Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-01-01 @ 9:54 AM
Study NCT ID:
NCT07056166
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2025-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Predictors of Difficulty in Performing Epidural Anesthesia for Labor in Pregnant Patients.
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': 563}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2025-06-20', 'studyFirstSubmitQcDate': '2025-06-28', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Difficulty of epidural catheter placement', 'timeFrame': 'Periprocedural', 'description': 'Defined as the need for more than one puncture attempt (exiting the skin with the needle) or the involvement of a second operator to successfully place the epidural catheter.'}], 'secondaryOutcomes': [{'measure': 'Number of puncture attempts', 'timeFrame': 'Periprocedural', 'description': 'Number of attempts required to successfully insert the epidural catheter.'}, {'measure': '(Predictor of difficult Epidural) Distance from skin to spinous process at epidural placement level', 'timeFrame': 'Periprocedural', 'description': 'The distance measured in cm between the skin surface and the spinous process at the intended epidural insertion site, assessed using ultrasound scanning.'}, {'measure': '(Predictor of difficult Epidural) Distance between spinous processes', 'timeFrame': 'Periprocedural', 'description': 'Measured in centimeters by ultrasound to assess interspinous space width.'}, {'measure': '(Predictor of difficult Epidural) Distance from skin to transverse process', 'timeFrame': 'Periprocedural', 'description': 'Measured in centimeters by ultrasound to assess distance between skin and transverse process.'}, {'measure': '(Predictor of difficult Epidural) Patient age', 'timeFrame': 'Baseline', 'description': 'Measured in years'}, {'measure': '(Predictor of difficult Epidural) Pre-pregnancy weight', 'timeFrame': 'Baseline', 'description': 'Measured in kg'}, {'measure': '(Predictor of difficult Epidural) Current weight', 'timeFrame': 'Baseline', 'description': 'Measured in kg'}, {'measure': '(Predictor of difficult Epidural) Body Mass Index (BMI)', 'timeFrame': 'Baseline', 'description': 'Measured in kg/cm2'}, {'measure': '(Predictor of difficult Epidural) Palpability of spinous processes', 'timeFrame': 'Periprocedural', 'description': 'Measured as "Yes", "Not completely", "No"'}, {'measure': '(Predictor of difficult Epidural) Previous spinal surgery', 'timeFrame': 'Baseline', 'description': '"Yes" or "No" variable. Accounting for any type of vertebral surgery'}, {'measure': '(Predictor of difficult Epidural) Presence of scoliosis', 'timeFrame': 'Baseline', 'description': '"Yes" or "No" variable.'}, {'measure': '(Predictor of difficult Epidural) Operator Experience', 'timeFrame': 'Periprocedural', 'description': 'Operator related. Defined as the number of epidural catheter previously positioned'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epidural analgesia', 'Pregnancy', 'Spinal ultrasound', 'Difficult epidural', 'Obstetric anesthesia'], 'conditions': ['Epidural Catheterization']}, 'descriptionModule': {'briefSummary': 'This is a prospective observational study conducted at the University Hospital of Padua. The goal is to identify ultrasound markers that can help predict whether placing an epidural catheter during labor will be difficult. Pregnant women who request epidural analgesia will undergo a quick ultrasound scan of their lower back before the procedure. The study will collect information such as age, weight, height, and spinal anatomy, as well as ultrasound measurements. This information will be compared with how easy or difficult it was to place the epidural. The study does not involve any experimental treatment and uses standard care procedures already in place. There are no additional risks or costs for participants.', 'detailedDescription': 'This is a single-center, prospective observational study aimed at evaluating whether specific ultrasound measurements of spinal structures in pregnant women can predict technical difficulty in placing an epidural catheter during labor analgesia. All procedures performed are part of standard care and are routinely offered in the labor and delivery unit. Patients who consent to participate will undergo a lumbar ultrasound prior to epidural catheter placement. Data will be collected regarding anatomical and clinical characteristics, ultrasound findings, and procedural details. The study will run for two years or until the estimated sample size of 563 patients is reached. The results are intended to identify non-invasive predictors of challenging epidural placement, potentially improving patient safety and resource allocation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of adult pregnant women (≥18 years old) admitted to the Labor and Delivery Unit at the University Hospital of Padua who are candidates for epidural catheter placement for labor analgesia. All participants must provide written informed consent. No specific exclusion criteria apply.', 'healthyVolunteers': False, 'eligibilityCriteria': '-Inclusion Criteria: Pregnant women aged ≥18 years Candidates for epidural catheter placement for labor analgesia Provided written informed consent\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT07056166', 'briefTitle': 'Ultrasound Predictors of Difficulty in Performing Epidural Anesthesia for Labor in Pregnant Patients.', 'organization': {'class': 'OTHER', 'fullName': 'University of Padova'}, 'officialTitle': 'Prospective Observational Study: Ultrasound Predictors of Difficulty in Performing Epidural Anesthesia for Labor in Pregnant Patients.', 'orgStudyIdInfo': {'id': 'AOP3720'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant patients undergoing epidural placement for labor analgesia', 'interventionNames': ['Procedure: epidural catheter', 'Procedure: spine ultrasonography']}], 'interventions': [{'name': 'epidural catheter', 'type': 'PROCEDURE', 'description': 'Epidural catheter placement for labor analgesia', 'armGroupLabels': ['Pregnant patients undergoing epidural placement for labor analgesia']}, {'name': 'spine ultrasonography', 'type': 'PROCEDURE', 'description': 'An ultrasound scan will be performed on the spine to identify anatomical characteristics of potential interest', 'armGroupLabels': ['Pregnant patients undergoing epidural placement for labor analgesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35127', 'city': 'Padua', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro De Cassai, Medical Doctor', 'role': 'CONTACT', 'email': 'alessandro.decassai@aopd.veneto.it', 'phone': '+390498213090'}], 'facility': 'University Hospital of Padua', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}], 'centralContacts': [{'name': 'Alessandro De Cassai, Medical Doctor', 'role': 'CONTACT', 'email': 'alessandro.decassai@aopd.veneto.it', 'phone': '+390498213090'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Padova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alessandro De Cassai', 'investigatorAffiliation': 'University of Padova'}}}}