Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-26 @ 2:28 AM
Study NCT ID:
NCT06259994
Status:
RECRUITING
Last Update Posted:
2024-12-17
First Post:
2024-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexamethasone and Pregnancy: Maternal Effects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2024-01-24', 'studyFirstSubmitQcDate': '2024-02-07', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of patients who developed hypertension and/or diabetes in mothers treated with DEX', 'timeFrame': 'on completion of studies, on average 4 year', 'description': 'proportion of patients who developed hypertension and/or diabetes in mothers treated with'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': 'on completion of studies, on average 4 year', 'description': '1. Assess weight gain in kilograms, stretch marks and insomnia in mothers treated with DEX\n2. 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.\n\n Compare these data with the outcome of the pregnancy, and with a reference population (data from the 2010 French perinatal survey (15)).\n3. Cortisol and S-DHEA levels during DEX treatment, baseline and regular Synacthen® cortisol levels after DEX discontinuation, duration of hydrocortisone substitution in weeks.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Congenital Adrenal Hyperplasia 21 hydroxylase pregnancy'], 'conditions': ['Dexamethasone During Pregnancy']}, 'descriptionModule': {'briefSummary': '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.\n\nA 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.', 'detailedDescription': 'Main objective:\n\nThe main aim of this study was to assess the incidence of metabolic complications (hypertension and diabetes) in mothers treated with DEX during pregnancy.\n\nSecondary objectives:\n\n1. To assess the prevalence and importance of adverse effects of DEX: weight gain, stretch marks, insomnia in mothers treated with DEX.\n2. Describe pregnancy outcomes and compare them with a reference population (data from the 2010 French perinatal survey (15)).\n3. Analyze the corticotropic axis of DEX-treated mothers during and after pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All women treated with dexamethasone during pregnancy at risk of Congenital Adrenal Hyperplasia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Femme majeure (âge ≥ 18 ans)\n2. Grossesse avec indication de traitement anténatal par dexaméthasone (DEX) en accord avec le PNDS :\n\n * Mutation sévère du gène CYP21A2 chez chacun des parents\n * Fœtus féminin\n3. Grossesse unique\n4. Ayant commencé un traitement anténatal par DEX depuis au moins 24h\n\nExclusion Criteria:\n\n1. Contraindication to dexamethasone treatment\n2. Objection to use of data\n3. Persons under legal protection (curatorship, guardianship), court-appointed guardians'}, 'identificationModule': {'nctId': 'NCT06259994', 'acronym': 'DEXAPREG', 'briefTitle': 'Dexamethasone and Pregnancy: Maternal Effects', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Obstetrical, Endocrine and Metabolic Consequences of Antenatal Dexamethasone Treatment in Pregnant Women at Risk of Congenital Adrenal Hyperplasia', 'orgStudyIdInfo': {'id': 'APHP231275'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'women treated with dexamethasone during pregnancy at risk of Congenital Adrenal Hyperplasia', 'description': 'All women treated with DEX during pregnancy at risk of Congenital Adrenal Hyperplasia over the defined period (retrospective and prospective).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'GROUTHIER Virginie', 'role': 'CONTACT'}], 'facility': 'Hopital Haut Leveque - Endocrinologie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '69500', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aude Brac de la Perrière', 'role': 'CONTACT', 'email': 'aude.bracdelaperriere@chu-lyon.fr'}], 'facility': 'Endocrinologie - Hospices civils de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '69500', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Florence Rouger', 'role': 'CONTACT', 'email': 'florence.rouger@chu-lyon.fr'}], 'facility': 'Hospices civils de Lyon Biochimie et Biologie moléculaire UM Pathologies endocriniennes', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '69500', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Véronique Tardy', 'role': 'CONTACT', 'email': 'veronique.tardy@chu-lyon.fr'}], 'facility': 'Hospices civils de Lyon Laboratoire de Biologie Médicale Multi Sites', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '69500', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ingrid Plotton', 'role': 'CONTACT', 'email': 'ingrid.plotton@chu-lyon.fr'}], 'facility': 'Hospices civils de Lyon Service de médecine de la reproduction', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '38700', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Justine Critante, Dr', 'role': 'CONTACT', 'phone': 'jcristante@chu-grenoble.fr'}], 'facility': 'Endocrinologie - CHU Grenoble - Hôpital Michallon', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jacques Pr Young', 'role': 'CONTACT', 'email': 'jacques.young@aphp.fr', 'phone': '01 45 21 73 00'}], 'facility': 'Endocrinologie et médecine de la reproduction - Hôpital Bicêtre APHP', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Claire Bouvattier, Dr', 'role': 'CONTACT', 'email': 'claire.bouvattier@aphp.fr', 'phone': '01 45 21 78 31'}], 'facility': 'Endocrinologie pédiatrique - Hôpital Bicêtre APHP', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lise Duranteau, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphanie Espiard', 'role': 'CONTACT', 'email': 'stephanie.espiard@live.fr', 'phone': '03 20 44 45 15'}], 'facility': 'CHRU Lille - Hôpital Claude Huriez Endocrinologie, diabétologie et métabolisme', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '44093', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Agnes Colombel, Dr', 'role': 'CONTACT', 'email': 'agnes.colombel@chu-nantes.fr'}], 'facility': "Biologie et médecine de la reproduction, centre d'Assistance Médicale à la Procréation - CHU Nantes - Hôpital Mère et Enfant", 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75012', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie Christin-Maitre, MD, PhD', 'role': 'CONTACT', 'email': 'sophie.christin-maitre@sat.aphp.fr'}], 'facility': 'Hospital Saint-Antoine, Endocrinology service', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne Bachelot, MD, PhD', 'role': 'CONTACT', 'email': 'anne.bachelot@psl.aphp.fr'}], 'facility': 'Endocrinologie et médecine de la reproduction-Pitié Salpetriere Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75019', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'MARTINERIE Laetitia, PHD', 'role': 'CONTACT', 'email': 'laetitia.martinerie@aphp.fr', 'phone': '014003 2588'}], 'facility': 'Endocrinologie Pédiatrique-Hôpital Robert Debré', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '7501', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Michel Polak, MD, PhD', 'role': 'CONTACT', 'email': 'michel.polak@nck.aphp.fr', 'phone': '+33144494802'}, {'name': 'Laurence Lecomte, PhD', 'role': 'CONTACT', 'email': 'laurence.lecomte@nck.aphp.fr', 'phone': '+33 1 71 19 64 94'}], 'facility': 'Endocrinologie Pédiatrique-Hôpital Universitaire Necker Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Solange GRUNENWALD', 'role': 'CONTACT', 'email': 'grunenwald.s@chu-toulouse.fr', 'phone': '05 67 77 17 01'}], 'facility': 'CHU de Toulouse - Hôpita Larrey', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine Pienkowski, Dr', 'role': 'CONTACT', 'email': 'pienkowski.c@chu-toulouse.fr', 'phone': '05 34 55 85 56'}], 'facility': 'Pédiatrie - Endocrinologie, génétique et gynécologie médicale - CHU Toulouse - Hôpital des enfants', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Anne BACHELOT, Pr', 'role': 'CONTACT', 'email': 'anne.bachelot@aphp.fr', 'phone': '01 42 16 02 46'}, {'name': 'Imene HADDADOU, CP', 'role': 'CONTACT', 'email': 'imene.haddadou@aphp.fr', 'phone': '01.42.16.24.98'}], 'overallOfficials': [{'name': 'Anne BACHELOT, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}