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Trial registered on ANZCTR


Registration number
ACTRN12611000739910
Ethics application status
Approved
Date submitted
13/07/2011
Date registered
14/07/2011
Date last updated
8/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical study to determine the prevalence of thyroid disease in association with iron deficiency and diabetes among Tasmanian pregnant women
Scientific title
A clinical study to determine the prevalence of thyroid disease in association with iron deficiency and diabetes among Tasmanian pregnant women
Secondary ID [1] 262624 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy, 268321 0
Thyroid disease, 268326 0
Iron defeciency 268327 0
Gestational diabetes 287618 0
Condition category
Condition code
Public Health 268452 268452 0 0
Epidemiology
Metabolic and Endocrine 268459 268459 0 0
Thyroid disease
Reproductive Health and Childbirth 268460 268460 0 0
Normal pregnancy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This prospective observational non-controlled study has been conducted at the Launceston General Hospital (LGH). The trial offered to pregnant women who attend for routine antenatal care at the LGH. Patients will be followed up for a period of 6 months. Upon consent, participants are given path forms (TSH, FT3, FT4, TPO, Urine Iodine, Iron Studies and HbA1c) and advised to present in the Pathology around 26 weeks of gestation. TPO antibodies are preferred as they yield best diagnostic score, being positive in 70-80% of women with autoimmune thyroid disease. Iron studies and a full blood count would also be performed to test for the presence of concomitant iron deficiency anaemia. In addition a detailed questionnaire will be administered to these women to identify women that would have been candidates for thyroid testing based on history and symptoms alone. Serum and urine samples once collected and analysed would be stored frozen for a 5 years period of time. Similarly neonatal blood samples in the form of cord blood will also be collected as part of the study from the participants and will be tested for the same parameters and stored for future reference.

OGTT is performed according to our standard protocol. The patient is required to have been in good health for two weeks and to be consuming a normal diet, particularly with regard to carbohydrate intake (>150g/day). The test is performed after an overnight fast of 10 hours. The test is commenced before 10am and the patient remains resting quietly for the duration of the OGTT. Blood samples are collected into Becton Dickinson 2mL Fluoride Oxalate Vacutainer tubes. A sample is collected at baseline and then the patient consumes the 75g glucose load. We use a commercially available product containing 75g of dextrose in 300mL carbonated liquid (SteriHealth Gluco Scan 75g). The patient is required to consume the whole volume within five minutes of commencing the drink. Further blood samples are collected at one hour and two hours post commencement of the dextrose drink. Glucose was measured within three hours of collection of the sample using the Abbott glucose hexokinase method on an Architect C8000 analyser (Abbott Australasia Pty. Ltd.).
HbA1c samples were collected into Becton Dickinson 4mL K2EDTA Vacutainer tubes.
HbA1c was measured by immunoassay using the DCA 2000 (Siemens Ltd., Marburg, Germany). The DCA 2000 analyser measures HbA1c standardised to the National Glycohemoglobin Standardization Program (NGSP), which is in turn aligned to the Diabetes Control and Complications Trial (DCCT) results with international standardisation as set by the International Federation of Clinical Chemistry (IFCC) (http://www.ngsp.org/certified.asp).
Intervention code [1] 266972 0
Not applicable
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269210 0
To determine the actual incidence of thyroid disease within the northern Tasmanian obstetric population serviced by the Launceston General Hospital. This will be measured by spesific thyroid function blood tests and also by urine analysis as well as cord blood testing.
Timepoint [1] 269210 0
12 months
Secondary outcome [1] 279128 0
To determine whether thyroid dysfunction is associated with the high prevalence of iron deficiency anaemia and Diaabetes within this cohort of patients
Timepoint [1] 279128 0
12 months
Secondary outcome [2] 279135 0
To determine whether selective case based screening for thyroid disease is adequate to identify the same number of affected individuals, as would routine screening.
Timepoint [2] 279135 0
12 months
Secondary outcome [3] 279136 0
Moreover, whether a case for universal antenatal screening has to be instituted?
Timepoint [3] 279136 0
12 months
Secondary outcome [4] 321588 0
A direct comparison of HbA1c levels with results of the OGTT in gravid women tested concurrently to assess utility of HbA1c as screening test for GDM.
Timepoint [4] 321588 0
24-28 weeks of gestation

Eligibility
Key inclusion criteria
Gravid women, 18 years of age and above who are in their 1st or 2nd trimester of gestation.
Participation in the study would be offered to the first 500 women presenting for their initial antenatal appointment (“booking-in” visit) at the Launceston General Hospital, Queen Victoria Outpatient department (QVOP) (antenatal clinic).
Women would be recruited for the study upon giving their consent to be tested for thyroid disease, iron deficiency anaemia and to have tissue stored for future testing .
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
patients below 18 year old and women with known pre-existing thyroid disease would be excluded

