Kidney and Pregnancy Registry

Kidney Diseases Clinical Trial

Official title:

Kidney and Pregnancy Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06067867
• Other study ID #: CHUB-BrugKidPreg Reg
• Status: Recruiting
• Start date: September 12, 2023
• Est. completion date: December 2043

Study information

• Verified date: September 2023
• Source: Brugmann University Hospital
• Contact: Christelle Fosso
• Phone: 3224772016
• Email: Christelle.FOSSO[@]chu-brugmann.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2043
• Est. primary completion date: December 2043
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases

Intervention

Other:
• Data extraction from medical files
Data extraction from medical files

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidemiological characteristics of patients		20 years
Primary	Clinico-biological characteristics of patients		20 years
Primary	Risk factors for feto-maternal complications		20 years
Primary	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
Primary	Need for genetic testing	Identification of patients who will need specialized genetic testing	20 years