Dexamethasone During PregnancyDEXAPREGNCT06259994
Dexamethasone and Pregnancy: Maternal Effects
An observational study of Dexamethasone During Pregnancy, run by Assistance Publique - Hôpitaux de Paris at 17 sites in France.
Trial 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, arterial hypertension and gestational diabetes, describe pregnancy outcome, and analyze the corticotropic axis during and up… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dexamethasone During Pregnancy
- How many people
- 35 participants
- Where
- 17 sitesFrance
- Study dates
- 30 Sep 2024to 30 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All women treated with dexamethasone during pregnancy at risk of Congenital Adrenal Hyperplasia
Who may be able to join
- 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
Who cannot join
- Contraindication to dexamethasone treatment
- Objection to use of data
- Persons under legal protection (curatorship, guardianship), court-appointed guardians
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
France17 sites, 17 recruiting
- Recruiting
Hopital Haut Leveque - Endocrinologie
Bordeaux
GROUTHIER Virginie
- Recruiting
Endocrinologie - Hospices civils de Lyon
Bron, 69500
Aude Brac de la Perrière, aude.bracdelaperriere@chu-lyon.fr
- Recruiting
Hospices civils de Lyon Biochimie et Biologie moléculaire UM Pathologies endocriniennes
Bron, 69500
Florence Rouger, florence.rouger@chu-lyon.fr
- Recruiting
Hospices civils de Lyon Laboratoire de Biologie Médicale Multi Sites
Bron, 69500
Véronique Tardy, veronique.tardy@chu-lyon.fr
- Recruiting
Hospices civils de Lyon Service de médecine de la reproduction
Bron, 69500
Ingrid Plotton, ingrid.plotton@chu-lyon.fr
- Recruiting
Endocrinologie - CHU Grenoble - Hôpital Michallon
Grenoble, 38700
Justine Critante, Dr, jcristante@chu-grenoble.fr
- Recruiting
Endocrinologie et médecine de la reproduction - Hôpital Bicêtre APHP
Le Kremlin-Bicêtre, 94270
Jacques Pr Young, 01 45 21 73 00, jacques.young@aphp.fr
- Recruiting
Endocrinologie pédiatrique - Hôpital Bicêtre APHP
Le Kremlin-Bicêtre, 94270
Claire Bouvattier, Dr, 01 45 21 78 31, claire.bouvattier@aphp.fr
- Recruiting
Hopital Bicêtre
Le Kremlin-Bicêtre, 94275
Lise Duranteau, MD, PhD
- Recruiting
CHRU Lille - Hôpital Claude Huriez Endocrinologie, diabétologie et métabolisme
Lille, 59037
Stéphanie Espiard, 03 20 44 45 15, stephanie.espiard@live.fr
- Recruiting
Biologie et médecine de la reproduction, centre d'Assistance Médicale à la Procréation - CHU Nantes - Hôpital Mère et Enfant
Nantes, 44093
Agnes Colombel, Dr, agnes.colombel@chu-nantes.fr
- Recruiting
Hospital Saint-Antoine, Endocrinology service
Paris, 75012
Sophie Christin-Maitre, MD, PhD, sophie.christin-maitre@sat.aphp.fr
- Recruiting
Endocrinologie et médecine de la reproduction-Pitié Salpetriere Hospital
Paris, 75013
Anne Bachelot, MD, PhD, anne.bachelot@psl.aphp.fr
- Recruiting
Endocrinologie Pédiatrique-Hôpital Robert Debré
Paris, 75019
MARTINERIE Laetitia, PHD, 014003 2588, laetitia.martinerie@aphp.fr
- Recruiting
Endocrinologie Pédiatrique-Hôpital Universitaire Necker Enfants Malades
Paris, 7501
Michel Polak, MD, PhD, +33144494802, michel.polak@nck.aphp.fr
Laurence Lecomte, PhD, +33 1 71 19 64 94, laurence.lecomte@nck.aphp.fr
- Recruiting
CHU de Toulouse - Hôpita Larrey
Toulouse, 31059
Solange GRUNENWALD, 05 67 77 17 01, grunenwald.s@chu-toulouse.fr
- Not yet recruiting
Pédiatrie - Endocrinologie, génétique et gynécologie médicale - CHU Toulouse - Hôpital des enfants
Toulouse, 31059
Catherine Pienkowski, Dr, 05 34 55 85 56, pienkowski.c@chu-toulouse.fr
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Dexamethasone During Pregnancy
- Keywords
- Congenital Adrenal Hyperplasia 21 hydroxylase pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients who developed hypertension and/or diabetes in mothers treated with DEX
proportion of patients who developed hypertension and/or diabetes in mothers treated with
Measured: on completion of studies, on average 4 year
Secondary outcomes (1)
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
- Assess weight gain in kilograms, stretch marks and insomnia in mothers treated with DEX
- 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)).
- Cortisol and S-DHEA levels during DEX treatment, baseline and regular Synacthen® cortisol levels after DEX discontinuation, duration of hydrocortisone substitution in weeks.
Measured: on completion of studies, on average 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start30 Sep 2024
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dexamethasone During PregnancyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne BACHELOT, Pr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259994
- Sponsor's protocol ID
- APHP231275
- Acronym
- DEXAPREG
- Status last verified
- Dec 2024
- First submitted
- 24 Jan 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstetrical, Endocrine and Metabolic Consequences of Antenatal Dexamethasone Treatment in Pregnant Women at Risk of Congenital Adrenal Hyperplasia
- ClinicalTrials.gov ID
- NCT06259994
- Acronym / sponsor ID
- DEXAPREG / APHP231275
- Conditions
- Dexamethasone During Pregnancy
- Keywords
- Congenital Adrenal Hyperplasia 21 hydroxylase pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women treated with dexamethasone during pregnancy at risk of Congenital Adrenal Hyperplasia
Key inclusion criteria (6 listed)
- Femme majeure (âge ≥ 18 ans)
- Grossesse avec indication de traitement anténatal par dexaméthasone (DEX) en accord avec le PNDS :
- Grossesse unique
- Ayant commencé un traitement anténatal par DEX depuis au moins 24h
Key exclusion criteria (3 listed)
- Contraindication to dexamethasone treatment
- Objection to use of data
- Persons under legal protection (curatorship, guardianship), court-appointed guardians
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne BACHELOT, Pr principal investigator
Assistance Publique - Hôpitaux de Paris
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dexamethasone During Pregnancy, run by Assistance Publique - Hôpitaux de Paris at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne BACHELOT, Pr (01 42 16 02 46, anne.bachelot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients who developed hypertension and/or diabetes in mothers treated with DEX (time frame: on completion of studies, on average 4 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.