Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2025-12-28 @ 10:05 PM
Study NCT ID:
NCT01280357
Status:
COMPLETED
Last Update Posted:
2013-03-21
First Post:
2011-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Accuracy and Reliability of Fetal Heart Rate and Uterine Contraction Monitoring Method
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000026', 'term': 'Abortion, Habitual'}], 'ancestors': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ianhow@monicahealthcare.com', 'phone': '+44 (0)115912', 'title': 'Ian How', 'phoneExt': '4540', 'organization': 'Monica Healthcare Ltd'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was monitored for the full length of the clinical trial, 6 months in total', 'eventGroups': [{'id': 'EG000', 'title': 'Philips 50XM,', 'description': 'Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the Philips 50XM', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Monica AN24', 'description': 'Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the Philips 50XM', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Continue monitoring with the Philips 50XM and disconnect the Monica AN24 monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.61', 'groupId': 'OG000', 'lowerLimit': '93.91', 'upperLimit': '99.93'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'between 35 mins & 15hrs during first & second stage labor', 'description': 'During labor and delivery uterine contractions were measured between the Monica AN24 \\& the philips 50XM, the waveforms of the two devices were measured to see the percentage of time they were in agreement', 'unitOfMeasure': 'Positive Percentage Agreement (PPA)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the remaining 34 participants in the clinical trials.The data was collected in the following manner.\n\n31 participants were used in FDA 6 way trial for Fetal Heart Rate (FHR) and Uterine Activity (UA) 2 participants were used in a 3 way trial for FHR\n\n1 participant was used in a 3 way trial for UA Equates to 33 files for FHR \\& 32 files for UA'}, {'type': 'PRIMARY', 'title': 'The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'all participants that had fetal heart rate measured with the Monica AN24 \\& the Philips 50XM'}], 'classes': [{'categories': [{'measurements': [{'value': '84.85', 'groupId': 'OG000', 'lowerLimit': '73.84', 'upperLimit': '88.89'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour', 'description': 'During Labor \\& delivery, fetal heart rate was measured between the Monica AN24 \\& the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.', 'unitOfMeasure': 'Positive percantage agreement (PPA)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the remaining 34 participants in the clinical trials.The data was collected in the following manner.\n\n31 participants were used in a FDA 6 way trial for Fetal Heart Rate (FHR)and Uterine Activity (UA) 2 participants were uesd in a 3 way trial for FHR\n\n1 participant was used in a 3 way trial for UA Equates to 33 files for FHR \\& 32 files for UA'}, {'type': 'PRIMARY', 'title': 'The Mean Positive Percentage Agreement (PPA) for Maternal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'all participants that had maternal heart rate measured with the Monica AN24 \\& the Philips 50XM'}], 'classes': [{'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '91.3', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour', 'description': 'During Labor \\& delivery, maternal heart rate was measured between the Monica AN24 \\& the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.', 'unitOfMeasure': 'Positive percantage agreement (PPA)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the remaining 34 participants in the clinical trials.The data was collected in the following manner.\n\n31 participants were used in a FDA 6 way trial for Fetal Heart Rate (FHR)and Uterine Activity (UA) 2 participants were uesd in a 3 way trial for FHR\n\n1 participant was used in a 3 way trial for UA Equates to 33 files for FHR \\& 32 files for UA'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'during labor \\& delivery fetal heart rate, maternal heart rate and uterine contractions were monitored simultaneously by the Monia AN24 \\& the Philips 50XM'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Excluded no internal monitoring', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'IInsufficient data/No data supplied', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'Study was from Feb 2010 to Sept 2010 in a clinical setting at Queens Hospital Centre 82 - 68 164th Street Jamaica New York 11432', 'preAssignmentDetails': 'For all participants if there is any issue or exclusion from monitoring with the Monica AN24, fetal monitoring should continue using the Philips 50xm device'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Monitor With the Philips 50XM, Remove Monica AN24', 'description': 'Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the predicate Tocco device'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-20', 'studyFirstSubmitDate': '2011-01-19', 'resultsFirstSubmitDate': '2011-08-11', 'studyFirstSubmitQcDate': '2011-01-19', 'lastUpdatePostDateStruct': {'date': '2013-03-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-20', 'studyFirstPostDateStruct': {'date': '2011-01-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM', 'timeFrame': 'during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour', 'description': 'During Labor \\& delivery, fetal heart rate was measured between the Monica AN24 \\& the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.'}, {'measure': 'The Mean Positive Percentage Agreement (PPA) for Maternal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM', 'timeFrame': 'during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour', 'description': 'During Labor \\& delivery, maternal heart rate was measured between the Monica AN24 \\& the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.'}], 'secondaryOutcomes': [{'measure': 'The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM', 'timeFrame': 'between 35 mins & 15hrs during first & second stage labor', 'description': 'During labor and delivery uterine contractions were measured between the Monica AN24 \\& the philips 50XM, the waveforms of the two devices were measured to see the percentage of time they were in agreement'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fetal Heart Rate (FHR)', 'Uterine Activity (UA)', 'Labor & Delivery'], 'conditions': ['Pregnancy; Habitual Aborter', 'Weeks of Gestation 37 or More']}, 'descriptionModule': {'briefSummary': 'Clinical Investigation Protocol for a study designed to determine the equivalence of the Monica AN24 monitor to Philips 50XM for fetal heart rate (FHR) and uterine contraction (UC) monitoring during labor. The study will be carried out on subjects in the first and second stages of labor.', 'detailedDescription': 'The study is a prospective, randomized, single-center observational study designed to compare the Fetal Heart Rate (FHR) and Uterine Activity (UA) output data obtained by the Monica AN24 monitor during the first and second stages of labor to those generated by existing FDA-approved devices.Patients were enrolled at the facility but the patient details were removed from the results in order that the data could be randomized for the statistical analysis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant, age 15-40\n* Term gestation (\\>36 completed weeks)\n* Singleton fetus\n* Active labor\n* Vertex presentation\n* Requiring internal monitoring\n\nExclusion Criteria:\n\n* Clinical contraindication for Intra Uterine Pressure Catheter\n* Major fetal malformation'}, 'identificationModule': {'nctId': 'NCT01280357', 'briefTitle': 'Accuracy and Reliability of Fetal Heart Rate and Uterine Contraction Monitoring Method', 'organization': {'class': 'INDUSTRY', 'fullName': 'Monica Healthcare Ltd'}, 'officialTitle': 'Study to Determine Substantial Equivalence of Electrohysterography (EHG) Monitoring to Tocodynanometer Monitoring', 'orgStudyIdInfo': {'id': 'MHL101801'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Monitor Philips 50XM (K954351)', 'description': 'CTG Fetal Monitor If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM', 'interventionNames': ['Device: Philips 50XM']}, {'type': 'EXPERIMENTAL', 'label': 'Monica AN24 (K101801)', 'description': 'EHG Fetal Monitor', 'interventionNames': ['Device: Monica AN24 (K101081)']}], 'interventions': [{'name': 'Monica AN24 (K101081)', 'type': 'DEVICE', 'otherNames': ['Philips Series 50XM (K954351)'], 'description': 'If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM', 'armGroupLabels': ['Monica AN24 (K101801)']}, {'name': 'Philips 50XM', 'type': 'DEVICE', 'description': 'If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM', 'armGroupLabels': ['Monitor Philips 50XM (K954351)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11432', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Queens Hospital Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Wayne Cohen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Queens Hospital Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monica Healthcare Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}