Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT00846651
Status:
COMPLETED
Last Update Posted:
2017-10-16
First Post:
2009-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Spinal Anesthesia Induced Hypotension During Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'svaida@hmc.psu.edu', 'phone': '7175318433', 'title': 'Sonia Vaida', 'organization': 'Penn State Milton S. Hershey Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'technical problems for analysing fetal pH in all newborns'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Colloid, Then Phenylephrine Infusion', 'description': 'colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.', 'otherNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Crystalloid, Then Phenylephrine Infusion', 'description': "Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.", 'otherNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Maternal Hypotension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colloid, Then Phenylephrine Infusion', 'description': 'colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.'}, {'id': 'OG001', 'title': 'Crystalloid, Then Phenylephrine Infusion', 'description': "Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision."}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dosage of Phenylephrine Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colloid, Then Phenylephrine Infusion', 'description': 'colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.'}, {'id': 'OG001', 'title': 'Crystalloid, Then Phenylephrine Infusion', 'description': "Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision."}], 'classes': [{'categories': [{'measurements': [{'value': '1077', 'spread': '541', 'groupId': 'OG000'}, {'value': '1477', 'spread': '591', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby', 'unitOfMeasure': 'mcg of phenylephrine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Maternal Bradycardia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colloid, Then Phenylephrine Infusion', 'description': 'colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.'}, {'id': 'OG001', 'title': 'Crystalloid, Then Phenylephrine Infusion', 'description': "Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision."}], 'classes': [{'categories': [{'measurements': [{'value': '35.1', 'groupId': 'OG000'}, {'value': '45.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fetal Cord Blood pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colloid, Then Phenylephrine Infusion', 'description': 'colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.\n\nColloid administration: The patients received 0.5 L colloid solution (hydroxyethylstarch 6%) or 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.\n\nphenylephrine infusion: A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.'}, {'id': 'OG001', 'title': 'Crystalloid, Then Phenylephrine Infusion', 'description': "crystalloid administration; The patients received 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min prior to spinal anesthesia for cesarean section. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.\n\nCrystalloid administration: The patients received 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.\n\nphenylephrine infusion: A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision."}], 'timeFrame': 'delivery of the baby', 'reportingStatus': 'POSTED', 'populationDescription': 'Physician policy changes resulted in blood gas values not being ordered and thus data was not available for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'APGAR Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colloid, Then Phenylephrine Infusion', 'description': 'colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.'}, {'id': 'OG001', 'title': 'Crystalloid, Then Phenylephrine Infusion', 'description': "Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision."}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '10'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Apgar scores were assessed at 1 amd 5 min after delivery of the baby', 'description': 'The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10 with higher scores being better than lower scores. The five criteria are summarized using words chosen to form an acronym (Appearance, Pulse, Grimace, Activity, Respiration).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Maternal Nausea and Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colloid, Then Phenylephrine Infusion', 'description': 'colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.'}, {'id': 'OG001', 'title': 'Crystalloid, Then Phenylephrine Infusion', 'description': "Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision."}], 'classes': [{'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}, {'value': '18.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Colloid, Then Phenylephrine Infusion', 'description': 'colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.'}, {'id': 'FG001', 'title': 'Crystalloid, Then Phenylephrine Infusion', 'description': "Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'We applied for an IRB approval for 90 patients. The power analysis indicated that a minimum of 37 subjects for each group was needed. To allow for potential dropouts, we applied for 45 patient in each group. (total of 9O patients)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Colloid, Then Phenylephrine Infusion', 'description': 'colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.'