Dexamethasone and Pregnancy: Maternal Effects (DEXAPREG)

December 12, 2024 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France
        • Recruiting
        • Hopital Haut Leveque - Endocrinologie
        • Contact:
          • GROUTHIER Virginie
      • Bron, France, 69500
      • Bron, France, 69500
        • Recruiting
        • Hospices civils de Lyon Biochimie et Biologie moléculaire UM Pathologies endocriniennes
        • Contact:
      • Bron, France, 69500
        • Recruiting
        • Hospices civils de Lyon Laboratoire de Biologie Médicale Multi Sites
        • Contact:
      • Bron, France, 69500
        • Recruiting
        • Hospices civils de Lyon Service de médecine de la reproduction
        • Contact:
      • Grenoble, France, 38700
        • Recruiting
        • Endocrinologie - CHU Grenoble - Hôpital Michallon
        • Contact:
          • Justine Critante, Dr
          • Phone Number: jcristante@chu-grenoble.fr
      • Le Kremlin Bicêtre, France, 94270
        • Recruiting
        • Endocrinologie pédiatrique - Hôpital Bicêtre APHP
        • Contact:
      • Le Kremlin-Bicêtre, France, 94275
        • Recruiting
        • Hôpital Bicêtre
        • Principal Investigator:
          • Lise Duranteau, MD, PhD
      • Le Kremlin-Bicêtre, France, 94270
        • Recruiting
        • Endocrinologie et médecine de la reproduction - Hôpital Bicêtre APHP
        • Contact:
      • Lille, France, 59037
        • Recruiting
        • CHRU Lille - Hôpital Claude Huriez Endocrinologie, diabétologie et métabolisme
        • Contact:
      • Nantes, France, 44093
        • Recruiting
        • Biologie et médecine de la reproduction, centre d'Assistance Médicale à la Procréation - CHU Nantes - Hôpital Mère et Enfant
        • Contact:
      • Paris, France, 75012
      • Paris, France, 75013
        • Recruiting
        • Endocrinologie et médecine de la reproduction-Pitié Salpetriere Hospital
        • Contact:
      • Paris, France, 75019
        • Recruiting
        • Endocrinologie Pédiatrique-Hôpital Robert Debré
        • Contact:
      • Paris, France, 7501
        • Recruiting
        • Endocrinologie Pédiatrique-Hôpital Universitaire Necker Enfants Malades
        • Contact:
        • Contact:
      • Toulouse, France, 31059
      • Toulouse, France, 31059
        • Not yet recruiting
        • Pédiatrie - Endocrinologie, génétique et gynécologie médicale - CHU Toulouse - Hôpital des enfants
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of patients who developed hypertension and/or diabetes in mothers treated with DEX
Time Frame: on completion of studies, on average 4 year
proportion of patients who developed hypertension and/or diabetes in mothers treated with
on completion of studies, on average 4 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: on completion of studies, on average 4 year
  1. Assess weight gain in kilograms, stretch marks and insomnia in mothers treated with DEX

  2. Describe complications and illnesses of pregnancy, delivery and neonatal outcome: spontaneous or fetal miscarriage, death, hemorrhage in the second or third trimester, or any other medical problem during pregnancy, cesarean section, induced labor, gestational age in days, birth weight in kilograms, etc.

    Compare these data with the outcome of the pregnancy, and with a reference population (data from the 2010 French perinatal survey (15)).

  3. Cortisol and S-DHEA levels during DEX treatment, baseline and regular Synacthen® cortisol levels after DEX discontinuation, duration of hydrocortisone substitution in weeks.
on completion of studies, on average 4 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Anne Bachelot, Pr, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2024

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

January 24, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • APHP231275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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