Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2025-12-29 @ 12:38 PM
Study NCT ID:
NCT02931695
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2016-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Sex Hormones Variation During Third Trimester of Pregnancy and Post-partum on QT Interval Duration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-04', 'studyFirstSubmitDate': '2016-09-15', 'studyFirstSubmitQcDate': '2016-10-11', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in QTcF duration (Corrected for heart rate according to Fridericia method) between third trimester of pregnancy and post-partum.', 'timeFrame': 'third trimester of pregnancy and 3 to 6 months delivery'}], 'secondaryOutcomes': [{'measure': 'Association between circulating sex hormones levels (progesterone, estradiol, testosterone, FSH) and QTcF duration (univariate and multivariate analysis).', 'timeFrame': 'third trimester of pregnancy and 3 to 6 months delivery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post partum'], 'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'QT interval prolongation, corrected for heart rate (QTc), either spontaneous or drug-induced, is associated with an increased risk of torsades de pointes and sudden death. Women are at higher risk of torsades de pointes, particularly during post-partum and the follicular phase.\n\nThe aim of this study is to explore if QTc duration is prolonged during post-partum as compared to the 3rd trimester of pregnancy', 'detailedDescription': 'Sex steroid hormones are known to influence heart repolarization. Overall, estradiol is considered to promote QTc lengthening while progesterone and testosterone shorten QTc. New findings suggest more complex regulation of QTc by sex steroid hormones involving also follicle-stimulating hormone, which is associated to prolongation of QTc. Another important aim of this study is to study the influence of sex hormones on QTc duration.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (\\>18 yo) pregnant women in their third trimester\n* Able to give her consent\n\nExclusion Criteria:\n\n* Concomitant intake of QTcF prolonging drugs\n* Past medical history of cardiovascular or endocrino-metabolic conditions (except hypertension or diabetes)\n* QRS \\>120 msec on electrocardiogram'}, 'identificationModule': {'nctId': 'NCT02931695', 'acronym': 'QuTe', 'briefTitle': 'Influence of Sex Hormones Variation During Third Trimester of Pregnancy and Post-partum on QT Interval Duration', 'organization': {'class': 'OTHER', 'fullName': 'French Cardiology Society'}, 'officialTitle': 'Influence of Sex Hormones Variation During Third Trimester of Pregnancy and Post-partum on QT Interval Duration', 'orgStudyIdInfo': {'id': '2016-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'pregnant women', 'description': 'Women during third trimester of pregnancy and in the first trimester of post partum\n\n* ECG\n* circulating sex hormones levels', 'interventionNames': ['Other: evaluation of QT interval duration', 'Other: circulating sex hormones levels sample']}, {'type': 'OTHER', 'label': 'women in the first trimester of post partum', 'description': 'Women (same in first arm) in the first trimester of post partum\n\n* ECG\n* circulating sex hormones levels', 'interventionNames': ['Other: evaluation of QT interval duration', 'Other: circulating sex hormones levels sample']}], 'interventions': [{'name': 'evaluation of QT interval duration', 'type': 'OTHER', 'description': 'ECG to evaluation of QT interval duration', 'armGroupLabels': ['pregnant women', 'women in the first trimester of post partum']}, {'name': 'circulating sex hormones levels sample', 'type': 'OTHER', 'description': 'Association between circulating sex hormones levels (progesterone, estradiol, testosterone, FSH) and QTcF duration (univariate and multivariate analysis).', 'armGroupLabels': ['pregnant women', 'women in the first trimester of post partum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': "Centre d'investigation Clinique - Paris est", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Joe-Elie SALEM, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre d'investigation Clinique - Paris est"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Cardiology Society', 'class': 'OTHER'}, 'collaborators': [{'name': 'INSERM 1166 ICAN UPMC', 'class': 'UNKNOWN'}, {'name': "CIC1901-Centre d'Investigation Clinique Paris-Est", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}