consent document(s) will provide information regarding the 
reasonably foreseeable impact of the research on the foetus or neonate. 
L6. Assurances by Principal Investigator. 
• 
There will be no inducements, monetary or otherwise, offered to terminate a pregnancy. 
• 
Individuals engaged in the research will not have any part in any decisions as to the 
timing, method, or procedures used to terminate a pregnancy. 
• 
Individuals engaged in the research will not have any part in determining the viability of 
a neonate. 
I agree with the above statements. Kindly select response "Yes" or "No". Yes 
Section P: Consent Process – Consent Required 
P1. Describe when the consent process will take place with the potential participant. 
Participants should be approached prior to the initiation of any study procedures and 
should not be approached in a situation where they may feel compromised (e.g. while 
in labour, just prior to a surgical procedure or under sedation). 
With effect from 1 November 2017, for studies regulated under HBRA, please include a 
statement that informed consent will be taken in the presence of a witness (applicable 
to restricted human biomedical research and research that are interventional or 
invasive). 
This study will be advertised on study brochures placed in the antenatal clinics. They will be 
given to all parturients who meet the inclusion criteria during the antenatal period. All patients 
who choose to enrol in the study will be counselled by the investigators about the study 
protocol, both verbally and with the patient 
information sheet. Adequate time will be given for discussion and with the investigators to 
clarify any doubts. The risks and benefits in joining this study will be clarified at recruitment 
prior to written consent. With the activation of HBRA, informed consent will be obtained in the 
presence of a prescribed witness. 
P2. Where will the consent process take place with the potential participant (e.g. in 
room ward, outpatient clinic etc.)? Please justify why the place chosen for the consent 
process is suitable. 
Informed consent will be taken place in the antenatal clinics in a private manner. 
P3. Please describe the consent process as follows: 
i. Explain if adequate time will be given to the participant to consider their 
participation. 
This study will be advertised on study brochures placed in the antenatal clinics. They will 
be given to all parturients who meet the inclusion criteria during the antenatal period. 
Investigators or Clinical Research Coordinators will explain to the patients about the study 

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and patients will be given ample time to read the informed consent form about the study 
before obtaining their consent. 
ii. Please explain if the place where consent will be taken is suitable. This place 
should allow the participants to be comfortable and have the right frame of mind to 
consider participation. Participants will be approached in the antenatal clinics. The 
discussion will be conducted in private manner with the patient. 
iii. Please explain how the person taking consent would minimise the possibility of 
coercion or undue influence. 
Participants will receive a patient information sheet. This will be discussed with them in 
private manner in the antenatal clinics. The subjects are able to withdraw from the study 
at any point. The contact details of the Principal Investigator will be provided in the 
information sheet. Patients are free to withdraw the study at any time (including timing 
after their delivery), should they decide not to participate. 
P4. Does your study involve potential vulnerable participants whereby obtaining 
informed consent from the participant is not possible and informed consent is 
required from a Legal Representative (LR)? 
No 
P5. Please describe the provisions to protect the "privacy interest" of the participants 
(e.g. 
consent will be obtained in a separate room, free from intrusion and participants 
are comfortable with the proposed settings). 
Research personnel will conduct all the discussions about the study and answer any 
question in private manner. 
P6. Will consent be documented in the form of a written and signed Research 
Participant Information Sheet and Consent Form? 
Yes 
 
File Name 
Description 
Version Number 
Version Date 
 ArmFin PIS - Ver 1 edit Clean.docx 
ArmFin PIS Clean Ver 1 
- 
 ArmFin PIS - Ver 1 edit.docx 
Arm Fin tracked change ver 1 
- 
P7. Will research participants receive any monetary payments (including 
transportation allowances) or gifts for their participation in the study? 
Yes 
The participants will be reimbursed $10 for their time of participation. 
P8. Besides the Informed Consent Form, will any other materials or documents 
be used to explain the study to potential Research Participants (e.g. scripts, 
hand outs, brochures, videos, logs etc.)? 
 
