Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-29 @ 8:07 AM
Study NCT ID:
NCT00377832
Status:
TERMINATED
Last Update Posted:
2013-09-16
First Post:
2006-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005334', 'term': 'Fever'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dwskupsk@med.cornell.edu', 'phone': '718-670-1495', 'title': 'Daniel W. Skupski, MD', 'organization': 'Weill Cornell Medical College'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Poor recruitment and lack of funding led to early termination of the trial'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'No Medication', 'description': 'In labor, fever is identified, consent and randomization occurs, then no medication is given.', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Acetaminophen 975 mg Once', 'description': 'In labor, fever is identified, consent and randomization occurs, then acetaminophen is given.', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maternal Body Temperature 90 Minutes After Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'In Labor With a Fever Will Give no Medication'}, {'id': 'OG001', 'title': 'In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '37.3', 'upperLimit': '38.5'}, {'value': '37.4', 'groupId': 'OG001', 'lowerLimit': '37.1', 'upperLimit': '37.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '90 minutes', 'description': 'Fever in labor is identified,consenting and randomization occurs, either acetaminophen is given or no medication is given, then 90 minutes later maternal temperature is recorded.', 'unitOfMeasure': 'degrees centigrade', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Baseline Fetal Heart Rate (FHR) After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Medication'}, {'id': 'OG001', 'title': 'Acetaminophen 975 mg Once'}], 'classes': [{'categories': [{'measurements': [{'value': '167.6', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '152.5', 'spread': '9.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 minutes', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Temperature Difference Before and After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'In Labor With a Fever Will Give no Medication'}, {'id': 'OG001', 'title': 'In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '1.6'}, {'value': '-0.15', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '0.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '90 minutes', 'description': 'Maternal temperature difference before randomization and 90 minutes after randomization in degrees Centigrade', 'unitOfMeasure': 'degrees Centigrade', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Cesarean Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'In Labor With a Fever Will Give no Medication'}, {'id': 'OG001', 'title': 'In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Labor--up to 24 hours', 'description': 'Rate of cesarean delivery', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Determination of Non-reassuring Fetal Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'In Labor With a Fever Will Give no Medication'}, {'id': 'OG001', 'title': 'In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Labor--up to 24 hours', 'description': 'Non-reassuring fetal status is when cesarean delivery or operative vaginal delivery (forceps or vacuum) are performed for fetal heart rate abnormalities.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Subsequent Development of Maternal Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'In Labor With a Fever Will Give no Medication'}, {'id': 'OG001', 'title': 'In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Labor--up to 24 hours', 'description': 'Rate of subsequent development of maternal fever, i.e., the number of participants who developed fever.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Diagnosis of Clinical Chorioamnionitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'In Labor With a Fever Will Get no Medication'}, {'id': 'OG001', 'title': 'In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Labor--up to 24 hours', 'description': 'Rate of diagnosis of clinical chorioamnionitis, i.e., the number of participants who developed chorioamnionitis.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Neonatal Sepsis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'In Labor With a Fever Will Give no Medication'}, {'id': 'OG001', 'title': 'In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days', 'description': 'the number of participants who developed neonatal sepsis', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'In Labor With a Fever Will Give no Medication'}, {'id': 'FG001', 'title': 'In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Dates of recruitment 9/2006 until 12/2010 13 patients recruited No funding', 'preAssignmentDetails': 'All participants included in assigned groups'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'No Medication'}, {'id': 'BG001', 'title': 'Acetaminophen 975 mg Once'}, {'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': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', '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': '26.4', 'spread': '3.4', 'groupId': 'BG000'}, {'value': '26.1', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '26.3', 'spread': '3.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', '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': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Poor recruitment and lack of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-05', 'studyFirstSubmitDate': '2006-09-14', 'resultsFirstSubmitDate': '2010-12-22', 'studyFirstSubmitQcDate': '2006-09-14', 'lastUpdatePostDateStruct': {'date': '2013-09-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-05', 'studyFirstPostDateStruct': {'date': '2006-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal Body Temperature 90 Minutes After Randomization', 'timeFrame': '90 minutes', 'description': 'Fever in labor is identified,consenting and randomization occurs, either acetaminophen is given or no medication is given, then 90 minutes later maternal temperature is recorded.'}, {'measure': 'Baseline Fetal Heart Rate (FHR) After Treatment', 'timeFrame': '90 minutes'}], 'secondaryOutcomes': [{'measure': 'Temperature Difference Before and After Treatment', 'timeFrame': '90 minutes', 'description': 'Maternal temperature difference before randomization and 90 minutes after randomization in degrees Centigrade'}, {'measure': 'Rate of Cesarean Delivery', 'timeFrame': 'Labor--up to 24 hours', 'description': 'Rate of cesarean delivery'}, {'measure': 'Rate of Determination of Non-reassuring Fetal Status', 'timeFrame': 'Labor--up to 24 hours', 'description': 'Non-reassuring fetal status is when cesarean delivery or operative vaginal delivery (forceps or vacuum) are performed for fetal heart rate abnormalities.'}, {'measure': 'Rate of Subsequent Development of Maternal Fever', 'timeFrame': 'Labor--up to 24 hours', 'description': 'Rate of subsequent development of maternal fever, i.e., the number of participants who developed fever.'}, {'measure': 'Rate of Diagnosis of Clinical Chorioamnionitis', 'timeFrame': 'Labor--up to 24 hours', 'description': 'Rate of diagnosis of clinical chorioamnionitis, i.e., the number of participants who developed chorioamnionitis.'}, {'measure': 'Rate of Neonatal Sepsis', 'timeFrame': '7 days', 'description': 'the number of participants who developed neonatal sepsis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fetal tachycardia', 'Fever in labor', 'Acetaminophen', 'Non reassuring fetal status'], 'conditions': ['Fever', 'Heart Rate, Fetal (FHR)']}, 'descriptionModule': {'briefSummary': 'The most common cause of fetal tachycardia is maternal fever. Fetal tachycardia often precedes the maternal fever, and fetal tachycardia confounds the interpretation of electronic fetal monitoring (EFM), increasing the rate of cesarean delivery for non-reassuring fetal status (NRFS). Our hypothesis is that treatment of fetal tachycardia with acetaminophen will significantly lower maternal body temperature and significantly lower baseline fetal heart rate (FHR). The importance is that interpretation of EFM will improve, thus allowing for a decrease in cesarean delivery for NRFS.', 'detailedDescription': 'This trial is a randomized, non-placebo controlled, assessment of whether acetaminophen can lower maternal temperature and baseline fetal heart rate in laboring patients with fetal tachycardia.\n\nTerm singleton cephalic pregnancies in active phase labor (spontaneous or induced) with fetal tachycardia will be recruited. Patient will be excluded for:\n\n* Exclusion criteria (prior to randomization):\n* Acetaminophen allergy\n* Clinical chorioamnionitis\n* Maternal fever\n* Non-reassuring fetal status (NRFS), which is the designation for fetal heart rate abnormalities requiring cesarean delivery\n* Previous cesarean delivery\n* Multifetal gestation\n* Breech presentation\n* Known fetal anomaly\n* Known contraindication to vaginal delivery\n\nPrimary outcome measures are:\n\n1. Maternal body temperature (oral) 90 minutes after treatment\n2. Baseline FHR\n\nSecondary outcome measures are:\n\n1. Temperature difference before and after treatment\n2. Rate of cesarean delivery\n3. Rate of determination of NRFS\n4. Rate of subsequent development of maternal fever\n5. Rate of diagnosis of clinical chorioamnionitis\n6. Rate of neonatal sepsis\n\nPower calculation Internal data collection at our institution of 53 patients showed a mean decrease in temperature of patients in labor with fever receiving acetaminophen is 0.3 degrees C measured an average (mean) of 90 minutes after administration of acetaminophen. Mean oral temperature before acetaminophen was 38.32, SD 0.33. Mean oral temperature after acetaminophen was 38.03, SD 0.85.\n\nSample size calculation shows that 27 patients are needed in each group to show significant difference using alpha 5% and beta 50%.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Term pregnancy\n* Singleton pregnancy\n* Pregnancy with cephalic presentation\n* Pregnancy in active phase labor\n* Fetal tachycardia\n\nExclusion Criteria:\n\n* Acetaminophen allergy\n* Clinical chorioamnionitis\n* Maternal fever\n* Non-reassuring fetal status or fetal heart rate abnormalities requiring cesarean delivery\n* Previous cesarean delivery\n* Multifetal gestation\n* Breech presentation\n* Known fetal anomaly\n* Known contraindication to vaginal delivery'}, 'identificationModule': {'nctId': 'NCT00377832', 'briefTitle': 'Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial', 'orgStudyIdInfo': {'id': '0605008549'}, 'secondaryIdInfos': [{'id': '4730406', 'type': 'OTHER', 'domain': 'New York Hospital Queens IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1'}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Acetaminophen 975 mg once', 'interventionNames': ['Drug: Acetaminophen 975 mg']}], 'interventions': [{'name': 'Acetaminophen 975 mg', 'type': 'DRUG', 'otherNames': ['Tylenol'], 'description': 'Acetaminophen 975 mg by mouth once only', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11355', 'city': 'Flushing', 'state': 'New York', 'country': 'United States', 'facility': 'New York Hospital Medical Center of Queens', 'geoPoint': {'lat': 40.76538, 'lon': -73.81736}}], 'overallOfficials': [{'name': 'Daniel W Skupski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University, New York Hospital Medical Center of Queens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}