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

Not yet recruiting

• Conditions: Pregnancy Related; Chronic Kidney Diseases

• Registration Number: NCT05793346
• Lead Sponsor: King's College London

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.

Study Timeline

• Status Verified: 2023-03
• Study Start: 2023-03
• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-29
• Last Update Submitted: 2023-03-29
• Study First Posted: 2023-03-31
• Last Update Posted: 2023-03-31
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 5000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome a 25% or greater decline in eGFR between six weeks and 12 months postpartum or initiation of dialysis	Six weeks to 12 months postpartum	A \>=25% reduction in eGFR between six weeks and 12 months postpartum or initiation of dialysis.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome: a preterm birth less than 34 weeks or small for gestational age less than 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.	A composite outcome of preterm birth defined as less than 34 weeks gestation and/or SGA \< 3rd percentile.