Effects of Dexamethasone on Pregnant Women
Obstetrical, Endocrine and Metabolic Consequences of Antenatal Dexamethasone Treatment in Pregnant Women at Risk of Congenital Adrenal Hyperplasia
This study looks at how taking dexamethasone during pregnancy affects the health of mothers and their babies, including any complications like weight gain and diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 17 sites (Bordeaux and 16 other locations) |
| Trial ID | NCT06259994 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the obstetric, endocrine, and metabolic outcomes in women treated with dexamethasone (DEX) during pregnancy. It will assess the prevalence of complications such as weight gain, insomnia, edema, hypertension, and gestational diabetes, while also describing pregnancy outcomes and analyzing the corticotropic axis during and after pregnancy. The goal is to improve management strategies for these women and prevent associated comorbidities. By comparing outcomes with a reference population, the study seeks to provide a comprehensive understanding of the effects of DEX treatment in pregnancy.
Who should consider this trial
Good fit: Ideal candidates for this study are adult women (18 years and older) who are pregnant and have a medical indication for prenatal dexamethasone treatment.
Not a fit: Patients who have contraindications to dexamethasone treatment or those who object to the use of their data may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of pregnant women treated with dexamethasone, reducing the risk of complications.
How similar studies have performed: While previous studies have suggested complications in women treated with DEX during pregnancy, this study is novel in its comprehensive approach to evaluating pregnancy outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Femme majeure (âge ≥ 18 ans) 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: 1. Contraindication to dexamethasone treatment 2. Objection to use of data 3. Persons under legal protection (curatorship, guardianship), court-appointed guardians
Where this trial is running
Bordeaux and 16 other locations
- Hopital Haut Leveque - Endocrinologie — Bordeaux, France (Recruiting)
- Endocrinologie - Hospices civils de Lyon — Bron, France (Recruiting)
- Hospices civils de Lyon Biochimie et Biologie moléculaire UM Pathologies endocriniennes — Bron, France (Recruiting)
- Hospices civils de Lyon Laboratoire de Biologie Médicale Multi Sites — Bron, France (Recruiting)
- Hospices civils de Lyon Service de médecine de la reproduction — Bron, France (Recruiting)
- Endocrinologie - CHU Grenoble - Hôpital Michallon — Grenoble, France (Recruiting)
- Endocrinologie et médecine de la reproduction - Hôpital Bicêtre APHP — Le Kremlin-Bicêtre, France (Recruiting)
- Endocrinologie pédiatrique - Hôpital Bicêtre APHP — Le Kremlin-Bicêtre, France (Recruiting)
- Hopital Bicêtre — Le Kremlin-Bicêtre, France (Recruiting)
- CHRU Lille - Hôpital Claude Huriez Endocrinologie, diabétologie et métabolisme — Lille, France (Recruiting)
- Biologie et médecine de la reproduction, centre d'Assistance Médicale à la Procréation - CHU Nantes - Hôpital Mère et Enfant — Nantes, France (Recruiting)
- Hospital Saint-Antoine, Endocrinology service — Paris, France (Recruiting)
- Endocrinologie et médecine de la reproduction-Pitié Salpetriere Hospital — Paris, France (Recruiting)
- Endocrinologie Pédiatrique-Hôpital Robert Debré — Paris, France (Recruiting)
- Endocrinologie Pédiatrique-Hôpital Universitaire Necker Enfants Malades — Paris, France (Recruiting)
- CHU de Toulouse - Hôpita Larrey — Toulouse, France (Recruiting)
- Pédiatrie - Endocrinologie, génétique et gynécologie médicale - CHU Toulouse - Hôpital des enfants — Toulouse, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Anne BACHELOT, Pr — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Anne BACHELOT, Pr
- Email: anne.bachelot@aphp.fr
- Phone: 01 42 16 02 46
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.