Clinical trial NCT06067867: Kidney and Pregnancy Registry
Official title: Kidney and Pregnancy Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Diseases
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


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

Primary outcomes:
measure: Epidemiological characteristics of patients
timeFrame: 20 years
measure: Clinico-biological characteristics of patients
timeFrame: 20 years
measure: Risk factors for feto-maternal complications
timeFrame: 20 years
measure: Risk factors for cardio-renal pathologies
timeFrame: 20 years
measure: Need for genetic testing
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Christelle Fosso
role: PRINCIPAL_INVESTIGATOR
References: