Changes in serum creatinine values during and after pregnancy in a cohort of women with or without pre-existing chronic kidney disease

Study type
Protocol
Date of Approval
Study reference ID
20_004
Lay Summary

Chronic kidney disease (CKD) is characterized by reduced kidney function and occurs in up to 3.3% of women of childbearing age. Healthy kidneys react to natural changes during pregnancy by increasing the amount of fluid they filter out of the body. However, it is not well understood whether damaged kidneys can react to changes during pregnancy, and it has been suggested that pregnancy may accelerate permanent loss of kidney function in women with CKD. Over the last two decades it has increasingly become possible for women with CKD to complete pregnancy. Therefore, it is important that health care professionals know which women they need to test for CKD or who require close monitoring of kidney function during and after pregnancy. We aim to describe a population of pregnant women with or without CKD and to describe their changes in kidney function during and after pregnancy.

Technical Summary

CKD is characterized by impaired renal function and occurs in up to 3.3% of women of childbearing age. Healthy kidneys increase the filtration rate in reaction to physiological changes during pregnancy. Impaired kidneys may not sufficiently adapt to physiological changes during pregnancy, and there is a concern that pregnancy may accelerate permanent loss of renal function, especially in women with advanced kidney disease. However, evidence on changes in kidney function during and after pregnancy in women with and without CKD is sparse and mostly outdated.
We will conduct a descriptive study in a cohort of pregnant women with or without pre-existing CKD. We will identify pregnant women who delivered a singleton live-birth between 2000 and 2018. We will use the date of delivery and estimate the date of the last menstrual period (LMP) (and we will validate these dates using «Hospital Episode Statistics» data) to define the start and end of the pregnancy. In the study population, we will include all women with a recorded serum creatinine value (SCr) recorded between one year before the LMP and the end of trimester 1, and we will categorize them into one of four groups based on the mean estimated glomerular filtration rate (eGFR [ml/min/1.73m2]): 1) no CKD (eGFR ?90), 2) mild CKD (eGFR <90 and ?60), 3) moderate CKD (eGFR <60 and ?30), 4) severe CKD (eGFR <30). We will compare demographics and comorbidities between CKD severity groups and evaluate changes in SCr measurements during and after pregnancy in all four groups separately (excluding women without any follow up SCr measurement after trimester 1). Our results will support health professionals in decisions regarding which women need to be screened for CKD early in pregnancy, and which women with pre-existing CKD need to be monitored closely during and after pregnancy.

Health Outcomes to be Measured

Key variables (descriptive study):
Delivery, last menstrual period (LMP, will be estimated and validated within the scope of this project), serum creatinine (SCr) measurements recorded during pregnancy and until one year after pregnancy; chronic glomerulonephritis; cystic kidney disease; haemodialysis; kidney transplantation; miscellaneous other renal diseases; hypertension; gestational hypertension; diabetes mellitus; gestational diabetes; pre-eclampsia

Collaborators

Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Carole Marxer - Corresponding Applicant - University Hospital Basel
- Collaborator -
Christoph Meier - Collaborator - University of Basel
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Rishi Desai - Collaborator - Harvard Medical School

Former Collaborators

Christoph Meier - Collaborator - University of Basel
Julia Spoendlin - Collaborator - University of Basel

Linkages

HES Admitted Patient Care