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

Status: Recruiting
Location: See all (17) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hopital Haut Leveque - Endocrinologie
RECRUITING
Bordeaux
Endocrinologie - Hospices civils de Lyon
RECRUITING
Bron
Hospices civils de Lyon Biochimie et Biologie moléculaire UM Pathologies endocriniennes
RECRUITING
Bron
Hospices civils de Lyon Laboratoire de Biologie Médicale Multi Sites
RECRUITING
Bron
Hospices civils de Lyon Service de médecine de la reproduction
RECRUITING
Bron
Endocrinologie - CHU Grenoble - Hôpital Michallon
RECRUITING
Grenoble
Endocrinologie et médecine de la reproduction - Hôpital Bicêtre APHP
RECRUITING
Le Kremlin-bicêtre
Endocrinologie pédiatrique - Hôpital Bicêtre APHP
RECRUITING
Le Kremlin-bicêtre
Hopital Bicêtre
RECRUITING
Le Kremlin-bicêtre
CHRU Lille - Hôpital Claude Huriez Endocrinologie, diabétologie et métabolisme
RECRUITING
Lille
Biologie et médecine de la reproduction, centre d'Assistance Médicale à la Procréation - CHU Nantes - Hôpital Mère et Enfant
RECRUITING
Nantes
Endocrinologie et médecine de la reproduction-Pitié Salpetriere Hospital
RECRUITING
Paris
Endocrinologie Pédiatrique-Hôpital Robert Debré
RECRUITING
Paris
Endocrinologie Pédiatrique-Hôpital Universitaire Necker Enfants Malades
RECRUITING
Paris
Hospital Saint-Antoine, Endocrinology service
RECRUITING
Paris
CHU de Toulouse - Hôpita Larrey
RECRUITING
Toulouse
Pédiatrie - Endocrinologie, génétique et gynécologie médicale - CHU Toulouse - Hôpital des enfants
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Anne BACHELOT, Pr
anne.bachelot@aphp.fr
01 42 16 02 46
Backup
Imene HADDADOU, CP
imene.haddadou@aphp.fr
01.42.16.24.98
Time Frame
Start Date: 2024-09-30
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 35
Treatments
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).
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov