HbA1c Study
Research type
Research Study
Full title
Can HbA1c be used to diagnose Gestational Diabetes Mellitus?
IRAS ID
138013
Contact name
Graham Lawson
Contact email
Sponsor organisation
East Sussex Hospitals NHS Trust
Research summary
Gestational Diabetes Mellitus (GDM) is defined as the first sign of Diabetes Mellitus (DM) in pregnancy. The prevalence of GDM is increasing in UK and the current incidence is 2-8% due to obesity¸ lack of physical activity, pregnancies at older age and ethnic population. GDM is associated with high risk complications such as a large baby,low glucose in the baby, still birth, caesarean section and hypertension.
Currently, GDM is diagnosed by the Oral Glucose Tolerance Test (OGTT) which is offered at 24 to 28 week to all pregnant women with high risk factors.
The OGTT is the current test for diagnosing DM which is also used to diagnose GDM based on World Health Organisation (WHO) 1999 guidelines. However in 2011, WHO recommended the use of Glycated Haemoglobin A1c (HbA1c) test for diagnosis of DM but did not include GDM.
The OGTT is inconvenient, time-consuming, requires fasting overnight (8-12 hrs), unpalatable, expensive with poor reproducibility. However HbA1c is a single non-fasting test that can be taken anytime and anywhere. It is already in use for screening, diagnosis and management of non-pregnant DM patients.
Could a single, non fasting measure of HbA1c be used for the diagnosis of GDM? In this study I would like to evaluate the usefulness of HbA1c diagnosis of GDM. This study is laboratory based and involves method comparison of both the tests HbA1c and the OGTT by statistical analysis of their laboratory results on the same blood sample.
Early screening, diagnosis and management of GDM would protect pregnant women and babies from the risk complications. A simple test like HbA1c would make the diagnosis of GDM convenient for the pregnant women and less expensive for the healthcare Trusts.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
14/YH/0104
Date of REC Opinion
26 Mar 2014
REC opinion
Favourable Opinion