Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
35 participants
OBSERVATIONAL
2024-09-30
2028-12-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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COHORT
OTHER
Study Groups
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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).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Grossesse unique
4. Ayant commencé un traitement anténatal par DEX depuis au moins 24h
Exclusion Criteria
2. Objection to use of data
3. Persons under legal protection (curatorship, guardianship), court-appointed guardians
18 Years
FEMALE
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Anne BACHELOT, Pr
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hopital Haut Leveque - Endocrinologie
Bordeaux, , France
Endocrinologie - Hospices civils de Lyon
Bron, , France
Hospices civils de Lyon Biochimie et Biologie moléculaire UM Pathologies endocriniennes
Bron, , France
Hospices civils de Lyon Laboratoire de Biologie Médicale Multi Sites
Bron, , France
Hospices civils de Lyon Service de médecine de la reproduction
Bron, , France
Endocrinologie - CHU Grenoble - Hôpital Michallon
Grenoble, , France
Endocrinologie et médecine de la reproduction - Hôpital Bicêtre APHP
Le Kremlin-Bicêtre, , France
Endocrinologie pédiatrique - Hôpital Bicêtre APHP
Le Kremlin-Bicêtre, , France
Hopital Bicêtre
Le Kremlin-Bicêtre, , France
CHRU Lille - Hôpital Claude Huriez Endocrinologie, diabétologie et métabolisme
Lille, , France
Biologie et médecine de la reproduction, centre d'Assistance Médicale à la Procréation - CHU Nantes - Hôpital Mère et Enfant
Nantes, , France
Hospital Saint-Antoine, Endocrinology service
Paris, , France
Endocrinologie et médecine de la reproduction-Pitié Salpetriere Hospital
Paris, , France
Endocrinologie Pédiatrique-Hôpital Robert Debré
Paris, , France
Endocrinologie Pédiatrique-Hôpital Universitaire Necker Enfants Malades
Paris, , France
CHU de Toulouse - Hôpita Larrey
Toulouse, , France
Pédiatrie - Endocrinologie, génétique et gynécologie médicale - CHU Toulouse - Hôpital des enfants
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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GROUTHIER Virginie
Role: primary
Aude Brac de la Perrière
Role: primary
Florence Rouger
Role: primary
Véronique Tardy
Role: primary
Ingrid Plotton
Role: primary
Justine Critante, Dr
Role: primary
Jacques Pr Young
Role: primary
Claire Bouvattier, Dr
Role: primary
Stéphanie Espiard
Role: primary
Agnes Colombel, Dr
Role: primary
Sophie Christin-Maitre, MD, PhD
Role: primary
Anne Bachelot, MD, PhD
Role: primary
MARTINERIE Laetitia, PHD
Role: primary
Michel Polak, MD, PhD
Role: primary
Laurence Lecomte, PhD
Role: backup
Solange GRUNENWALD
Role: primary
Catherine Pienkowski, Dr
Role: primary
Other Identifiers
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APHP231275
Identifier Type: -
Identifier Source: org_study_id