Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT02237092
Status:
COMPLETED
Last Update Posted:
2019-01-15
First Post:
2014-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Intra-abdominal Pressure to the Level of the Sensory Block at Caesarean Section Under Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ronensonam@gmail.com', 'phone': '011-7-4822-776213', 'title': 'Dr. Alexandr Ronenson', 'organization': 'Tver Regional Perinatal Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'During the operation, an average of 30 minutes', 'description': 'Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure', 'eventGroups': [{'id': 'EG000', 'title': 'Level of Sensory Block => Th4 (Spinal Anesthesia)', 'description': 'Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure', 'otherNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Level of Sensory Block < = Th5 (Spinal Anesthesia)', 'description': 'Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure', 'otherNumAtRisk': 134, 'otherNumAffected': 0, 'seriousNumAtRisk': 134, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Changing the type of anesthesia', 'notes': 'Changing the type of anesthesia to General anesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'General anesthesia'}], 'seriousEvents': [{'term': 'Hypotension', 'notes': 'Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Hypotension'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Level of Intra-abdominal Pressure (IAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intra-abdominal Pressure (IAP) in Pregnant Women', 'description': 'Average IAP in pregnant women'}], 'classes': [{'categories': [{'measurements': [{'value': '15.33', 'spread': '0.17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Before spinal anesthesia, average 10 minutes.', 'description': 'Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, after quiet breathing pregnant at the time of expiration. The data obtained are in inches of water column were translated in millimeters of mercury.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Classification Grade of Intra-abdominal Hypertension (IAH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Physiological Norm', 'description': '(≤11,99 mm Hg)'}, {'id': 'OG001', 'title': 'Grade I', 'description': '(12 - 15.99 mm Hg)'}, {'id': 'OG002', 'title': 'Grade II', 'description': '(16 - 20.99 mm Hg)'}, {'id': 'OG003', 'title': 'Grade III', 'description': '(21 - 25.99 mm Hg)'}], 'classes': [{'categories': [{'measurements': [{'value': '11.60', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '14.11', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '17.43', 'spread': '0.14', 'groupId': 'OG002'}, {'value': '21.56', 'spread': '0.25', 'groupId': 'OG003'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Before spinal anesthesia, average 10 minutes.', 'description': 'Average IAP in pregnant women with different Grade of intra-abdominal hypertension Physiological norm (≤11,99 mm Hg) Grade I (12 - 15.99 mm Hg) Grade II (16 - 20.99 mm Hg) Grade III (21 - 25.99 mm Hg)', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Level of Sensory Blocks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Level of Sensory Block => Th4 (Spinal Anesthesia)', 'description': 'Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia'}, {'id': 'OG001', 'title': 'Level of Sensory Block < = Th5 (Spinal Anesthesia)', 'description': 'Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'After spinal anesthesia, average 20 minutes.', 'description': 'Block level of thoracic vertebrae are reported for pregnant women who had level of sensory block higher than 4 thoracic vertebra and less than 5 thoracic vertebra', 'unitOfMeasure': 'Block level level of thoracic vertebrae', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Obesity and IAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Obesity', 'description': 'BMI \\< = 29.99'}, {'id': 'OG001', 'title': 'Obesity', 'description': 'BMI = \\> 30.00'}], 'classes': [{'categories': [{'measurements': [{'value': '14.61', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '16.06', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Before spinal anesthesia, average 10 minutes.', 'description': 'Effect of obesity on the level of IAP', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Level of IAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Level of Sensory Block => Th4 (Spinal Anesthesia)', 'description': 'Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia'}, {'id': 'OG001', 'title': 'Level of Sensory Block < = Th5 (Spinal Anesthesia)', 'description': 'Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.02', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'After spinal anesthesia, average 20 minutes.', 'description': 'The level of IAP in obstetric patients in the groups with high ( =\\> Th4) and low (\\< = Th5) blocks', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Level of IAP < 16 mm Hg', 'description': 'number of pregnant women with Level of IAP \\< 16 mm Hg'}, {'id': 'OG001', 'title': 'Level of IAP = > 16 mm Hg', 'description': 'number of pregnant women with Level of IAP = \\> 16 mm Hg'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.58', 'ciLowerLimit': '1.05', 'ciUpperLimit': '2.58', 'statisticalMethod': 'NNT', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'After spinal anesthesia, average 20 minutes.', 'unitOfMeasure': 'Number of pregnants with Blocks = > Th4', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Measurement of IAP', 'description': 'The data obtained are in inches of water column were translated in millimeters of mercury.\n\nMeasurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Gestational age 36 - 40 weeks, Singleton pregnancies, Elective caesarean section'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Measurement of IAP', 'description': 'Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration.The data obtained are in inches of water column were translated in millimeters of mercury.