Kidney and Pregnancy Registry

Sponsor

Brugmann University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06067867

Collaborator

(none)

600

Enrollment

Location

242.6

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Diseases	Other: Data extraction from medical files

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Kidney and Pregnancy Registry

Actual Study Start Date :

Sep 12, 2023

Anticipated Primary Completion Date :

Dec 1, 2043

Anticipated Study Completion Date :

Dec 1, 2043

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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 [20 years]
Risk factors for the occurrence of subsequent cardio-renal pathologies in patients who had preeclampsia or an event during their pregnancy
Need for genetic testing [20 years]
Identification of patients who will need specialized genetic testing

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Inclusion Criteria:

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

Peri-gravid consultations

Pregnant women with

Pre-existing kidney damage
De novo renal failure (IR)
Proteinuria
Hematuria
Chronic hypertension
Pregnancy hypertension
Renal lithiasis

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Brugmann	Brussels		Belgium	1020

Sponsors and Collaborators

Brugmann University Hospital

Investigators

Principal Investigator: Christelle Fosso, CHU Brugmann

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tatiana Besse-Hammer, Head of clinical research unit, Brugmann University Hospital

ClinicalTrials.gov Identifier:

NCT06067867

Other Study ID Numbers:

CHUB-BrugKidPreg Reg

First Posted:

Oct 5, 2023

Last Update Posted:

Oct 5, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Kidney Diseases

Study Results

No Results Posted as of Oct 5, 2023