Abstract: FR-PO855
Observational Cohort with Embedded Randomised Controlled Trials to Study Pregnancy-Associated Progression of Renal Disease (ORCHARD)
Session Information
- Women's Health and Kidney Diseases
November 03, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Women's Health and Kidney Diseases
- 2200 Women's Health and Kidney Diseases
Authors
- Smith, Priscilla, King's College London, London, United Kingdom
- Dalrymple, Kathryn, King's College London, London, United Kingdom
- Clark, Katherine Rose, King's College London, London, United Kingdom
- Wang, Yanzhong, King's College London, London, United Kingdom
- Harris, Tess M., The PKD Charity, London, United Kingdom
- Webb, Andrew James, King's College London, London, United Kingdom
- Chappell, Lucy C., King's College London, London, United Kingdom
- Bramham, Kate, King's College London, London, United Kingdom
Background
46% of women with moderate-severe chronic kidney disease (CKD) will require dialysis or lose at least 25% of kidney function within six months of delivery with no development of preventative treatments.
Methods
Biological samples, longitudinal and outcome data will be collected in a prospective cohort and eligible women identified to participate in ORCHARD-BEET randomised controlled feasibility trial. Inclusion criteria: singleton pregnancies; 24+6 weeks or less; CKD (pre-pregnancy eGFR<90mls/min/m2 or pregnancy Cr>70µmol/l). Randomisation: 1 to 1. Standard care or daily beetroot juice supplement (nitrate 400mg). Primary outcome: recruitment rate; secondary outcomes: tolerability, acceptability, eGFR change at 6 months postpartum.
Results
118 women consented to participate in the cohort and 104 were randomised to ORCHARD-BEET trial. 65% of eligible participants approached consented to be enrolled in the trial. Cohort maternal baseline characteristics are presented in Table 1. Trial results will be reported in 2024 once follow up complete.
Conclusion
To our knowledge this is the largest prospective cohort study with embedded pragmatic feasibility trial with concurrent biobanking of pregnant participants which is representative of women with moderate and severe CKD. Findings will be used to inform future intervention trials to prevent pregnancy associated progression of kidney disease.
ISRCTN 91211980
Table 1.Baseline Characteristics
| Baseline Characteristic | Cohort(n=118) Mean (SD)/Median (IQR)/N(%) |
| Age, yrs | 34.9(5.3) |
| Smoker | 6(5.1%) |
| Nulliparous | 58(49.2%) |
| Non-White ethnicity | 51(42.2%) |
| Gestation weeks at recruitment | 17(13,21) |
| BMI | 27.8(5.2) |
| High Deprivation* | 53(44.9%) |
| Systolic Blood Pressure | 121(12.6) |
| Diastolic Blood Pressure | 74(9.9) |
| Pre-pregnancy eGFR (ml/min/1.73m2) | 56.7(18.6) |
| Pre-pregnancy uACR (mg/mmol) | 12.5(2.0,61.4) |
| Primary cause of renal disease Polycystic Kidney Disease Glomerular disease Reflux nephropathy Diabetic nephropathy Congenital/inherited Renal transplant Unknown cause/other | -- 10(8.5%) 32(27.1%) 13(11.0%) 4(3.4%) 3(2.5%) 13(11.0%) 43(36.5%) |
| Diabetes | 13(11%) |
| Chronic hypertension | 62(52.5%) |
* Index of Multiple Deprivation UK 2019
Funding
- Private Foundation Support