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.5', 'spread': '5.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '196', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Pregnant women'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '163.9', 'spread': '7.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '30.8', 'spread': '5.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Abdominal circumference', 'classes': [{'categories': [{'measurements': [{'value': '105.1', 'spread': '10.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Pregnant planned for cesarean section'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-02', 'studyFirstSubmitDate': '2014-09-02', 'resultsFirstSubmitDate': '2014-09-10', 'studyFirstSubmitQcDate': '2014-09-10', 'lastUpdatePostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-09-30', 'studyFirstPostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Level of Intra-abdominal Pressure (IAP)', 'timeFrame': 'Before spinal anesthesia, average 10 minutes.', 'description': 'Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, after quiet breathing pregnant at the time of expiration. The data obtained are in inches of water column were translated in millimeters of mercury.'}, {'measure': 'Classification Grade of Intra-abdominal Hypertension (IAH)', 'timeFrame': 'Before spinal anesthesia, average 10 minutes.', 'description': 'Average IAP in pregnant women with different Grade of intra-abdominal hypertension Physiological norm (≤11,99 mm Hg) Grade I (12 - 15.99 mm Hg) Grade II (16 - 20.99 mm Hg) Grade III (21 - 25.99 mm Hg)'}, {'measure': 'Obesity and IAP', 'timeFrame': 'Before spinal anesthesia, average 10 minutes.', 'description': 'Effect of obesity on the level of IAP'}], 'secondaryOutcomes': [{'measure': 'Level of Sensory Blocks', 'timeFrame': 'After spinal anesthesia, average 20 minutes.', 'description': 'Block level of thoracic vertebrae are reported for pregnant women who had level of sensory block higher than 4 thoracic vertebra and less than 5 thoracic vertebra'}, {'measure': 'The Level of IAP', 'timeFrame': 'After spinal anesthesia, average 20 minutes.', 'description': 'The level of IAP in obstetric patients in the groups with high ( =\\> Th4) and low (\\< = Th5) blocks'}, {'measure': 'Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg', 'timeFrame': 'After spinal anesthesia, average 20 minutes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obstetric Anesthesia Problems', 'High-Risk Pregnancy']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'S. Sitkin, A. Ronenson, J. Savelieva, M. Cherdyntsev. Prediction of high level spinal block in caesarean section. Regional Anesthesia and Pain Medicine. - 2012. - Volume 37. - Sup 1 5. - p. 183.'}, {'type': 'RESULT', 'citation': 'Sitkin, S.; Ronenson, A.; Wagle, S.; Saveleva, J. Effect of intra-abdominal pressure of pregnancy for the development of spinal block for cesarean section: 11AP1-10. European Journal of Anaesthesiology. - 2013 - Volume 30. - Sup 51. - p. 167-168.'}, {'type': 'RESULT', 'citation': 'Sitkin S., Ronenson A.M., Savelieva J.V., Wagle S. Influence of intra-abdominal pressure (iap) and body mass index (bmi) in pregnancy on the development of spinal block for cesarean section. Regional Anesthesia and Pain Medicine, Volume 38, Number 5, Supplement 1 5, September-October. - 2013. - p. 179'}], 'seeAlsoLinks': [{'url': 'http://www.freepatent.ru/images/patents/497/2499554/patent-2499554.pdf', 'label': 'Patent on the research'}]}, 'descriptionModule': {'briefSummary': 'It is known that an increase in intra-abdominal pressure (IAP) causes a decrease in the volume of cerebrospinal fluid in the lumbar and lower thoracic region, which may contribute to the development of more high spinal block.', 'detailedDescription': 'There is a hypothesis, the higher the level of intra-abdominal pressure, the greater the likelihood of developing a high-level (=\\>Th4) sensor block.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age 36 - 40 weeks\n* Singleton pregnancies\n* Elective caesarean section\n\nExclusion Criteria:\n\n* Gestational age \\<= 35 weeks\n* Twins pregnancies\n* Disease the cardiovascular system (hypertension, etc.)\n* Non-elective caesarean section'}, 'identificationModule': {'nctId': 'NCT02237092', 'acronym': 'IAPSB', 'briefTitle': 'Effect of Intra-abdominal Pressure to the Level of the Sensory Block at Caesarean Section Under Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Tver Regional Perinatal Center'}, 'officialTitle': 'Effect of Intra-abdominal Pressure to the Level of the Sensory Block at Caesarean Section Under Spinal Anesthesia', 'orgStudyIdInfo': {'id': 'TR-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Measurement of IAP', 'description': 'The data obtained are in inches of water column were translated in millimeters of mercury.', 'interventionNames': ['Procedure: Measurement of IAP']}], 'interventions': [{'name': 'Measurement of IAP', 'type': 'PROCEDURE', 'description': 'The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration.', 'armGroupLabels': ['Measurement of IAP']}]}, 'contactsLocationsModule': {'locations': [{'city': "Tver'", 'country': 'Russia', 'facility': 'Tver Regional Perinatal Center', 'geoPoint': {'lat': 56.85836, 'lon': 35.90057}}], 'overallOfficials': [{'name': 'Alexandr Ronenson, PhD student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tver Regional Perinatal Center'}, {'name': 'Sergei Sitkin, DMedSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tver State Medical Academy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tver Regional Perinatal Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}