NCT Number: NCT06259994
Dexamethasone and Pregnancy: Maternal Effects
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.
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
Primary location
Hopital Haut Leveque - Endocrinologie, Bordeaux, France
About this study
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:
- To assess the prevalence and importance of adverse effects of DEX: weight gain, stretch marks, insomnia in mothers treated with DEX.
- Describe pregnancy outcomes and compare them with a reference population (data from the 2010 French perinatal survey (15)).
- Analyze the corticotropic axis of DEX-treated mothers during and after pregnancy.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- Contraindication to dexamethasone treatment
- Objection to use of data
- Persons under legal protection (curatorship, guardianship), court-appointed guardians
Treatment and study plan
Primary outcomes
-
proportion of patients who developed hypertension and/or diabetes in mothers treated with DEX
Time frame: on completion of studies, on average 4 year
proportion of patients who developed hypertension and/or diabetes in mothers treated with
Secondary outcomes
-
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
Time frame: on completion of studies, on average 4 year
- Assess weight gain in kilograms, stretch marks and insomnia in mothers treated with DEX
- 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)).
- Cortisol and S-DHEA levels during DEX treatment, baseline and regular Synacthen® cortisol levels after DEX discontinuation, duration of hydrocortisone substitution in weeks.
Study contacts
Contact information is provided by the study sponsor or research team.
Anne BACHELOT, Pr
CONTACT
Imene HADDADOU, CP
CONTACT
Sponsors and collaborators
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Other
Registry information
Official study title
Obstetrical, Endocrine and Metabolic Consequences of Antenatal Dexamethasone Treatment in Pregnant Women at Risk of Congenital Adrenal Hyperplasia
Acronym: DEXAPREG
Important dates
- Study start
- 2024
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Feb 14, 2024
- Registry last updated
- Dec 17, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.