Pregnancy-associated Progression of Chronic Kidney Disease: A Study Protocol for the Development and Validation of a Clinical Predictive Tool

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pregnancy-associated Progression of Chronic Kidney Disease: A Study Protocol for the Development and Validation of a Clinical Predictive Tool

Conditions
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Chronic Kidney Diseases, Pregnancy Related

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dataset 1: National Registry of Rare Kidney Diseases<br>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<br>Maternal and laboratory data from East and West Kent in the UK. | |
| Dataset 3: Stockholm Creatinine Measurement<br>An observational dataset with laboratory data from individuals in Stockholm (Sweden) | |
| Dataset 4: Ontario Renal Network Pregnancy Cohort<br>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<br>A combined cohort derived from three obstetric studies within the UK. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |