ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pregnancy,

Thyroid disease,

Iron defeciency

Gestational diabetes

Condition category

Condition code

Public Health

Epidemiology

Metabolic and Endocrine

Thyroid disease

Reproductive Health and Childbirth

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]

Not applicable

Comparator / control treatment

No comparator

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

12 months

Secondary outcome [1]

To determine whether thyroid dysfunction is associated with the high prevalence of iron deficiency anaemia and Diaabetes within this cohort of patients

Timepoint [1]

12 months

Secondary outcome [2]

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]

12 months

Secondary outcome [3]

Moreover, whether a case for universal antenatal screening has to be instituted?

Timepoint [3]

12 months

Secondary outcome [4]

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]

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]

Hospital

Name [1]

Launceston General Hospital

Address [1]

Charles Street
Launceston, Tasmania, 7250 Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Tsamania Human Ethics Committee

Ethics committee address [1]

University of Tasmania
Private Bag 01
Hobart TAS 7001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/07/2011

Approval date [1]

12/08/2011

Ethics approval number [1]

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

Prof Alhossain Khalafallah

Address

Launceston General Hospital
Charles Street
TAS 7250

Country

New Zealand

Phone

+61367776777

Fax

khalafallah@dhhs.tas.gov.au

Contact person for public queries

Name

Alhossain Khalafallah

Address

Launceston General Hospital,
Charles street, Launceston, Tasmania, 7250

Country

Australia

Phone

+61373487111

Fax

+61373487695

khalafallah@dhhs.tas.gov.au

Contact person for scientific queries

Name

Alhossain Khalafallah

Address

Launceston General Hospital,
Charles street, Launceston, Tasmania, 7250

Country

Australia

Phone

+61373487111

Fax

+61373487695

khalafallah@dhhs.tas.gov.au

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

Source	Title	Year of Publication	DOI
Embase	Glycosylated haemoglobin for screening and diagnosis of gestational diabetes mellitus.	2016	https://dx.doi.org/10.1136/bmjopen-2016-011059

N.B. These documents automatically identified may not have been verified by the study sponsor.

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