Project objectives

1. What is the test performance of self-testing for proteinuria compared to a) Midwife administered proteinuria testing and b) laboratory urinary protein:creatinine ratio (uPCR)?
2. Is self-testing for proteinuria acceptable to both pregnant women and their health professionals and what are the barriers to its implementation? Would it be likely to affect recruitment to a subsequent self-monitoring trial?
3. Does self-monitoring proteinuria add value to the self-monitored blood pressure intervention alone and would it be likely to influence practice?

Changes to project objectives

Project length

Recruitment was less than we hoped as we were restricted to the Oxford sites. Recruitment continued until January 2014 and participants were followed in the study until September 2014. Notes review and data chasing for this study and the linked BuMP study (171) was completed by the end of March 2015.

Brief summary

Background

Protein leaking into the urine combined with high blood pressure defines pre-eclampsia, a condition affecting 2-8% of pregnancies in the UK. Pre-eclampsia is important as it can lead to eclampsia; a serious condition with seizures and a high mortality rate.

Diagnosing pre-eclampsia requires monitoring of blood pressure and urine, typically by midwives at intermittent times during pregnancy, generally coinciding with antenatal visits. Women considered to be at higher risk for pre-eclampsia, for instance due to age or a previous history, require more frequent monitoring.

This project examined the home use of proteinuria dipsticks alongside a study of self-monitoring of blood pressure in higher risk pregnancy. The proposed work aims to evaluate whether testing for protein in the urine by pregnant women themselves is feasible and acceptable.

The overall hypothesis underpinning this work is that self-monitoring proteinuria could improve the detection of pre-eclampsia and add value to a self-monitoring of blood pressure intervention. This will improve women’s involvement in antenatal care, may improve women’s confidence in self-monitored results and by reducing additional visits to midwives and other health professionals help to provide a cost effective intervention.

Aim

To develop sufficient evidence to test a definitive intervention on an adequate scale in a future randomised trial or diagnostic accuracy study.

Methods

A pilot study examining the use of self-monitoring of blood pressure in higher risk pregnancy was recently carried out by this group (NSPCR 171). To investigate whether the home use of proteinuria dipsticks could add value to this intervention we asked a subset of 30 women to additionally test their urine for protein. Women were asked to test using standard urinalysis reagent strips on the day of their antenatal appointments at 28 and 36 weeks pregnant and when they record a self-monitored blood pressure of 140/90 mmHg or more (for a third reading), as this when self-testing, if effective, would be used in practice. Self-testing results were compared to midwife testing and laboratory uPCR analysis.

Results

30 women who had agreed to take part in the BuMP study were asked to additionally test their own urine, all agreed to participate (100%) suggesting that the addition of protein testing would not affect recruitment to a future study of self-monitoring of blood pressure. From 43 comparisons of HP vs participant read dipsticks there were only 3 differences (93% same). Each of these differences was between negative and trace so there was no clinical differences and clinical action was 100% unchanged. From 32 comparisons of participant read dipsticks with uPCR results there were 5 differences (84% the same as UPCR) taking UPCR 0-15 as negative and 15-30 as trace. Again each of the differences was between trace and negative there was no clinic difference and the clinical pathway was 100% unchanged.

We interviewed 15 women who had taken part in BuMP about their experiences of self-monitoring and taking part in the pilot study. One of these women was also testing her own urine. She found self-testing straightforward and felt reassured, empowered and better informed by her involvement in the study.

Conclusion

This simple test could improve the detection of a potentially serious disease. We have found self-testing for proteinuria easy to implement and acceptable to pregnant women. These initial results suggest that women are able to test accurately however a sufficiently powered study is required. If shown to be sufficiently accurate and cost effective self-testing of proteinuria has the potential to be a valuable method of screening for pre-eclampsia in high or higher risk pregnancy, either alone or alongside BP self-monitoring.

Overall we have achieved our aims and are currently putting together this work for publication. We published a Horizon scanning report in 2014 and the team were involved in a related publication in the BMJ.

