Clinical trial NCT05793346: Pregnancy-associated Progression of Chronic Kidney Disease: A Study Protocol for the Development and Validation of a Clinical Predictive Tool
Official title: Pregnancy-associated Progression of Chronic Kidney Disease: A Study Protocol for the Development and Validation of a Clinical Predictive Tool
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Diseases
Pregnancy Related
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with pre-existing chronic kidney disease, defined as eGFR \< 90mls/min/1.73m2 within 24 months of conception.

Brief summary: To develop and validate a tool that estimates the degree of pregnancy-associated progression of renal disease in women with CKD and pregnancy outcomes in an international multicentre cohort study.

Detailed description: The aim of this study is to develop and validate a tool that estimates the degree of pregnancy-associated progression of renal disease in women with CKD and pregnancy outcomes in an international multicentre cohort study. Two prediction models will be developed to estimate the likelihood of both outcomes. The models will be developed and internally validated in one cohort in the United Kingdom and then externally validated using four international datasets.

Eligibility criteria: Inclusion Criteria:

* Women with an estimated Glomerular Filtration Rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) without ethnicity adjustment, less than 90mls/min/1.73m2 within 24 months pre-conception will be included

Exclusion Criteria:

* Women established on dialysis at time of conception
* Multi-fetal pregnancies
* Known inpatient eGFR measurement
* No preconception eGFR within 24 months will be excluded.

Primary outcomes:
measure: Primary outcome a 25% or greater decline in eGFR between six weeks and 12 months postpartum or initiation of dialysis
timeFrame: Six weeks to 12 months postpartum
Secondary outcomes:
measure: Secondary outcome: a preterm birth less than 34 weeks or small for gestational age less than 3rd percentile.
timeFrame: To be recorded within 24 hours of date of delivery (Index event is the day of delivery). This outcome is measured on date of delivery.
Other outcomes:
Locations:
Study officials:
References:
citation: 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. The impact of chronic kidney disease Stages 3-5 on pregnancy outcomes. Nephrol Dial Transplant. 2021 Nov 9;36(11):2008-2017. doi: 10.1093/ndt/gfaa247.
citation: Tong A, Jesudason S, Craig JC, Winkelmayer WC. Perspectives on pregnancy in women with chronic kidney disease: systematic review of qualitative studies. Nephrol Dial Transplant. 2015 Apr;30(4):652-61. doi: 10.1093/ndt/gfu378. Epub 2014 Dec 18.
citation: Piccoli GB, Zakharova E, Attini R, Ibarra Hernandez M, Orozco Guillien A, Alrukhaimi M, Liu ZH, Ashuntantang G, Covella B, Cabiddu G, Li PKT, Garcia-Garcia G, Levin A. Pregnancy in Chronic Kidney Disease: Need for Higher Awareness. A Pragmatic Review Focused on What Could Be Improved in the Different CKD Stages and Phases. J Clin Med. 2018 Nov 5;7(11):415. doi: 10.3390/jcm7110415.