This is a preview of subscription content, log in via an institution to check access.
Data availability
The datasets generated and/or analysed during the current study are/will be available upon request from the Chief Investigator, Dr Kate Bramham (kate.bramham@kcl.ac.uk) subject to ethical review and authorisation by the ORCHARD Trial Group.
References
Wiles K, Webster P, Seed PT, Bennett-Richards K, Bramham K, Brunskill N, Carr S, Hall M, Khan R, Nelson-Piercy C, Webster LM, Chappell LC, Lightstone L (2021) The impact of chronic kidney disease Stages 3–5 on pregnancy outcomes. Nephrol Dial Transplant 36:2008–2017
Jones DC, Hayslett JP (1996) Outcome of pregnancy in women with moderate or severe renal insufficiency. N Engl J Med 335:226–232
Imbasciati E, Gregorini G, Cabiddu G et al (2007) Pregnancy in CKD stages 3 to 5: fetal and maternal outcomes. Am J Kidney Dis 49:753–762
Bramham K, Seed PT, Lightstone L et al (2016) Diagnostic and predictive biomarkers for pre-eclampsia in patients with established hypertension and chronic kidney disease. Kidney Int 89:874–885
Kincaid-Smith P, North RA, Fairley KF, Kloss M, Ihle BU (1995) Prevention of pre-eclampsia in high risk women with renal disease: a prospective randomized trial of heparin and dipyridamole. Nephrology 1(4):297–300
Moran P, Baylis PH, Lindheimer MD et al (2003) Glomerular ultrafiltration in normal and preeclamptic pregnancy. J Am Soc Nephrol 14:648–652
Conrad KP, Vernier KA (1989) Plasma level, urinary excretion, and metabolic production of cGMP during gestation in rats. Am J Physiol 257:R847-853
Deng A, Engels K, Baylis C (1996) Impact of nitric oxide deficiency on blood pressure and glomerular hemodynamic adaptations to pregnancy in the rat. Kidney Int 50:1132–1138
Kopp L, Paradiz G, Tucci JR (1977) Urinary excretion of cyclic 3’,5’-adenosine monophosphate and cyclic 3’,5’-guanosine monophosphate during and after pregnancy. J Clin Endocrinol Metab 44:590–594
Acknowledgements
The authors would like to acknowledge our funder Kidney Research UK, sponsor King’s College Hospital NHS Trust, King’s Clinical Trials Unit, NIHR Portfolio Team, NIHR Biomedical Research Centre at St Thomas’ Hospital.
Funding
Kidney Research UK Stoneygate Research Award.
Author information
Authors and Affiliations
Contributions
First draft written by PS, KB and KD, all authors contributed to editing and agreeing final draft.
Corresponding author
Ethics declarations
Conflict of interest
A.J.W. holds shares in HeartBeet Ltd, which receives a royalty from James White Drinks Ltd, which manufactures the beetroot juice used in this study. The other authors declare no competing or commercial interests related to this study.
Ethical approval
All research was conducted according to the Declaration of Helsinki and principles of Good Clinical Practice. Ethics approval was prospectively granted by West of Scotland REC3 (19/WS/0197) and London–City REC (20/LO/0009). No research activities were undertaken prior to written informed consent from adult participants with capacity.
Trial Registration and status
ISRCTN 91211980. The trial closed recruitment April 2023. Results will be reported once follow-up completed for all participants.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Supplementary Information
Below is the link to the electronic supplementary material.
Rights and permissions
About this article
Cite this article
Smith, P., Dalrymple, K., Clark, K. et al. ORCHARD: a model for conducting pragmatic randomised trials in pregnancy. J Nephrol (2024). https://doi.org/10.1007/s40620-024-01952-5
Received:
Accepted:
Published:
DOI: https://doi.org/10.1007/s40620-024-01952-5