Plain English summary

Protein leaking into the urine combined with high blood pressure defines pre-eclampsia, a condition affecting around 1 in 25 pregnancies in the UK. Pre-eclampsia is important as it can lead to eclampsia; a serious condition with seizures and a high mortality rate.

Diagnosing pre-eclampsia requires monitoring of blood pressure and urine, typically by midwives at intermittent times during pregnancy, generally coinciding with antenatal visits. Women considered to be at higher risk for pre-eclampsia, for instance due to age or a previous history, require more frequent monitoring.

This project examined the home use of proteinuria dipsticks alongside a study of self-monitoring of blood pressure in higher risk pregnancy. We have carried out an initial study to evaluate if this is feasible and acceptable.

Our results suggest that self-testing for proteinuria in pregnancy is feasible and acceptable to women. We have used these results to bid for further funding to continue work around self-testing in pregnancy and are preparing a manuscript for publication.

Dissemination

Published articles

1. K. Tucker, E. Brunt M. Thompson, R. McManus, C. Crawford, C. Heneghan, N. Robberts and A. Plüddemann (March 2014). Urinalysis self-testing in pregnancy. Horizon scanning report 2014.
   http://www.oxford.dec.nihr.ac.uk/reports-and-resources/horizon-scanning-reports/urinalysis-self-testing-in-pregnancy
2. Hodgkinson JA, Tucker KL, Crawford C, Greenfield SM, Heneghan C, Hinton L, Khan K, Locock L, Mackillop L, McCourt C, Selwood M, McManus RJ. Is self monitoring of blood pressure in pregnancy safe and effective? BMJ. 2014;349:g6616. doi: 10.1136/bmj.g6616.
   http://www.bmj.com/content/349/bmj.g6616.long

Planned articles

1. K L. Tucker, E. Brunt, C. Crawford, L. Hinton, K. Taylor, C. Heneghan1, R. Stevens, L Mackillop, C Bankhead, and R J. McManus.  UDIP: The feasibility of Self-testing for Proteinuria during pregnancy.

Poster presentations

1. L. Mackillop, K. Tucker, L. Loerup R. Kaplan, J. Newstead-Angel (2014) Web-enabled pregnancy: using digital health solutions for the detection and management of medical conditions in pregnancy. (ISOM Oral presentation)
2. L.Hinton, K.L.Tucker, S.Greenfield, R.McManus and L.Locock Blood pressure monitoring in pregnancy: patient and staff perspectives. A qualitative study. (SAPC 2014 oral)
3. E. Brunt, L. Hinton, C. Crawford, C. Redman, I. Sargent, R. McManus and K. Tucker. Feasibility and Acceptability of Self-testing of Proteinuria in Pregnancy. (SAPC 2014 Oral)
4. L.Hinton, K.L.Tucker, S.Greenfield, R.McManus and L.Locock Blood pressure monitoring in pregnancy: patient and staff perspectives. A qualitative study. (EACH 2014)
5. K.L.Tucker J. Hodgkinson, C. Bankhead, S. Greenfield, C. Crawford, C. Heneghan, K. Khan, L. Locock, L.Hinton, C. McCourt, M. Selwood, N. Roberts, R. Stevens and R.J. McManus. Under Pressure: Can self-monitoring improve the detection of pre-eclampsia? (2013 poster)

Public involvement

We involved PPI at an early stage, before developing our initial application. We will continue to involve them as we disseminate of our findings and plan future work. We have found PPI input to be extremely useful and this has been an integral part of our programme grant bid that plans to take this work forward.

Impact

We have shown that self-testing of urine for protein during pregnancy is feasible and acceptable to women. Our initial results suggest self-testing is likely to be as accurate as clinic testing. We have used this data to put together a manuscript for publication and to support a diagnostic test performance cohort study within a 2.5k program grant.

This project was funded by the National Institute for Health Research School for Primary Care Research (project number 213)

Department of Health Disclaimer

The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR School for Primary Care Research, NIHR, NHS or the Department of Health.