Status:

RECRUITING

Dexamethasone and Pregnancy: Maternal Effects

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Conditions:

Dexamethasone During Pregnancy

Eligibility:

FEMALE

18+ years

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, arteri...

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. ...

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

Key Trial Info

Start Date :

September 30 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 30 2028

Estimated Enrollment :

35 Patients enrolled

Trial Details

Trial ID

NCT06259994

Start Date

September 30 2024

End Date

December 30 2028

Last Update

December 17 2024

Active Locations (17)

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Page 1 of 5 (17 locations)

1

Hopital Haut Leveque - Endocrinologie

Bordeaux, France

2

Endocrinologie - Hospices civils de Lyon

Bron, France, 69500

3

Hospices civils de Lyon Biochimie et Biologie moléculaire UM Pathologies endocriniennes

Bron, France, 69500

4

Hospices civils de Lyon Laboratoire de Biologie Médicale Multi Sites

Bron, France, 69500