NCT06067867

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
214mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Sep 2023Dec 2043

Study Start

First participant enrolled

September 12, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
20.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2043

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2043

Last Updated

October 5, 2023

Status Verified

September 1, 2023

Enrollment Period

20.2 years

First QC Date

September 28, 2023

Last Update Submit

September 28, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

    Risk factors for the occurrence of subsequent cardio-renal pathologies in patients who had preeclampsia or an event during their pregnancy

    20 years

  • Need for genetic testing

    Identification of patients who will need specialized genetic testing

    20 years

Study Arms (1)

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

Interventions

Data extraction from medical files

Kidney and Pregnancy clinic consultations

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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)
  • +12 more criteria

You may not qualify if:

  • Male patients Menopausal patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

RECRUITING

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Christelle Fosso

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinical research unit

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 5, 2023

Study Start

September 12, 2023

Primary Completion (Estimated)

December 1, 2043

Study Completion (Estimated)

December 1, 2043

Last Updated

October 5, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations