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Trial registered on ANZCTR
Registration number
ACTRN12614000273684
Ethics application status
Approved
Date submitted
4/03/2014
Date registered
14/03/2014
Date last updated
14/03/2014
Type of registration
Retrospectively registered
Titles & IDs
Public title
Normal range for haemoglobin A1c (HbA1c), fructosamine and fasting blood glucose in different trimester of pregnancy in non-diabetic Hong Kong pregnant population
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Scientific title
To determine the trimester-specific reference intervals for haemoglobin A1c (HbA1c), fructosamine and fasting blood glucose in non-diabetic Hong Kong pregnant population
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Secondary ID [1]
284193
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gestational diabetes mellitus
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Condition category
Condition code
Metabolic and Endocrine
291648
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0
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Diabetes
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Reproductive Health and Childbirth
291691
291691
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0
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Normal pregnancy
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Reproductive Health and Childbirth
291692
291692
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0
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Antenatal care
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
To determine the trimester-specific reference intervals for HbA1c, fructosamine and fasting glucose in non-diabetic pregnant women, serum samples will be collected once per trimester.
In order to minimize inconvenience to subjects, serum sample collection in first trimester will be done at the time of first trimester Down screening. Serum sample collection in second trimester will be done at the time of oral glucose tolerance test. Serum sample collection in third trimester will be done at 34 – 37 weeks gestation during antenatal visit, together with serum sample collection for other purpose if possible.
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Intervention code [1]
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Not applicable
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Comparator / control treatment
Those diagnosed with gestational diabetes mellitus in this study were compared with those without gestational diabetes mellitus
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Control group
Active
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Outcomes
Primary outcome [1]
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Reference interval for HbA1c by serum assay
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Assessment method [1]
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Timepoint [1]
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In first, second and third trimester
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Primary outcome [2]
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Reference interval for fructosamine by serum assay
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Assessment method [2]
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Timepoint [2]
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In first, second and third trimester
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Primary outcome [3]
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Reference interval for fasting glucose by serum assay
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Assessment method [3]
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Timepoint [3]
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In first, second and third trimester
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Secondary outcome [1]
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Prevalence of gestational diabetes mellitus using the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria
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Assessment method [1]
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Timepoint [1]
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After all deliveries in the study subjects
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Secondary outcome [2]
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Birth weight > 90th percentile in patients with gestational diabetes mellitus diagnosed using IADPSG criteria
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Assessment method [2]
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Timepoint [2]
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At birth in all the study subjects
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Secondary outcome [3]
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Primary Caesarean section delivery in patients with gestational diabetes mellitus diagnosed using IADPSG criteria
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Assessment method [3]
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Timepoint [3]
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At delivery in all the study subjects
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Secondary outcome [4]
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Pre-eclampsia in patients with gestational diabetes mellitus diagnosed using IADPSG criteria,
Pre-eclampsia defined as new onset hypertension and significant proteinuria after 20 weeks gestation
Hypertension defined as systolic blood pressure of over 140mmHg or diastolic pressure of over 90mmHg in 2 measurements at least 4 hours apart
Significant proteinuria defined as urine dipstick of >= 1+, urine protein: creatinine ratio > 30mg/mmol, or 24 hour urine total protein of 300mg/day
Retrospective review of hospital records will be performed
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Assessment method [4]
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Timepoint [4]
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Retrospective review of hospital records will be performed for all study subjects to identify pre-eclampsia during antenatal, intrapartum and postnatal period
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Secondary outcome [5]
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Preterm delivery (< 37 weeks gestation) in patients with gestational diabetes mellitus diagnosed using IADPSG criteria
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Assessment method [5]
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Timepoint [5]
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At delivery in all the study subjects
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Secondary outcome [6]
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Shoulder dystocia (when additional obstetric manoeuvres are required to deliver the fetus after the head has delivered and gentle traction has failed, as documented in the hospital record) in patients with gestational diabetes mellitus diagnosed using IADPSG criteria
Retrospective review of hospital records will be performed
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Assessment method [6]
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Timepoint [6]
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At delivery in all the study subjects
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Secondary outcome [7]
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Birth trauma (third and fourth degree tear) in patients with gestational diabetes mellitus diagnosed using IADPSG criteria
Retrospective review of hospital records will be performed
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Assessment method [7]
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Timepoint [7]
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At delivery in all the study subjects
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Eligibility
Key inclusion criteria
Non-diabetic pregnant women who attend the first trimester Down screening (at 11 to 13+6 weeks gestation) in Queen Elizabeth Hospital, Hong Kong
Patients who signed written informed consent in Chinese or English version
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Patient with pre-existing diabetes mellitus
Patient refusal
Inability of patient to give informed consent
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Convenience sample
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Timing
Both
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Statistical methods / analysis
For estimation a reference range, 200 samples are required(1). For the analysis of prevalence of gestational diabetes mellitus using IADPSG criteria, it is expected the prevalence will be about 33% (2). Assuming a confidence interval of 95% and precision of +/- 5%, the sample size required is 339 subjects (3). To account for possible default and missing data, sample size of 400 subjects is chosen.
Independent paired t-test and chi-squares will be used to analyze the parametric and non-parametric data respectively. Non-parametric method will be used to determine the reference intervals, which does not assume a Gaussian type distribution. The lower and upper reference limits were estimated at the 2.5th and the 97.5th percentiles respectively. SPSS version 17.0 will be used for statistical analysis.
Reference:
(1) Lott JA, Mitchell LC, Moeschberger ML et al. Estimation of reference ranges: how many subjects are needed? Clin Chem. 1992 May;38(5):648-50.
(2) Landon MB, Gabbe SG. Gestational diabetes mellitus. Obstet Gynecol. 2011 Dec;118(6):1379-93.
(3) Kish, L., 1965. Survey Sampling. John Wiley and Sons Inc., New York. ISBN: 047148900X.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/02/2014
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Actual
15/02/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
400
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Hong Kong
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State/province [1]
5861
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Queen Elizabeth Hospital
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Address [1]
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30 Gascoigne Road, Kowloon, Hong Kong
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Country [1]
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Hong Kong
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Primary sponsor type
Individual
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Name
Dr Lee Hui Ling Helena
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Address
H10, Queen Elizabeth Hospital
30 Gascoigne Road, Kowloon, Hong Kong
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Country
Hong Kong
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Department of Obstetrics and Gynaecology,
Queen Elizabeth Hospital
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Address [1]
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H10, Queen Elizabeth Hospital
30 Gascoigne Road, Kowloon, Hong Kong
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Country [1]
287517
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Hong Kong
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Research Ethics Committee (Kowloon Central / Kowloon East)
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Ethics committee address [1]
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Room 808, Block S
Queen Elizabeth Hospital
30 Gascoigne Road
Kowloon
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Ethics committee country [1]
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Hong Kong
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Date submitted for ethics approval [1]
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11/06/2013
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Approval date [1]
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25/09/2013
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Ethics approval number [1]
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KC/KE-13-0138/ER-3
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Summary
Brief summary
The increased risk of adverse pregnancy outcome is related to glycaemic control, which can be monitored by glycated haemoglobin (HbA1c). HbA1c can identify the average blood glucose concentration over the previous months prior to the measurement. The correlation between HbA1c levels and clinical outcomes depends on appropriately-defined reference intervals, which have not been defined in Hong Kong pregnant women. Fructosamine can also be useful in monitoring the effectiveness of therapy in diabetes, in a manner analogous to the HbA1c. It reflects the glycaemic control over the past 2 – 3 weeks. Therefore it can determine the effectiveness of gestational diabetes mellitus (GDM) treatment earlier compare with HbA1c, which may improve pregnancy outcome in patients with GDM. However, there is only limited experience in use of fructosamine in patients with GDM.
Therefore, there is a need to establish trimester-specific reference intervals of HbA1c, fructosamine and fasting blood glucose in non-diabetic pregnant women in the local population, which may be useful in guiding treatment for GDM and diabetes mellitus in pregnancy.
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Trial website
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Trial related presentations / publications
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Public notes
The aim of the study is to establish the normal range for the studied population before applying the tests in management of gestational diabetes mellitus in pregnancy. Those found to have gestational diabetes mellitus will be analyzed for the secondary outcomes.
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Contacts
Principal investigator
Name
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Dr Lee Hui Ling Helena
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Address
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H10, Queen Elizabeth Hospital
30 Gascoigne Road,
Kowloon,
Hong Kong
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Country
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Hong Kong
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Phone
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+852-29582235
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Lee Hui Ling Helena
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Address
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H10, Queen Elizabeth Hospital
30 Gascoigne Road,
Kowloon,
Hong Kong
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Country
46667
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Hong Kong
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Phone
46667
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+852-29582235
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Fax
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Email
46667
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[email protected]
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Contact person for scientific queries
Name
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Dr Lee Hui Ling Helena
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Address
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H10, Queen Elizabeth Hospital
30 Gascoigne Road,
Kowloon,
Hong Kong
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Country
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Hong Kong
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Phone
46668
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+852-29582235
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Fax
46668
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Email
46668
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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