Actively Recruiting

Age: 18Years +
FEMALE
NCT06259994

Dexamethasone and Pregnancy: Maternal Effects

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-12-17

35

Participants Needed

17

Research Sites

221 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Dexamethasone and Pregnancy: Maternal Effects

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 years or older
  • Pregnancy with an indication for prenatal dexamethasone treatment according to guidelines
  • Both parents have a severe CYP21A2 gene mutation
  • Fetus is female
  • Single pregnancy
  • Prenatal dexamethasone treatment started for at least 24 hours
Not Eligible

You will not qualify if you...

  • Contraindication to dexamethasone treatment
  • Objection to use of data
  • Under legal protection such as curatorship, guardianship, or court-appointed guardianship

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

Hopital Haut Leveque - Endocrinologie

Bordeaux, France

Actively Recruiting

2

Endocrinologie - Hospices civils de Lyon

Bron, France, 69500

Actively Recruiting

3

Hospices civils de Lyon Biochimie et Biologie moléculaire UM Pathologies endocriniennes

Bron, France, 69500

Actively Recruiting

4

Hospices civils de Lyon Laboratoire de Biologie Médicale Multi Sites

Bron, France, 69500

Actively Recruiting

5

Hospices civils de Lyon Service de médecine de la reproduction

Bron, France, 69500

Actively Recruiting

6

Endocrinologie - CHU Grenoble - Hôpital Michallon

Grenoble, France, 38700

Actively Recruiting

7

Endocrinologie et médecine de la reproduction - Hôpital Bicêtre APHP

Le Kremlin-Bicêtre, France, 94270

Actively Recruiting

8

Endocrinologie pédiatrique - Hôpital Bicêtre APHP

Le Kremlin-Bicêtre, France, 94270

Actively Recruiting

9

Hopital Bicêtre

Le Kremlin-Bicêtre, France, 94275

Actively Recruiting

10

CHRU Lille - Hôpital Claude Huriez Endocrinologie, diabétologie et métabolisme

Lille, France, 59037

Actively Recruiting

11

Biologie et médecine de la reproduction, centre d'Assistance Médicale à la Procréation - CHU Nantes - Hôpital Mère et Enfant

Nantes, France, 44093

Actively Recruiting

12

Hospital Saint-Antoine, Endocrinology service

Paris, France, 75012

Actively Recruiting

13

Endocrinologie et médecine de la reproduction-Pitié Salpetriere Hospital

Paris, France, 75013

Actively Recruiting

14

Endocrinologie Pédiatrique-Hôpital Robert Debré

Paris, France, 75019

Actively Recruiting

15

Endocrinologie Pédiatrique-Hôpital Universitaire Necker Enfants Malades

Paris, France, 7501

Actively Recruiting

16

CHU de Toulouse - Hôpita Larrey

Toulouse, France, 31059

Actively Recruiting

17

Pédiatrie - Endocrinologie, génétique et gynécologie médicale - CHU Toulouse - Hôpital des enfants

Toulouse, France, 31059

Not Yet Recruiting

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Research Team

A

Anne BACHELOT, Pr

CONTACT

I

Imene HADDADOU, CP

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Dexamethasone and Pregnancy: Maternal Effects | DecenTrialz