No 
P9. Will the study enrol non-English speaking participants? 
No 

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P10. Will the study be recruiting participants under emergency situations, when 
prior consent of the participant is not possible, and the consent of the 
participant's legal representative, if present, should be requested? 
No 
P11. Do you have any additional comments regarding the Informed Consent process? 
No 
Section R: Research Data Confidentiality 
R1. Will coded/anonymous research data be sent to the study sponsor (e.g. 
pharmaceutical sponsored studies)? 
No, the study team would store all research data within the institution. 
i. Please state where the research data (soft copy and/or hardcopy) will be stored 
and indicate if the location storage is secured (i.e Password Protected PC or Laptop, 
data stored in physical location with lock and key access.) 
The soft copy of research data will be stored in a password protected PC. Hard copies of 
data collection forms are kept by the Principal Investigator under lock and key. The data 
is accessible only by Investigators for analysis purposes only. 
ii. Who will have access to the research data, and how will access to the research 
data be controlled and monitored? (Please state the personnel who will have access 
to the study data eg. 
Principal Investigator, Co-Investigator, study coordinator.) 
Password protected accounts will be created for relevant study personnel and the degree 
of database access granted to the each relevant study personnel (Principal Investigator, 
Co-Investigator and Clinical Research Coordinator) account will correspond to their trial 
responsibilities. The research data will be locked and soft copy will be under the computer 
security of Singhealth. 
iii. Are there any other measures in place to protect the confidentiality of the research 
data? No names or identification number that will identify subjects will be ensured. The 
subjects are only identified by study number. 
iv. Are there any research data sharing agreements with individuals or entities 
outside the Institution, to release and share research data collected? 
No 
v. Describe what will happen to the research data when the study is completed. 
The research data will be kept under lock and key and using computer security of 
Singhealth. The data will be destroyed after keeping for 7 years upon completion of the 
study. 
R2. Will any part of the study procedures be recorded on audiotape, film/video, or 
other electronic medium? 
No 
Section S: Biological Materials Usage & Storage 
S1. Will any biological materials (such as blood or tissue) be used in the study? This 
includes both prospectively collected and existing biological material. 
No 
 
 
 
 
 
 
Section T: Data & Safety Monitoring 

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T1. The purpose of the Data and Safety Monitoring Plan is to ensure the safety and 
well-being of participants, and the integrity of the data collected for the study. 
Depending on the type and risk level of the study, this may include the Principal 
Investigator, experts within the department or institution, independent consultants 
or a combination of the said persons. 
Who will perform the data and safety monitoring? 
The data is kept by the principal investigator under lock and key and using computer security 
of SingHealth. 
The data is accessible only by the investigators for analysis purposes only. The plan for 
adverse effect monitoring would include reporting to CIRB. 
If the DSMB/DMC is an external committee, please include information/details of the 
composition of the external DSMB/ DMC. Kindly attach relevant file(s). 
T2. Please describe the frequency of review (e.g. daily, weekly, quarterly) and what data 
(e.g. adverse events/serious adverse events) will be monitored for safety. 
Safety data is monitored at all times by the investigators. There will be monthly meeting to 
review the study. 
  Adverse events and serious adverse events will be reported to CIRB accordingly. 
T3. How is data integrity monitored to ensure that study data is authentic, accurate 
and complete, and if the data correlates with the case report forms? 
Data is extracted from data collection forms and random audits will be performed to make 
sure it is authentic, accurate and complete. 
T4. Please describe the stopping criteria for the research study based on efficacy, 
futility and safety criteria. 
The stopping criteria for the research study will be based on safety criteria. The review of 
serious adverse effects will be performed. 
T5. Please state the route of dissemination of any data and safety information to 
the study sites, as well as the person/team responsible for doing so. 
Face-to-face communication and email correspondence. 
 
