ClinicalTrials.gov record NCT06259994

Dexamethasone and Pregnancy: Maternal Effects

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexFemale
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational cohort study collects clinical and laboratory data on women given dexamethasone during pregnancy because of risk of congenital adrenal hyperplasia. It aims to measure how often treated mothers develop metabolic complications (hypertension, diabetes), to document side effects such as weight gain, stretch marks and insomnia, and to describe pregnancy outcomes. The study includes retrospective and prospective data and analyzes the corticotropic (stress-hormone) axis during and up to three months after pregnancy.

What it is studying. The study is assessing the incidence of maternal metabolic complications (hypertension and diabetes), the prevalence and severity of adverse effects (weight gain, stretch marks, insomnia), pregnancy outcomes compared with a reference population, and hormonal (corticotropic) measures during and after dexamethasone exposure in pregnancy.

What the researchers hope to learn. Scientific goals: 1) measure how often hypertension and/or diabetes occur in mothers treated with antenatal dexamethasone; 2) document frequency and severity of maternal side effects (weight gain, stretch marks, insomnia); 3) describe pregnancy, delivery, and neonatal outcomes versus a reference population; 4) analyze corticotropic-axis measures (cortisol, S‑DHEA, Synacthen® responses) and timing of any hydrocortisone substitution.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Femme majeure (âge ≥ 18 ans)
  • 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
  • Grossesse unique
  • Ayant commencé un traitement anténatal par DEX depuis au moins 24h

Exclusion criteria

  • Contraindication to dexamethasone treatment
  • Objection to use of data
  • Persons under legal protection (curatorship, guardianship), court-appointed guardians

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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:

  • To assess the prevalence and importance of adverse effects of DEX: weight gain, stretch marks, insomnia in mothers treated with DEX.
  • Describe pregnancy outcomes and compare them with a reference population (data from the 2010 French perinatal survey (15)).
  • Analyze the corticotropic axis of DEX-treated mothers during and after pregnancy.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will allow researchers to collect and review pregnancy and medical records (pregnancy outcomes, delivery details, neonatal data). They may have blood tests during DEX treatment to measure cortisol and S‑DHEA, and after stopping DEX undergo Synacthen® (ACTH stimulation) testing to assess the corticotropic axis and record any hydrocortisone replacement. The study includes both retrospective and prospective participants and involves follow-up during pregnancy and for up to three months after delivery. Researchers will also document symptoms such as weight gain, stretch marks, insomnia, and any diagnoses of hypertension or gestational diabetes.

How the study is structured. An observational cohort study using both retrospective and prospective clinical data. No experimental treatment is assigned by the study. Researchers collect medical records, pregnancy outcome data, and hormone measurements (including cortisol and S‑DHEA), and compare outcomes with a reference population.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Dexamethasone During Pregnancy. Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on congenital adrenal hyperplasia

Clinical trials43 trials listed for congenital adrenal hyperplasiaEvery trial the registry lists for congenital adrenal hyperplasia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in congenital adrenal hyperplasia researchLatest monthly update: September 2026. Includes: Bedtime hydrocortisone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Sep 30, 2024
Primary completion
Dec 30, 2028 (estimated)
Study completion
Dec 30, 2028 (estimated)
Target enrollment
35 participants (estimated)
Last updated on registry
Dec 17, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Assistance Publique - Hôpitaux de Paris

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (17)

  • Hopital Haut Leveque - EndocrinologieRecruiting

    Bordeaux · France

    • GROUTHIER Virginie
  • Endocrinologie - Hospices civils de LyonRecruiting

    Bron, 69500 · France

  • Hospices civils de Lyon Biochimie et Biologie moléculaire UM Pathologies endocriniennesRecruiting

    Bron, 69500 · France

  • Hospices civils de Lyon Laboratoire de Biologie Médicale Multi SitesRecruiting

    Bron, 69500 · France

  • Hospices civils de Lyon Service de médecine de la reproductionRecruiting

    Bron, 69500 · France

  • Endocrinologie - CHU Grenoble - Hôpital MichallonRecruiting

    Grenoble, 38700 · France

  • Endocrinologie et médecine de la reproduction - Hôpital Bicêtre APHPRecruiting

    Le Kremlin-Bicêtre, 94270 · France

  • Endocrinologie pédiatrique - Hôpital Bicêtre APHPRecruiting

    Le Kremlin-Bicêtre, 94270 · France

  • Hopital BicêtreRecruiting

    Le Kremlin-Bicêtre, 94275 · France

    • Lise Duranteau, MD, PhD
  • CHRU Lille - Hôpital Claude Huriez Endocrinologie, diabétologie et métabolismeRecruiting

    Lille, 59037 · France

Terms used on this page · explanations by MedicalUpdates.ai

follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
Contraindication
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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