NCT06259994|Recruiting
Dexamethasone and Pregnancy: Maternal Effects
DEXAPREG
Obstetrical, Endocrine and Metabolic Consequences of Antenatal Dexamethasone Treatment in Pregnant Women at Risk of Congenital Adrenal Hyperplasia
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DEXAPREG
Obstetrical, Endocrine and Metabolic Consequences of Antenatal Dexamethasone Treatment in Pregnant Women at Risk of Congenital Adrenal Hyperplasia
Sponsor study identifier
observational
35
1 country
17
Study Start
September 30, 2024
Actual (reported)Primary Completion
December 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 24, 2024
Actual (reported)February 14, 2024
Actual (reported)September 30, 2024
Actual (reported)December 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
All women treated with DEX during pregnancy at risk of Congenital Adrenal Hyperplasia over the defined period (retrospective and prospective).
All women treated with dexamethasone during pregnancy at risk of Congenital Adrenal Hyperplasia
Hopital Haut Leveque - Endocrinologie
Bordeaux, France
Endocrinologie - Hospices civils de Lyon
Bron, 69500, France
Hospices civils de Lyon Biochimie et Biologie moléculaire UM Pathologies endocriniennes
Bron, 69500, France
Anne BACHELOT, Pr
Assistance Publique - Hôpitaux de Paris
First Submitted
January 24, 2024
First Posted
February 14, 2024
Study Start
September 30, 2024
Actual (reported)Primary Completion
December 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Hospices civils de Lyon Laboratoire de Biologie Médicale Multi Sites
Bron, 69500, France
Hospices civils de Lyon Service de médecine de la reproduction
Bron, 69500, France
Endocrinologie - CHU Grenoble - Hôpital Michallon
Grenoble, 38700, France
Endocrinologie et médecine de la reproduction - Hôpital Bicêtre APHP
Le Kremlin-Bicêtre, 94270, France
Endocrinologie pédiatrique - Hôpital Bicêtre APHP
Le Kremlin-Bicêtre, 94270, France
Hopital Bicêtre
Le Kremlin-Bicêtre, 94275, France
CHRU Lille - Hôpital Claude Huriez Endocrinologie, diabétologie et métabolisme
Lille, 59037, France
Biologie et médecine de la reproduction, centre d'Assistance Médicale à la Procréation - CHU Nantes - Hôpital Mère et Enfant
Nantes, 44093, France
Hospital Saint-Antoine, Endocrinology service
Paris, 75012, France
Endocrinologie et médecine de la reproduction-Pitié Salpetriere Hospital
Paris, 75013, France
Endocrinologie Pédiatrique-Hôpital Robert Debré
Paris, 75019, France
Endocrinologie Pédiatrique-Hôpital Universitaire Necker Enfants Malades
Paris, 7501, France
CHU de Toulouse - Hôpita Larrey
Toulouse, 31059, France
Pédiatrie - Endocrinologie, génétique et gynécologie médicale - CHU Toulouse - Hôpital des enfants
Toulouse, 31059, France
Study Completion
December 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 17, 2024
Record last verified: 2024-12
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