Dexamethasone and Pregnancy: Maternal Effects (DEXAPREG)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Dexamethasone During Pregnancy

Study type: Observational

Funder types: Other

Identifiers

NCT06259994

APHP231275

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

35 participants in 1 patient group

women treated with dexamethasone during pregnancy at risk of Congenital Adrenal Hyperplasia

Description:

All women treated with DEX during pregnancy at risk of Congenital Adrenal Hyperplasia over the defined period (retrospective and prospective).