Chronic Kidney Diseases, Pregnancy Related
Conditions
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.
Interventions
None listed
Sponsors
King's College London
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed