Actively Recruiting
Obstetrical, Endocrine and Metabolic Consequences of Antenatal Dexamethasone Treatment in Pregnant Women at Risk of Congenital Adrenal Hyperplasia
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-12-17
35
Participants Needed
17
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to analyze obstetric, endocrine, and metabolic follow-up data in women treated with dexamethasone (DEX) during pregnancy who are at risk of congenital adrenal hyperplasia. It seeks to understand the occurrence and impact of weight gain, insomnia, edema, stretch marks, arterial hypertension, and gestational diabetes. The study also evaluates pregnancy outcomes and assesses the corticotropic axis during and up to three months after pregnancy to improve management and prevent related health issues. The study includes women treated with DEX during pregnancy, focusing on those with a severe mutation of the CYP21A2 gene in both parents and carrying a female single fetus. Participants have started prenatal DEX treatment for at least 24 hours. This observational study collects retrospective and prospective data from this group to evaluate the effects and outcomes of the treatment. Participants will be monitored through follow-up data collection, including metabolic complications like hypertension and diabetes, adverse effects such as weight gain and insomnia, pregnancy complications, and hormone levels (cortisol and S-DHEA) during and after treatment. The primary outcome is the proportion of mothers developing hypertension and/or diabetes over an average of four years. The study aims to guide better clinical practices and recommendations for managing pregnant women treated with DEX.
CONDITIONS
Brief Title
Dexamethasone and Pregnancy: Maternal Effects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Pregnant with a female fetus
- Pregnancy indicated for antenatal dexamethasone treatment due to severe CYP21A2 gene mutation in both parents
- Single pregnancy
- Started antenatal dexamethasone treatment for at least 24 hours
You will not qualify if you...
- Contraindication to dexamethasone treatment
- Refusal to allow use of personal data
- Legal protection status such as curatorship or guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 4 years
Participants who received antenatal dexamethasone treatment during pregnancy are observed for metabolic complications and adverse effects.
Trial Site Locations
Total: 17 locations
1
Hopital Haut Leveque - Endocrinologie
Bordeaux, France
Actively Recruiting
2
Endocrinologie - Hospices civils de Lyon
Bron, France, 69500
Actively Recruiting
3
Hospices civils de Lyon Biochimie et Biologie moléculaire UM Pathologies endocriniennes
Bron, France, 69500
Actively Recruiting
4
Hospices civils de Lyon Laboratoire de Biologie Médicale Multi Sites
Bron, France, 69500
Actively Recruiting
5
Hospices civils de Lyon Service de médecine de la reproduction
Bron, France, 69500
Actively Recruiting
6
Endocrinologie - CHU Grenoble - Hôpital Michallon
Grenoble, France, 38700
Actively Recruiting
7
Endocrinologie et médecine de la reproduction - Hôpital Bicêtre APHP
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
8
Endocrinologie pédiatrique - Hôpital Bicêtre APHP
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
9
Hopital Bicêtre
Le Kremlin-Bicêtre, France, 94275
Actively Recruiting
10
CHRU Lille - Hôpital Claude Huriez Endocrinologie, diabétologie et métabolisme
Lille, France, 59037
Actively Recruiting
11
Biologie et médecine de la reproduction, centre d'Assistance Médicale à la Procréation - CHU Nantes - Hôpital Mère et Enfant
Nantes, France, 44093
Actively Recruiting
12
Hospital Saint-Antoine, Endocrinology service
Paris, France, 75012
Actively Recruiting
13
Endocrinologie et médecine de la reproduction-Pitié Salpetriere Hospital
Paris, France, 75013
Actively Recruiting
14
Endocrinologie Pédiatrique-Hôpital Robert Debré
Paris, France, 75019
Actively Recruiting
15
Endocrinologie Pédiatrique-Hôpital Universitaire Necker Enfants Malades
Paris, France, 7501
Actively Recruiting
16
CHU de Toulouse - Hôpita Larrey
Toulouse, France, 31059
Actively Recruiting
17
Pédiatrie - Endocrinologie, génétique et gynécologie médicale - CHU Toulouse - Hôpital des enfants
Toulouse, France, 31059
Not Yet Recruiting
Research Team
A
Anne BACHELOT, Pr
I
Imene HADDADOU, CP
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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