Kidney and Pregnancy Registry

Maternal physiological adaptation to pregnancy plays an important role in the smooth progress of the pregnancy and the healthy growth of the fetus. This physiological adaptation takes place at the level of several organs, including the kidney. Physiological changes during a normal pregnancy take place at the anatomical, glomerular and tubular level.

In the event of pre-existing kidney damage (glomerular and tubular diseases, stone disease, high blood pressure (hypertension) etc...) these adaptations will not be optimal. This will have implications for:

• the course of the pregnancy with the occurrence of feto-maternal complications: miscarriages, pre-eclampsia, intrauterine growth retardation (IUGR), low birth weight, prematurity. The risk of feto-maternal complications increases with the degree of renal failure or with certain pathologies such as lupus.
• progression of kidney disease

Some maternal complications have long-term implications: preeclampsia is associated with a high risk of subsequent cardiovascular and renal complications. Pregnancies in these patients are high-risk pregnancies and require specialized management by an experienced group of gynecologists and nephrologists.

The creation of a retrospective and prospective register by collecting demographic, clinical, biological, radiological and genetic data concerning patients at each consultation within the CHU Brugmann Hospital will allow:

• to establish the epidemiological and clinico-biological characteristics of the patients followed at the Kidney and Pregnancy Clinic at the CHU Brugmann Hospital
• to analyze the risk factors for feto-maternal complications
• to analyze the risk factors for the occurrence of subsequent cardio-renal pathologies in patients who have had preeclampsia or an event during their pregnancy
• to identify patients who will need specialized genetic testing

Study Overview

• Status: Recruiting
• Conditions: Kidney Diseases
• Intervention / Treatment: Other: Data extraction from medical files

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Christelle Fosso; Phone Number: 3224772016; Email: Christelle.FOSSO@chu-brugmann.be

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • Recruiting
    • CHU Brugmann
    • Contact: Christelle Fosso; Phone Number: 3224772016; Email: Christelle.FOSSO@chu-brugmann.be
    • Principal Investigator: Christelle Fosso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients followed at the Kidney and Pregnancy clinic pre-conception, during pregnancy and postpartum and patients subsequently referred to nephrological follow-up

Description

Inclusion Criteria:

1. Pre-conception consultations

   Woman of childbearing age with:

   • Renal damage (glomerular, tubular disease, renal lithiasis, systemic disease, metabolic diseases, congenital diseases, etc.)
   • Hematological disorders (sickle cell disease)
   • Kidney transplantation
   • High blood pressure (hypertension)
   • Pre-kidney transplant assessment in progress for discussion of contraception and pregnancy after kidney transplantation
   • Preeclampsia
   • Multiple miscarriages
   • IUGR and low birth weight in the fetus
   • Family history of kidney disease

2. Peri-gravid consultations

   Pregnant women with

   • Pre-existing kidney damage
   • De novo renal failure (IR)
   • Proteinuria
   • Hematuria
   • Chronic hypertension
   • Pregnancy hypertension
   • Renal lithiasis
3. Postpartum consultations

Postpartum women with

• Early/late pre-eclampsia
• Eclampsia / Hemolysis Elevated Liver enzymes Low Platelet (HELLP) syndrome
• Pregnancy hypertension
• Postpartum hemorrhage
• De novo renal failure postpartum

Exclusion Criteria:

Male patients Menopausal patients

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Kidney and Pregnancy clinic consultations; Patients followed at the Kidney and Pregnancy clinic pre-conception, during pregnancy and postpartum and patients subsequently referred to nephrological follow-up	Other: Data extraction from medical files; Data extraction from medical files

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epidemiological characteristics of patients		20 years
Clinico-biological characteristics of patients		20 years
Risk factors for feto-maternal complications		20 years
Risk factors for cardio-renal pathologies	Risk factors for the occurrence of subsequent cardio-renal pathologies in patients who had preeclampsia or an event during their pregnancy	20 years
Need for genetic testing	Identification of patients who will need specialized genetic testing	20 years

Collaborators and Investigators

• Sponsor: Brugmann University Hospital
• Investigators: Principal Investigator: Christelle Fosso, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Estimated): December 1, 2043
• Study Completion (Estimated): December 1, 2043

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases
• Other Study ID Numbers: CHUB-BrugKidPreg Reg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No