Dexamethasone and Pregnancy: Maternal Effects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Dexamethasone During Pregnancy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Obstetrical, Endocrine and Metabolic Consequences of Antenatal Dexamethasone Treatment in Pregnant Women at Risk of Congenital Adrenal Hyperplasia
Overview
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.
Detailed description
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.
Primary outcome measures
- proportion of patients who developed hypertension and/or diabetes in mothers treated with DEX [Time frame: on completion of studies, on average 4 year]
Secondary outcome measures (1)
- 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 [Time frame: on completion of studies, on average 4 year]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Contraindication to dexamethasone treatment
- Objection to use of data
- Persons under legal protection (curatorship, guardianship), court-appointed guardians
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 17 centers
- Hopital Haut Leveque - Endocrinologie — Bordeaux
- Endocrinologie - Hospices civils de Lyon — Bron
- Hospices civils de Lyon Biochimie et Biologie moléculaire UM Pathologies endocriniennes — Bron
- Hospices civils de Lyon Laboratoire de Biologie Médicale Multi Sites — Bron
- Hospices civils de Lyon Service de médecine de la reproduction — Bron
- Endocrinologie - CHU Grenoble - Hôpital Michallon — Grenoble
- Endocrinologie et médecine de la reproduction - Hôpital Bicêtre APHP — Le Kremlin-Bicêtre
- Endocrinologie pédiatrique - Hôpital Bicêtre APHP — Le Kremlin-Bicêtre
- … and 9 more centers
Identifiers
NCT: NCT06259994 · APHP231275