Kidney and Pregnancy Registry

NCT ID: NCT06067867

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-12
• Study Completion Date: 2043-12-31

Brief Summary

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

Conditions

Kidney Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Data extraction from medical files

Intervention Type: OTHER

Data extraction from medical files

Interventions

Data extraction from medical files

Data extraction from medical files

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brugmann University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tatiana Besse-Hammer

Head of clinical research unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christelle Fosso

Role: PRINCIPAL_INVESTIGATOR

CHU Brugmann

Locations

CHU Brugmann

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Christelle Fosso

Role: CONTACT

Christelle.FOSSO@chu-brugmann.be

3224772016

Facility Contacts

Christelle Fosso

Role: primary

Christelle.FOSSO@chu-brugmann.be

3224772016

Other Identifiers

CHUB-BrugKidPreg Reg

Identifier Type: -

Identifier Source: org_study_id