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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| women treated with dexamethasone during pregnancy at risk of Congenital Adrenal Hyperplasia | All women treated with DEX during pregnancy at risk of Congenital Adrenal Hyperplasia over the defined period (retrospective and prospective). |
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| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients who developed hypertension and/or diabetes in mothers treated with DEX | proportion of patients who developed hypertension and/or diabetes in mothers treated with | on completion of studies, on average 4 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Femme majeure (âge ≥ 18 ans)
Grossesse avec indication de traitement anténatal par dexaméthasone (DEX) en accord avec le PNDS :
Grossesse unique
Ayant commencé un traitement anténatal par DEX depuis au moins 24h
Exclusion Criteria:
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All women treated with dexamethasone during pregnancy at risk of Congenital Adrenal Hyperplasia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne BACHELOT, Pr | Contact | 01 42 16 02 46 | anne.bachelot@aphp.fr | |
| Imene HADDADOU, CP | Contact | 01.42.16.24.98 | imene.haddadou@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Anne BACHELOT, Pr | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Haut Leveque - Endocrinologie | Recruiting | Bordeaux | France |
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| on completion of studies, on average 4 year |
| Endocrinologie - Hospices civils de Lyon | Recruiting | Bron | 69500 | France |
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| Hospices civils de Lyon Biochimie et Biologie moléculaire UM Pathologies endocriniennes | Recruiting | Bron | 69500 | France |
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| Hospices civils de Lyon Laboratoire de Biologie Médicale Multi Sites | Recruiting | Bron | 69500 | France |
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| Hospices civils de Lyon Service de médecine de la reproduction | Recruiting | Bron | 69500 | France |
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| Endocrinologie - CHU Grenoble - Hôpital Michallon | Recruiting | Grenoble | 38700 | France |
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| Endocrinologie et médecine de la reproduction - Hôpital Bicêtre APHP | Recruiting | Le Kremlin-Bicêtre | 94270 | France |
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| Endocrinologie pédiatrique - Hôpital Bicêtre APHP | Recruiting | Le Kremlin-Bicêtre | 94270 | France |
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| Hopital Bicêtre | Recruiting | Le Kremlin-Bicêtre | 94275 | France |
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| CHRU Lille - Hôpital Claude Huriez Endocrinologie, diabétologie et métabolisme | Recruiting | Lille | 59037 | France |
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| Biologie et médecine de la reproduction, centre d'Assistance Médicale à la Procréation - CHU Nantes - Hôpital Mère et Enfant | Recruiting | Nantes | 44093 | France |
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| Hospital Saint-Antoine, Endocrinology service | Recruiting | Paris | 75012 | France |
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| Endocrinologie et médecine de la reproduction-Pitié Salpetriere Hospital | Recruiting | Paris | 75013 | France |
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| Endocrinologie Pédiatrique-Hôpital Robert Debré | Recruiting | Paris | 75019 | France |
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| Endocrinologie Pédiatrique-Hôpital Universitaire Necker Enfants Malades | Recruiting | Paris | 7501 | France |
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| CHU de Toulouse - Hôpita Larrey | Recruiting | Toulouse | 31059 | France |
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| Pédiatrie - Endocrinologie, génétique et gynécologie médicale - CHU Toulouse - Hôpital des enfants | Not yet recruiting | Toulouse | 31059 | France |
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