Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2026-02-20 @ 6:40 PM
Study NCT ID:
NCT02445261
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2015-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Phone Effects on Umbilical Artery Doppler and Heart Rate Tracing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2015-05-11', 'studyFirstSubmitQcDate': '2015-05-12', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'umbilical artery doppler', 'timeFrame': '5 minutes after hanging up the mobile phone'}], 'secondaryOutcomes': [{'measure': 'fetal heart rate tracing', 'timeFrame': '10 minutes after phone is in the dialing mode for'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MOBILE PHONE ON AND IN AND', 'UMBILICAL ARTERY DOPPLER', 'FETAL CARDIOTOCOGRAPHY', 'GROWTH RESTRICTED FETUS', 'NORMAL GROWTH FETUS'], 'conditions': ['Umbilical Artery Doppler', 'Fetal Heart Rate Tracing']}, 'descriptionModule': {'briefSummary': "Women were instructed not to use the mobile phones for 24 hours before carrying out the initial CTG trace and Doppler ultrasound. For each patient, initial 15 minutes CTG trace recording was done followed by umbilical artery Doppler ultrasound using high resolution ultrasound unit with 3-5 MHz transabdominal transducers (General Electric logic a500, logic a200 City country). Thereafter, the mobile phone (type, in the dialing mode, was put on the mother's abdomen for 10 minutes, concurrently with repeating the 15 minutes CTG trace. The umbilical artery Doppler was repeated 5 minutes after hanging up to avoid the interference with the Doppler machine. The umbilical artery Doppler ultrasound and the recorded fetal heart rate (FHR) strips before and after the mobile phone use were blindly analyzed with respect to umbilical artery resistance indices (RI) and CTG parameters in terms of number of fetal kicks, absence of beat to beat variability, loss of accelerations and the appearance of spontaneous decelerations."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* aged 18 to 40 years pregnant between\n* singleton fetus\n* 32-38 weeks' gestation . They were classified into two groups. Group (A) included 120 women with normally growing fetuses. Group (B) included 70 women with growth-restricted fetuses.\n\nExclusion Criteria:\n\n* presence of medical disorders or obstetric complications (in group A), anomalous fetus and non-reactive fetal CTG in initial CTG trace severe oligohydramnios"}, 'identificationModule': {'nctId': 'NCT02445261', 'briefTitle': 'Mobile Phone Effects on Umbilical Artery Doppler and Heart Rate Tracing', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Effects of Mobile Phone on Umbilical Artery Doppler and Fetal Cardiotogogrphy in Normal and Gowth Restricted Fetuses', 'orgStudyIdInfo': {'id': '133'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'normal growth', 'description': '120 woman with normal fetal growth will be subjected to 15 minutes CTG trace recording before using mobile phone and repeated while the phone is in the dialing mode for 10 minutes. Umbilical artery (UA) Doppler ultrasound will be done after the initial CTG trace and was repeated 5 minutes after hanging up the mobile phone. UA resistance indices, number of fetal kicks, the loss of acceleration and variability, and the appearance of decelerations were assessed', 'interventionNames': ['Radiation: mobile phone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'growth restricted group', 'description': '70 woman with l growth restricted fetus will be subjected to 15 minutes CTG trace recording before using mobile phone and repeated while the phone is in the dialing mode for 10 minutes. Umbilical artery (UA) Doppler ultrasound will be done after the initial CTG trace and was repeated 5 minutes after hanging up the mobile phone. UA resistance indices, number of fetal kicks, the loss of acceleration and variability, and the appearance of decelerations', 'interventionNames': ['Radiation: mobile phone']}], 'interventions': [{'name': 'mobile phone', 'type': 'RADIATION', 'description': 'Each woman was subjected to 15 minutes CTG trace recording before using mobile phone and repeated while the phone is in the dialing mode for 10 minutes. Umbilical artery (UA) Doppler ultrasound was done after the initial CTG trace and was repeated 5 minutes after hanging up the mobile phone.', 'armGroupLabels': ['growth restricted group', 'normal growth']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12151', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ahmed Maged', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '12151', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alainy medical school', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed M Maged', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kasr Alainy medical school'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Ahmed Maged', 'investigatorAffiliation': 'Cairo University'}}}}