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2011
Actual
16/04/2012
Date of last participant enrolment
Anticipated
Actual
2/07/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
560
Accrual to date
Final
636
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 267443 0
Hospital
Name [1] 267443 0
Launceston General Hospital
Country [1] 267443 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Clifford Craig Medical Trust Fund
Address
Level, 5,
Launceston General Hospital
Charles Street
Launceston, 7250 Tasmania, Australia
Country
Australia
Secondary sponsor category [1] 266488 0
None
Name [1] 266488 0
Address [1] 266488 0
Country [1] 266488 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269413 0
Tsamania Human Ethics Committee
Ethics committee address [1] 269413 0
University of Tasmania
Private Bag 01
Hobart TAS 7001
Ethics committee country [1] 269413 0
Australia
Date submitted for ethics approval [1] 269413 0
25/07/2011
Approval date [1] 269413 0
12/08/2011
Ethics approval number [1] 269413 0
H0011759

Summary
Brief summary
Current practice at LGH and generally in Tasmania is selective case based antenatal testing for thyroid disease. This is often conducted in a very ad hoc manner and the actual current incidence and prevalence of thyroid disease within the pregnant population is not yet known.
Many professional bodies advocate testing for thyroid dysfunction in pregnancy only if symptoms exist, in the setting of prior personal or family history or in the presence of an antecedent or associated medical condition.
Iron deficiency has been shown to have a negative impact on maternal thyroid function, which is compounded in areas of borderline iodine deficiency. Serum ferritin, transferrin receptor and body iron stores all significant predictors of TSH.
A joint statement by the American Thyroid Association, the American Association of Clinical Endocrinologists and the Endocrine Society in 2005 made firm recommendations for universal screening for thyroid dysfunction in pregnancy as soon as pregnancy is diagnosed.5 Guidelines on management of thyroid disorders during pregnancy published by LeBeau et al in 2006 is in further support of this.
The trial will be offered to pregnant women during their attendance at the antenatl clinic at the LGH. The midwives will assist in the study by conducting the questionnaire and organizing blood tests and consenting participants during the booked visits.
Obstetric, medical, family, social history along with demographic, and perinatal information would entered into the Obstetrix Database as per routine. A further questionnaire addressing detailed thyroid history will be administered. The questions have been derived and modified from Abalovich et al and their recommended approach for case finding. Recruits will then be referred to the Pathology service at the LGH to have their blood and urine taken. Each recruit should have phlebotomy at the same time each day, i.e 8-10 am to eliminate diurnal variations. Fasting serum/plasma collected would be tested for TSH, FT4, FT3, TPO antibodies, FBC, Fe studies also by the Launceston General Hospital pathology service when usually present for 26 weeks Oral Glucose Tolerance Test (OGTT). TSH, FT3, FT4 & Ferritin (part of Fe studies) to be assayed using Ortho Clinical Diagnostics ECI. The Beckman Coulter LH500 analyzer to be used for the FBC, and iron studies to be performed using an Abbott C8000 analyzer. Remaining serum will be divided into 5 aliquots of 1-2ml each and stored frozen at -70 degree for future reference.

Furthermore, we assessed of the utility of HbA1c when used as a screening tool in pregnancy. A direct comparison of HbA1c levels with results of the OGTT test in targeted gravid women, tested concurrently at the 24-28 gestational week and was undertaken in a subset of 480 pregnant women. This amendment was approved the Ethics committee. An informed consent was obtained from all women.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32873 0
Prof Alhossain Khalafallah
Address 32873 0
Launceston General Hospital
Charles Street
TAS 7250
Country 32873 0
New Zealand
Phone 32873 0
+61367776777
Fax 32873 0
Email 32873 0
[email protected]
Contact person for public queries
Name 16120 0
Alhossain Khalafallah
Address 16120 0
Launceston General Hospital,
Charles street, Launceston, Tasmania, 7250
Country 16120 0
Australia
Phone 16120 0
+61373487111
Fax 16120 0
+61373487695
Email 16120 0
[email protected]
Contact person for scientific queries
Name 7048 0
Alhossain Khalafallah
Address 7048 0
Launceston General Hospital,
Charles street, Launceston, Tasmania, 7250
Country 7048 0
Australia
Phone 7048 0
+61373487111
Fax 7048 0
+61373487695
Email 7048 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseGlycosylated haemoglobin for screening and diagnosis of gestational diabetes mellitus.2016https://dx.doi.org/10.1136/bmjopen-2016-011059
N.B. These documents automatically identified may not have been verified by the study sponsor.