Clinical trial NCT06259994: Dexamethasone and Pregnancy: Maternal Effects
Official title: Obstetrical, Endocrine and Metabolic Consequences of Antenatal Dexamethasone Treatment in Pregnant Women at Risk of Congenital Adrenal Hyperplasia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dexamethasone During Pregnancy
Keywords: Congenital Adrenal Hyperplasia 21 hydroxylase pregnancy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women treated with dexamethasone during pregnancy at risk of Congenital Adrenal Hyperplasia

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.

Eligibility 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

Primary outcomes:
measure: proportion of patients who developed hypertension and/or diabetes in mothers treated with DEX
timeFrame: on completion of studies, on average 4 year
Secondary outcomes:
measure: 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
timeFrame: on completion of studies, on average 4 year
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hopital Haut Leveque - Endocrinologie
city: Bron
country: France
facility: Endocrinologie - Hospices civils de Lyon
city: Bron
country: France
facility: Hospices civils de Lyon Biochimie et Biologie moléculaire UM Pathologies endocriniennes
city: Bron
country: France
facility: Hospices civils de Lyon Laboratoire de Biologie Médicale Multi Sites
city: Bron
country: France
facility: Hospices civils de Lyon Service de médecine de la reproduction
city: Grenoble
country: France
facility: Endocrinologie - CHU Grenoble - Hôpital Michallon
city: Le Kremlin Bicêtre
country: France
facility: Endocrinologie pédiatrique - Hôpital Bicêtre APHP
city: Le Kremlin-Bicêtre
country: France
facility: Endocrinologie et médecine de la reproduction - Hôpital Bicêtre APHP
city: Le Kremlin-Bicêtre
country: France
facility: Hopital Bicêtre
city: Lille
country: France
facility: CHRU Lille - Hôpital Claude Huriez Endocrinologie, diabétologie et métabolisme
city: Nantes
country: France
facility: Biologie et médecine de la reproduction, centre d'Assistance Médicale à la Procréation - CHU Nantes - Hôpital Mère et Enfant
city: Paris
country: France
facility: Hospital Saint-Antoine, Endocrinology service
city: Paris
country: France
facility: Endocrinologie et médecine de la reproduction-Pitié Salpetriere Hospital
city: Paris
country: France
facility: Endocrinologie Pédiatrique-Hôpital Robert Debré
city: Paris
country: France
facility: Endocrinologie Pédiatrique-Hôpital Universitaire Necker Enfants Malades
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpita Larrey
city: Toulouse
country: France
facility: Pédiatrie - Endocrinologie, génétique et gynécologie médicale - CHU Toulouse - Hôpital des enfants
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Anne BACHELOT, Pr
role: PRINCIPAL_INVESTIGATOR
References: