Dexamethasone During Pregnancy
Conditions
Keywords
Congenital Adrenal Hyperplasia 21 hydroxylase pregnancy
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.
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
Primary ContactAnne BACHELOT, Pr
Backup ContactImene HADDADOU, CP
Outcome results
None listed