Dexamethasone and Pregnancy: Maternal Effects
- Conditions
- Dexamethasone During Pregnancy
- Registration Number
- NCT06259994
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief 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.
- Detailed Description
Main objective:
The main aim of this study was to assess the incidence of metabolic complications (hypertension and diabetes) in mothers treated with DEX during pregnancy.
Secondary objectives:
1. To assess the prevalence and importance of adverse effects of DEX: weight gain, stretch marks, insomnia in mothers treated with DEX.
2. Describe pregnancy outcomes and compare them with a reference population (data from the 2010 French perinatal survey (15)).
3. Analyze the corticotropic axis of DEX-treated mothers during and after pregnancy.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 35
-
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
- Contraindication to dexamethasone treatment
- Objection to use of data
- Persons under legal protection (curatorship, guardianship), court-appointed guardians
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method proportion of patients who developed hypertension and/or diabetes in mothers treated with DEX on completion of studies, on average 4 year proportion of patients who developed hypertension and/or diabetes in mothers treated with
- Secondary Outcome Measures
Name Time Method 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 1. Assess weight gain in kilograms, stretch marks and insomnia in mothers treated with DEX
2. Describe complications and illnesses of pregnancy, delivery and neonatal outcome: spontaneous or fetal miscarriage, death, hemorrhage in the second or third trimester, or any other medical problem during pregnancy, cesarean section, induced labor, gestational age in days, birth weight in kilograms, etc.
Compare these data with the outcome of the pregnancy, and with a reference population (data from the 2010 French perinatal survey (15)).
3. Cortisol and S-DHEA levels during DEX treatment, baseline and regular Synacthen® cortisol levels after DEX discontinuation, duration of hydrocortisone substitution in weeks.
Trial Locations
- 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 pédiatrique - Hôpital Bicêtre APHP
🇫🇷Le Kremlin Bicêtre, France
Endocrinologie et médecine de la reproduction - 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