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临床试验/NCT06259994
NCT06259994招募中不适用

Obstetrical, Endocrine and Metabolic Consequences of Antenatal Dexamethasone Treatment in Pregnant Women at Risk of Congenital Adrenal Hyperplasia

Assistance Publique - Hôpitaux de Paris17 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年9月30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
35
试验地点
17
主要终点
proportion of patients who developed hypertension and/or diabetes in mothers treated with DEX

研究概览

简要总结

This study will analyze obstetric, endocrine and metabolic follow-up data in women treated with DEX. It will reveal the prevalence and importance of weight gain, insomnia, edema, stretch marks, arterial hypertension and gestational diabetes, describe pregnancy outcome, and analyze the corticotropic axis during and up to 3 months after pregnancy, with the aim of improving the management of these women and preventing comorbidities.

A few studies suggest problems in women treated with DEX during pregnancy. However, all these studies are retrospective, based on self-questionnaires, and have not evaluated all pregnancy outcomes. Moreover, it would appear that a third of women treated with DEX no longer wish to resume the treatment (8). Compliance with treatment is strongly linked to its efficacy. It is therefore important to start investigating the pregnancy outcomes of women treated with DEX. This project is relevant because it has the potential to improve current clinical practice and recommendations related to this treatment, and thus have a direct impact on future patient care. The results of this study will guide us in the management of women presenting an indication for prenatal DEX treatment, and will help to inform the Order of November 15, 2022.

详细描述

Main objective:

The main aim of this study was to assess the incidence of metabolic complications (hypertension and diabetes) in mothers treated with DEX during pregnancy.

Secondary objectives:

  1. To assess the prevalence and importance of adverse effects of DEX: weight gain, stretch marks, insomnia in mothers treated with DEX.
  2. Describe pregnancy outcomes and compare them with a reference population (data from the 2010 French perinatal survey (15)).
  3. Analyze the corticotropic axis of DEX-treated mothers during and after pregnancy.

研究设计

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

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

  • Femme majeure (âge ≥ 18 ans)
  • Grossesse avec indication de traitement anténatal par dexaméthasone (DEX) en accord avec le PNDS :
  • Mutation sévère du gène CYP21A2 chez chacun des parents
  • Fœtus féminin
  • Grossesse unique
  • Ayant commencé un traitement anténatal par DEX depuis au moins 24h

排除标准

  • Contraindication to dexamethasone treatment
  • Objection to use of data
  • Persons under legal protection (curatorship, guardianship), court-appointed guardians

结局指标

主要结局

proportion of patients who developed hypertension and/or diabetes in mothers treated with DEX

时间窗: on completion of studies, on average 4 year

proportion of patients who developed hypertension and/or diabetes in mothers treated with

次要结局

  • Assess weight gain, stretch marks and insomnia in mothers treated with DEX Describe complications and illnesses of pregnancy Cortisol and S-DHEA levels during DEX treatment(on completion of studies, on average 4 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (17)

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