Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-31 @ 7:45 AM
Study NCT ID:
NCT05374135
Status:
UNKNOWN
Last Update Posted:
2022-05-16
First Post:
2022-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dexamethasone on Fetal Heart Rate Variables In Case Of Imminent Preterm Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 97}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-10', 'studyFirstSubmitDate': '2022-05-10', 'studyFirstSubmitQcDate': '2022-05-10', 'lastUpdatePostDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in fetal heart rate variability in relation to dexamethasone administration', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fetal Heart Rate or Rhythm Abnormality Affecting Fetus']}, 'descriptionModule': {'briefSummary': 'Effect of dexamethasone on fetal heart rate variability in case of preterm labour: prospective cohort study', 'detailedDescription': 'prospective cohort study on Effect of dexamethasone on fetal heart rate variability in case of preterm labour'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women', 'genderDescription': 'Pregnant women', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm labor\n\nExclusion Criteria:\n\n* Twins'}, 'identificationModule': {'nctId': 'NCT05374135', 'briefTitle': 'Effect of Dexamethasone on Fetal Heart Rate Variables In Case Of Imminent Preterm Labor', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Dexamethasone on Fetal Heart Rate Variables In Case Of Imminent Preterm Labor', 'orgStudyIdInfo': {'id': 'Dexamethasone effect on FHR'}}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Assiut university', 'role': 'CONTACT'}], 'facility': 'Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Ereny W Youssif, Master', 'role': 'CONTACT', 'email': 'Erenywagih@gmail.com', 'phone': '01004252510'}, {'name': 'Tarek A Abdelradi, Professor', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Tarek Kh Al-Hussini', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ereny wagih youssif', 'investigatorFullName': 'Ereny Wagih Youssif', 'investigatorAffiliation': 'Assiut University'}}}}