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RECRUITING
NCT06259994

Dexamethasone and Pregnancy: Maternal Effects

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

35

Start Date

2024-09-30

Completion Date

2028-12-30

Last Updated

2024-12-17

Healthy Volunteers

No

Locations (17)

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