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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dataset 1: National Registry of Rare Kidney Diseases | This dataset is the: National Registry of Rare Kidney Diseases from the UK Renal Registry, this is a UK-wide, linked dataset. This cohort includes any woman who has previously had a previous diagnosis of kidney disease in the UK with maternity records and who has consented to participate. | ||
| Dataset 2: Kent Integrated Data | Maternal and laboratory data from East and West Kent in the UK. | ||
| Dataset 3: Stockholm Creatinine Measurement | An observational dataset with laboratory data from individuals in Stockholm (Sweden) | ||
| Dataset 4: Ontario Renal Network Pregnancy Cohort | A population-based cohort of women in Ontario who had an obstetric delivery with outpatient laboratory data. | ||
| Dataset 5: Combined cohort of three obstetric studies within the UK | A combined cohort derived from three obstetric studies within the UK. |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome a 25% or greater decline in eGFR between six weeks and 12 months postpartum or initiation of dialysis | A >=25% reduction in eGFR between six weeks and 12 months postpartum or initiation of dialysis. | Six weeks to 12 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome: a preterm birth less than 34 weeks or small for gestational age less than 3rd percentile. | A composite outcome of preterm birth defined as less than 34 weeks gestation and/or SGA < 3rd percentile. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Women with pre-existing chronic kidney disease, defined as eGFR < 90mls/min/1.73m2 within 24 months of conception.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33313680 | Background | 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. | |
| 25523452 | Background |
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There is no plan to share individual participant data.
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 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. |
| 30400594 | Background | 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |