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临床试验/NCT06067867
NCT06067867招募中不适用

Kidney and Pregnancy Registry

Brugmann University Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2023年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
600
试验地点
1
主要终点
Clinico-biological characteristics of patients

研究概览

简要总结

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Male patients Menopausal patients

结局指标

主要结局

Clinico-biological characteristics of patients

时间窗: 20 years

Risk factors for cardio-renal pathologies

时间窗: 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

时间窗: 20 years

Identification of patients who will need specialized genetic testing

Risk factors for feto-maternal complications

时间窗: 20 years

Epidemiological characteristics of patients

时间窗: 20 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tatiana Besse-Hammer

Head of clinical research unit

Brugmann University Hospital

研究点 (1)

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