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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06067867
Other study ID # CHUB-BrugKidPreg Reg
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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