PREDICT
Research type
Research Study
Full title
PRediction of gestational DIabetes in early pregnancy using point of Care Tests ('PREDICT' Study)
IRAS ID
261976
Contact name
Ponnusamy Saravanan
Contact email
Sponsor organisation
University of Warwick
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The primary objective of this observational cohort study is to assess the validity of point-of-care (POC) HbA1c versus venous HbA1c analysed using high performance liquid chromatography in pregnant women at risk of gestational diabetes mellitus (GDM) (n=221). Whole blood samples will be taken from participants at around 12 weeks of gestation during their booking visit and HbA1c measured in the laboratory on fresh and frozen samples. The patient will also be asked to give a capillary blood sample to be analysed by the POC device. Statistical methods will be used to compare the two methods of analysing HbA1c. A secondary outcome will be to examine the utility of POC and venous to predict plasma glucose levels at 24-28 weeks of gestation. Semi-structured interviews will be conducted with a selection of individuals to discuss their experiences of the POC test. Health care professionals will also be asked to discuss their experiences with the devices.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
19/WM/0291
Date of REC Opinion
13 Nov 2019
REC opinion
Further Information Favourable Opinion