 
 
 
 
Section U: Declaration of Principal Investigator 
Other Attachments 
Note: Please attach only documents that are not relevant to the above sections. 
File Name 
Description 
Version Number 
Version Date 
ArmFin PDPA.pdf 
Armfin PDPA 
- 

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Declaration of Principal Investigator 
This is the Principal Investigator's Declaration. 
I will not initiate this study until I receive approval notification from CIRB and regulatory authority 
approval (if applicable). 
I will not initiate any change in the protocol without prior written approval from CIRB, except 
when it is necessary to reduce or eliminate any immediate risks to the Study Participant. 
Thereafter, I will submit the proposed amendment to the CIRB and other relevant authority for 
approval. 
 
I will promptly report any unexpected or serious adverse events, unanticipated problems or 
incidents that occur in the course of this study. 
I will maintain all relevant documents and recognize that the CIRB staff and regulatory authorities 
may inspect these records. 
I understand that failure to comply with all applicable regulations, institutional and CIRB policies 
and requirements may result in the suspension or termination of this study. 
I declare that there are no existing or potential conflicts of interest for any of the study team 
members participating in this research study and their immediate family members. If there are, I 
have declared them in the relevant section of this application form. 
Site 
Principal 
Investigator 
Study 
Role 
Email 
Declaration Date 
KK Women's and Children's 
Hospital (KKH) 
Dr Ithnin Farida 
Binte 
PI 
Farida.ithnin@kkh.com.s 
g 
Yes 
28-Mar- 
2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Endorsements Page 
KK Women's and Children's Hospital (KKH) 

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Stage 
Name 
Role 
Endorsement Status 
Date 
Department 
A/Prof Ong Chiou Li 
DR 
Endorsed 
29-Mar-2019 
Department Representative Endorsement 
1. Significance: 
Does the study address an important problem? Will the study affect concepts and methods that 
drive the field?  
Yes 
2. Approach: 
Is the conceptual framework adequately developed? Are the design, methods and 
analyses adequately developed and appropriate? Yes 
3. Innovation: 
Does the study challenge existing paradigms? Does it employ novel concepts, approaches 
and methods?  
No 
4. Principal Investigator: 
Is the Principal Investigator appropriately trained to conduct this study? Does the Principal 
Investigator have evidence of commitment (e.g. previous track record)? Yes 
5. Environment: 
Is the Principal Investigator’s environment suited to conduct the study? Is there an adequate 
patient pool and are there adequate resources? Yes 
6. Budget: 
Are the projected costs appropriate (i.e. accurate)? Is the overall budget reasonable for 
the significance of the study? Yes 
7. Time: 
Does the Principal Investigator have adequate resources and time to conduct and 
complete the study? Yes 
Comments: 
Important study to obtain data for Asian patients. 
[x] I acknowledge that this research is in keeping with standards set by the Principal 
Investigator’s Department. 
 Date: 
 29-Mar-2019 
 Full Name: 
A/Prof Ong Chiou Li 
 Department: Division of Clinical Support Services 
  Institution: KK Women's and Children's Hospital (KKH) 
 Endorsement Status : Endorsed 
 
 

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Stage 
Name 
Role 
Endorsement Status 
Date 
Institution 
Dr Chan Wei Shih 
Derrick 
IR 
Endorsed 
29-Mar-2019 
Institution Representative Endorsement 
The Institution Representative has been determined by your institution as the authority that 
declares whether your research is in keeping with the institution’s research objectives, 
reputation and standards. The role of the Institution Representative is not to evaluate the 
scientific or ethical aspects of your study, although they may offer their comments. 
Comments: 
[x] I acknowledge that this research is in keeping with standards set by my Institution. 
Date: 
29-Mar-2019 
Full Name: 
Dr Chan Wei Shih Derrick 
Department: 
Department of Paediatrics 
Institution: 
KK Women's and Children's Hospital (KKH) 
Endorsement Status : Endorsed