Covid-19 GestTesting Study [COVID-19]
Research type
Research Study
Full title
Gestational diabetes during the Covid-19 pandemic: an observational study \nto critically evaluate and refine the novel diagnostic strategy for gestational diabetes\n
IRAS ID
282553
Contact name
Claire Meek
Contact email
Sponsor organisation
Cambridge university hospitals NHS Foundation Trust & University of Cambridge
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Gestational diabetes affects 35,000 pregnancies annually in the UK, causing adverse outcomes to mother and child, such as large-for-gestational age (LGA) and difficult deliveries. Undiagnosed or untreated diabetes in pregnancy is associated with stillbirth, neonatal death, birth injury and congenital anomalies. However, standard testing for gestational diabetes mellitus (GDM) is no longer possible as the oral glucose tolerance test cannot be performed during the Covid-19 pandemic. Normally an OGTT requires a lengthy clinic appointment for women and a lot of resources for the health service in terms of staffing and clinic space. \nAn expert collaborative group used Cambridge service evaluation data to define a new diagnostic strategy for national adoption aimed at identifying women at most risk of GDM. However, depending on the population this will identify 70-90% fewer women. This new strategy also uses random and fasting glucose and HbA1c (which is unreliable in pregnancy)and may identify women that do not have GDM. This new strategy has not yet been evaluated against standard criteria and may prove ineffective in identifying at risk women.\nThis study aims to assess and improve new national guidance for diagnosing GDM. The study will compare glucose concentrations among women who test positive and those who test negative for gestational diabetes to provide some validation that this novel strategy identifies women with higher levels of blood glucose. Our secondary aim is to pilot an alternative OGTT using a continuous glucose monitor to replace the abbreviated diagnostic criteria, should the Covid-19 situation be prolonged.\nWomen will be identified by the clinical team when requiring the 12 or 28 week blood test appointment and sent information about the study. Those who are interested in the study will be invited to participate by telephone, and will be sent information and a consent form by post to minimise Covid-19 risk.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
20/EM/0133
Date of REC Opinion
2 Jun 2020
REC opinion
Further Information Favourable Opinion