}, {'id': 'BG001', 'title': 'Crystalloid, Then Phenylephrine Infusion', 'description': "Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.9', 'spread': '5.1', 'groupId': 'BG000'}, {'value': '28.3', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '26.6', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-14', 'studyFirstSubmitDate': '2009-02-18', 'resultsFirstSubmitDate': '2013-02-04', 'studyFirstSubmitQcDate': '2009-02-18', 'lastUpdatePostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-05-29', 'studyFirstPostDateStruct': {'date': '2009-02-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Maternal Hypotension', 'timeFrame': 'participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby'}], 'secondaryOutcomes': [{'measure': 'Dosage of Phenylephrine Used', 'timeFrame': 'participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby'}, {'measure': 'Incidence of Maternal Bradycardia', 'timeFrame': 'participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby'}, {'measure': 'Fetal Cord Blood pH', 'timeFrame': 'delivery of the baby'}, {'measure': 'APGAR Scores', 'timeFrame': 'Apgar scores were assessed at 1 amd 5 min after delivery of the baby', 'description': 'The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10 with higher scores being better than lower scores. The five criteria are summarized using words chosen to form an acronym (Appearance, Pulse, Grimace, Activity, Respiration).'}, {'measure': 'Incidence of Maternal Nausea and Vomiting', 'timeFrame': 'participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['spinal anesthesia', 'cesarean section'], 'conditions': ['Hypotension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections.', 'detailedDescription': "Many women experience low blood pressure after spinal anesthesia for Cesarean section. This low blood pressure may result in nausea, vomiting dizziness and impairment of uterine blood flow.The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections. In both methods, we will attempt to prevent low blood pressure using phenylephrine infusion that has been shown to be effective in recent research. In addition to receiving phenylephrine one group of patients will receive standard salt solution (Ringer's lactate solution), while the other group will receive a different, intravenous fluid called hydroxyethylstarch."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status I and II\n* Elective cesarean section\n* Weight 50-120 kg, Height 150-180 cm\n* Normal singleton pregnancy\n* Beyond 36 weeks gestation\n* No known fetal abnormalities\n* Ages 18-35\n\nExclusion Criteria:\n\n* Contraindications to spinal anesthesia\n* Multiple gestation, placenta previa, accreta\n* Pregnancy induced hypertension or preeclampsia\n* Diabetes mellitus, cardiovascular diseases\n* Coagulopathy\n* Spinal cord abnormalities, spinal surgery, or preexisting neurological dysfunction\n* Baseline HR \\<65\n* Failed spinal anesthesia/inadequate sensory block for surgery\n* History of abnormal bleeding\n* History of adverse reactions to hydroxyethylstarch'}, 'identificationModule': {'nctId': 'NCT00846651', 'briefTitle': 'Spinal Anesthesia Induced Hypotension During Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Comparison of Phenylephrine Infusion With Colloids vs. Crystalloids for Reduction of Spinal-induced Hypotension During Cesarean Section', 'orgStudyIdInfo': {'id': 'IRB #29595'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'colloid, then phenylephrine infusion', 'description': 'colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.', 'interventionNames': ['Other: Colloid administration', 'Drug: phenylephrine infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'crystalloid, then phenylephrine infusion', 'description': "crystalloid administration; The patients received 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min prior to spinal anesthesia for cesarean section. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.", 'interventionNames': ['Other: Crystalloid administration', 'Drug: phenylephrine infusion']}], 'interventions': [{'name': 'Colloid administration', 'type': 'OTHER', 'description': 'The patients received 0.5 L colloid solution (hydroxyethylstarch 6%) or 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.', 'armGroupLabels': ['colloid, then phenylephrine infusion']}, {'name': 'Crystalloid administration', 'type': 'OTHER', 'description': 'The patients received 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.', 'armGroupLabels': ['crystalloid, then phenylephrine infusion']}, {'name': 'phenylephrine infusion', 'type': 'DRUG', 'description': 'A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.', 'armGroupLabels': ['colloid, then phenylephrine infusion', 'crystalloid, then phenylephrine infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'PennState Hershey Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D, Vice chair for research, Anesthesia Department', 'investigatorFullName': 'Sonia Vaida', 'investigatorAffiliation': 'Penn State University'}}}}