Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-07 @ 12:23 AM
Study NCT ID:
NCT02853058
Status:
UNKNOWN
Last Update Posted:
2016-08-02
First Post:
2016-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uterine Artery Pulsatility Index and Materno Fetal Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D050497', 'term': 'Stillbirth'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005313', 'term': 'Fetal Death'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-28', 'studyFirstSubmitDate': '2016-07-24', 'studyFirstSubmitQcDate': '2016-07-28', 'lastUpdatePostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'right uterine artery pulsatility index measurement', 'timeFrame': '15 minutes'}, {'measure': 'left uterine artery pulsatility index measurement', 'timeFrame': '15 minutes'}], 'secondaryOutcomes': [{'measure': 'maternal outcome', 'timeFrame': '2 days', 'description': 'number of patients with hemorrhage, preeclampsie, adversal outcomes'}, {'measure': 'small for gestationnal age (SGA)', 'timeFrame': '1 day', 'description': 'number of neonatal SGA'}, {'measure': 'Apgar Score<7', 'timeFrame': '1 day', 'description': 'number of birth with Apgar score \\<7'}, {'measure': 'distress', 'timeFrame': '1 day', 'description': 'number of cesarean section for distress'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stillbirth', 'hemorrhage'], 'conditions': ['Labor Complication']}, 'referencesModule': {'references': [{'pmid': '25970847', 'type': 'BACKGROUND', 'citation': "Valino N, Giunta G, Gallo DM, Akolekar R, Nicolaides KH. Uterine artery pulsatility index at 30-34 weeks' gestation in the prediction of adverse perinatal outcome. Ultrasound Obstet Gynecol. 2016 Mar;47(3):308-15. doi: 10.1002/uog.14898. Epub 2016 Feb 1."}]}, 'descriptionModule': {'briefSummary': 'High Uterine artery index pulsatility (PI) is associated with small for gestationnal age but also with stillbirth and distress during labor.', 'detailedDescription': 'measures of Uterine artery PI is made with transabdominal color flow during labor. The right and left uterine arteries are visualized at the crossover wth the external iliac arteries. PI is measured and the mean PI of the two vessels is calculated and expressed as multiple of the median (MoM).The outcomes stillbirth, distress and vaginal or cesarean delivery, apgar sore \\<7 at 5 minutes, birth weight and maternal outcomes: preeclampsia, hemorrhage and other complications are noted.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gestationnal age \\>=34 weeks\n* during labor\n\nExclusion Criteria:\n\n* elective cesarean even if labor\n* non elligible ultrasound criteria of good measurement of uterine artery PI'}, 'identificationModule': {'nctId': 'NCT02853058', 'acronym': 'UADLAB', 'briefTitle': 'Uterine Artery Pulsatility Index and Materno Fetal Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University Tunis El Manar'}, 'officialTitle': 'Uterine Artery Pulsatility Index During Labor After 34 Weeks in the Prediction of Materno Fetal Outcomes', 'orgStudyIdInfo': {'id': 'UTARTDOP1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'normal PI', 'description': 'Uterine artery PI expresserd in MoM is \\<95e percentile', 'interventionNames': ['Radiation: normal PI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pathological PI', 'description': 'Uterine artery PI expressed in Multiple of Mediane (MoM) is \\>=95e percentile', 'interventionNames': ['Radiation: pathological PI']}], 'interventions': [{'name': 'normal PI', 'type': 'RADIATION', 'description': 'measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM', 'armGroupLabels': ['normal PI']}, {'name': 'pathological PI', 'type': 'RADIATION', 'description': 'measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM', 'armGroupLabels': ['pathological PI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7000', 'city': 'Bizerte', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'AMIRA AYACHI, Ph D', 'role': 'CONTACT', 'email': 'benmrad.amira@yahoo.fr', 'phone': '53660148', 'phoneExt': '00216'}, {'name': 'Mechaal mouurali, professor', 'role': 'CONTACT', 'email': 'mouralimech@yaho.fr', 'phone': '98693968', 'phoneExt': '00216'}], 'facility': 'University Hospital Bougatfa', 'geoPoint': {'lat': 37.27442, 'lon': 9.87391}}], 'centralContacts': [{'name': 'AMIRA AYACHI, Ph D', 'role': 'CONTACT', 'email': 'benmrad.amira@yahoo.fr', 'phone': '53660148', 'phoneExt': '00216'}], 'overallOfficials': [{'name': 'AMIRA AYACHI, Ph D', 'role': 'STUDY_CHAIR', 'affiliation': 'University Tunis El Manar'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Tunis El Manar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'University Assistant in Obstetrics and gynecology', 'investigatorFullName': 'Amira Ayachi', 'investigatorAffiliation': 'University Tunis El Manar'}}}}