Proteinuria Detection In Pregnancy (U-DIP)
Research type
Research Study
Full title
Accuracy of self-testing for proteinuria during hypertensive pregnancy
IRAS ID
238483
Contact name
Richard McManus
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Previous work has suggested that self-testing of urine during pregnancy may have a similar accuracy to health care professional testing, that self-testing could be easily implemented during an antenatal appointment, and that most women would find self-testing acceptable.
In this study, we wish to determine the accuracy of proteinuria testing by pregnant women with raised blood pressure compared to health professional testing using an automated reader and laboratory testing.
The study will take place across two sites, the John Radcliffe Hospital and Guy’s and St Thomas’s Hospital. We will recruit women with raised blood pressure from 20 weeks into their pregnancy as they attend routine antenatal care appointments. Women who agree to take part will be asked to test their own urine and provide this sample for further testing. Women will also be asked to take a photograph of their test results and transfer them by email to a dedicated research email address using their phone in order to create a database of images for the development of an app to aid at home self-testing, and to look at the feasibility of implementing an app into antenatal care (such an app would require use of a smartphone camera). Women and healthcare professionals will also complete a free text postcard about self-testing to answer questions about acceptability and feasibility. Interviews with healthcare professionals and women who took part in the study will be conducted at the end of the study to discuss their experiences of the study. We will recruit between 275 and 733 women until 110 women with proteinuria have taken part; additionally, 15 healthcare professionals will be recruited to take part in the qualitative interviews and 50 in a set of focus groups. This study is funded by an NIHR research grant.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
18/YH/0208
Date of REC Opinion
21 May 2018
REC opinion
Favourable Opinion