Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-26 @ 5:20 PM
Study NCT ID:
NCT06825806
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2025-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Doppler Indices to Predict Spinal Hypotension During Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2025-02-08', 'studyFirstSubmitQcDate': '2025-02-08', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of the change in pulsatility index to predict spinal hypotension', 'timeFrame': 'baseline and immediately after spinal anesthesia'}], 'secondaryOutcomes': [{'measure': 'accuracy of change in waveform morphology to predict spinal hypotension', 'timeFrame': 'baseline and immediately after spinal anesthesia'}, {'measure': 'baseline shock index to predict hypotension', 'timeFrame': 'baseline'}, {'measure': 'baseline PI to predict spinal hypotension', 'timeFrame': 'baseline'}, {'measure': 'baseline RI to predict hypotension', 'timeFrame': 'baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spinal hypotension; Cesarean section; femoral Doppler'], 'conditions': ['Spinal Hypotension', 'Doppler']}, 'referencesModule': {'references': [{'pmid': '34034957', 'type': 'BACKGROUND', 'citation': 'Yu C, Gu J, Liao Z, Feng S. Prediction of spinal anesthesia-induced hypotension during elective cesarean section: a systematic review of prospective observational studies. Int J Obstet Anesth. 2021 Aug;47:103175. doi: 10.1016/j.ijoa.2021.103175. Epub 2021 May 1.'}, {'pmid': '39848332', 'type': 'BACKGROUND', 'citation': 'Adolf Helmy M, Mansour M, Magdy Milad L, Mohammed Aboelregal E, Magdy Youssef M. Change in femoral artery pulsatility index as a novel predictor of post-spinal anesthesia hypotension in adult patients undergoing infra-umbilical surgeries: A prospective observational study. Anaesth Crit Care Pain Med. 2025 Apr;44(2):101482. doi: 10.1016/j.accpm.2025.101482. Epub 2025 Jan 21. No abstract available.'}, {'pmid': '29090733', 'type': 'BACKGROUND', 'citation': 'Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.'}, {'pmid': '32667274', 'type': 'BACKGROUND', 'citation': 'Kim ES, Sharma AM, Scissons R, Dawson D, Eberhardt RT, Gerhard-Herman M, Hughes JP, Knight S, Marie Kupinski A, Mahe G, Neumyer M, Poe P, Shugart R, Wennberg P, Williams DM, Zierler RE. Interpretation of peripheral arterial and venous Doppler waveforms: A consensus statement from the Society for Vascular Medicine and Society for Vascular Ultrasound. Vasc Med. 2020 Oct;25(5):484-506. doi: 10.1177/1358863X20937665. Epub 2020 Jul 15.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.accpm.2025.101482', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Spinal anesthesia is safe and advisable anesthetic during cesarean section, despite that spinal induced hypotension is a common associated problem. Therefore early recognition of these critical events should take high priority to avoid serious consequences. in this regards several parameters were available to detect spinal hypotension but non is satisfactory till now. Researchers of this study aimed to evaluated the diagnostic accuracy of femoral artery Doppler to predict hypotension'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women undergoing cesarean section', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA II\n* singleton pregnancy\n* full term\n\nExclusion Criteria:\n\n* vascular disease\n* contraindication to spinal anesthesia\n* inability to obtain adequate Doppler'}, 'identificationModule': {'nctId': 'NCT06825806', 'briefTitle': 'Doppler Indices to Predict Spinal Hypotension During Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Femoral Artery Doppler Indices as an Emerging Predictor of Spinal Anesthesia-induced Hypotension in Elective Cesarean Section: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'Doppler and spinal hypotension'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Femoral artery Doppler', 'type': 'DEVICE', 'description': 'Right common femoral artery will be examined before and after spinal anesthesia to evaluate pulsatility index, resisitive index, and waveform morphology'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6890', 'city': 'Cairo', 'state': 'Giza Governorate', 'country': 'Egypt', 'facility': 'Cairo University'}], 'overallOfficials': [{'name': 'Helmy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data regarding this research will be available from the corresponding author upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anesthesia and critical care', 'investigatorFullName': 'Mina Adolf Helmy', 'investigatorAffiliation': 'Cairo University'}}}}