Actively Recruiting

Age: 18Years +
FEMALE
ID06259994

Obstetrical, Endocrine and Metabolic Consequences of Antenatal Dexamethasone Treatment in Pregnant Women at Risk of Congenital Adrenal Hyperplasia

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

35

Participants Needed

17

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to analyze obstetric, endocrine, and metabolic follow-up data in women treated with dexamethasone (DEX) during pregnancy who are at risk of congenital adrenal hyperplasia. It seeks to understand the occurrence and impact of weight gain, insomnia, edema, stretch marks, arterial hypertension, and gestational diabetes. The study also evaluates pregnancy outcomes and assesses the corticotropic axis during and up to three months after pregnancy to improve management and prevent related health issues. The study includes women treated with DEX during pregnancy, focusing on those with a severe mutation of the CYP21A2 gene in both parents and carrying a female single fetus. Participants have started prenatal DEX treatment for at least 24 hours. This observational study collects retrospective and prospective data from this group to evaluate the effects and outcomes of the treatment. Participants will be monitored through follow-up data collection, including metabolic complications like hypertension and diabetes, adverse effects such as weight gain and insomnia, pregnancy complications, and hormone levels (cortisol and S-DHEA) during and after treatment. The primary outcome is the proportion of mothers developing hypertension and/or diabetes over an average of four years. The study aims to guide better clinical practices and recommendations for managing pregnant women treated with DEX.

CONDITIONS

Brief Title

Dexamethasone and Pregnancy: Maternal Effects

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 years or older
  • Pregnant with a female fetus
  • Pregnancy indicated for antenatal dexamethasone treatment due to severe CYP21A2 gene mutation in both parents
  • Single pregnancy
  • Started antenatal dexamethasone treatment for at least 24 hours
Not Eligible

You will not qualify if you...

  • Contraindication to dexamethasone treatment
  • Refusal to allow use of personal data
  • Legal protection status such as curatorship or guardianship

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - Approximately 4 years

Participants who received antenatal dexamethasone treatment during pregnancy are observed for metabolic complications and adverse effects.

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

I

Imene HADDADOU, CP

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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