Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-27 @ 3:09 PM
Study NCT ID:
NCT05260333
Status:
COMPLETED
Last Update Posted:
2023-11-27
First Post:
2022-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sound Check-Correlation Between Transperineal and Digital Cervical Exam in 3rd Trimester Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'leah.antoniewicz@bcm.edu', 'phone': '832-8267458', 'title': 'Dr. Leah Antoniewicz, MD-PI', 'organization': 'Baylor College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Transperineal Ultrasound Cervical Exam', 'description': 'Patients will undergo transperineal cervical exam via Butterfly iQ ultrasound.\n\nButterfly iQ transperineal ultrasound exam: Transperineal ultrasound', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Digital (Manual) Cervical Exam', 'description': "Patients will undergo traditional digital cervical exam via examiner's fingers.\n\nButterfly iQ transperineal ultrasound exam: Transperineal ultrasound", 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Correlation of Cervical Dilation Via Butterfly iQ Pocket Ultrasound in Centimeters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transperineal Ultrasound Cervical Exam Dilation', 'description': 'Diameter of cervix in centimeters'}, {'id': 'OG001', 'title': 'Digital (Manual) Cervical Exam Dilation', 'description': 'Diameter of cervix in centimeters'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'analyses': [{'pValue': '.0001', 'groupIds': ['OG000'], 'paramType': 'correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '1 day', 'description': 'Dilation was measured on the day of the exam in centimeters. A correlation coefficient was then calculated to determine the relationship between the two exams.', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The patients served as their own control.'}, {'type': 'SECONDARY', 'title': 'Discomfort Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transperineal Ultrasound Cervical Exam Followed by Digital (Manual)', 'description': "Patients will undergo transperineal cervical exam via Butterfly iQ ultrasound. Then patients will undergo traditional digital cervical exam via examiner's fingers."}], 'classes': [{'title': 'Transperineal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Digital', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 day', 'description': '3-point Likert scale (0 = no discomfort, 3 = maximum) discomfort on questionnaire.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Preference for 1 Exam Over the Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transperineal Ultrasound Cervical Exam Followed by Digital (Manual)', 'description': 'Patients will undergo transperineal cervical exam via Butterfly iQ ultrasound followed by digital cervical exam.'}], 'classes': [{'title': 'Preferred TPUS', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Preferred Digital', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day', 'description': 'Patients were asked if they had a preference and circled yes or no on questionnaire', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transperineal Ultrasound and Digital Cervical Exam', 'description': 'Patients will undergo transperineal cervical exam via Butterfly iQ ultrasound followed by a traditional digital cervical exam.\n\nButterfly iQ transperineal ultrasound exam: Transperineal ultrasound'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'The patients acted as there own control. 30 patients were enrolled, but a total of 60 exams (1 TPUS and 1 SVE) were performed.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'Transperineal Ultrasound', 'comment': 'The patients acted as there own control. 30 patients were enrolled, but a total of 60 exams (1 TPUS and 1 SVE) were performed.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'Digital Cervical Exam', 'comment': 'The patients acted as there own control. 30 patients were enrolled, but a total of 60 exams (1 TPUS and 1 SVE) were performed.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'comment': 'The patients acted as there own control. 30 patients were enrolled, but a total of 60 exams (1 TPUS and 1 SVE) were performed.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The first patient was enrolled in April of 2022, and last patient was seen in July of 2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Transperineal Ultrasound Cervical Exam and Digital (Manual) Cervical Exam', 'description': "Patients will undergo transperineal cervical exam via Butterfly iQ ultrasound and then undergo traditional digital cervical exam via examiner's fingers..\n\nButterfly iQ transperineal ultrasound exam: Transperineal ultrasound"}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Collected from chart', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cervical Dilation', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-09', 'size': 138134, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-25T16:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The investigator will not know the digital cervical exam value.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Patients will have a transperineal ultrasound followed by a traditional digital cervical exam.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-24', 'studyFirstSubmitDate': '2022-02-16', 'resultsFirstSubmitDate': '2023-05-14', 'studyFirstSubmitQcDate': '2022-02-27', 'lastUpdatePostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-24', 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of Cervical Dilation Via Butterfly iQ Pocket Ultrasound in Centimeters', 'timeFrame': '1 day', 'description': 'Dilation was measured on the day of the exam in centimeters. A correlation coefficient was then calculated to determine the relationship between the two exams.'}], 'secondaryOutcomes': [{'measure': 'Discomfort Scale', 'timeFrame': '1 day', 'description': '3-point Likert scale (0 = no discomfort, 3 = maximum) discomfort on questionnaire.'}, {'measure': 'Preference for 1 Exam Over the Other', 'timeFrame': '1 day', 'description': 'Patients were asked if they had a preference and circled yes or no on questionnaire'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['transperineal', 'ultrasound', 'cervix', 'labor'], 'conditions': ['Cervix; Pregnancy']}, 'referencesModule': {'references': [{'pmid': '7724106', 'type': 'BACKGROUND', 'citation': 'Richey SD, Ramin KD, Roberts SW, Ramin SM, Cox SM, Twickler DM. The correlation between transperineal sonography and digital examination in the evaluation of the third-trimester cervix. Obstet Gynecol. 1995 May;85(5 Pt 1):745-8. doi: 10.1016/0029-7844(95)00027-o.'}, {'pmid': '2277401', 'type': 'BACKGROUND', 'citation': 'Mahony BS, Nyberg DA, Luthy DA, Hirsch JH, Hickok DE, Petty CN. Translabial ultrasound of the third-trimester uterine cervix. Correlation with digital examination. J Ultrasound Med. 1990 Dec;9(12):717-23. doi: 10.7863/jum.1990.9.12.717.'}, {'pmid': '8293582', 'type': 'BACKGROUND', 'citation': 'Newton ER. Chorioamnionitis and intraamniotic infection. Clin Obstet Gynecol. 1993 Dec;36(4):795-808. doi: 10.1097/00003081-199312000-00004.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to compare the accuracy of the Butterfly iQ pocket ultrasound with the digital cervical examination in the third trimester cervix. The secondary aim of this study is to compare discomfort or the two cervical exam methods and determine if patients have a preference for one over the other.', 'detailedDescription': 'Patients in the 3rd trimester that require a digital cervical exam (DCE) for assessment of labor will be approached. After informed consent is obtained, one of two study investigators will perform a transperineal ultrasound (TPUS) using the glove-covered Butterfly iQ+ probe. The Butterfly iQ+ does not have a transperineal probe or setting, therefore, the "bladder" preset setting will be used. The "bladder" setting has been predetermined to provide the best cervical images. This pocket ultrasound is FDA-approved and is the standard of care for point of care ultrasounds in many institutions and is already used in our department. The TPUS will be performed by 1 of the 2 investigators with digital calipers. There will be 3 measurements: dilation, effacement, and station. The dilation measurements with be made from the inside margins of the cervix . Effacement will be measured by marking the thinnest and most easily imaged lip of the cervix. Zero station will be assumed to be 5 cm above the perineum, with distances from 6-10 cm corresponding to -1 to -5 station clinically. An independent, blinded examiner will then perform a traditional digital cervical exam, which will be recorded in EPIC. The study investigators will be blinded to the DCE measurement until the end of the study. The patient will act as their own control. Additionally, the investigators will collect EGA, race, ethnicity, age, BMI, and indication for assessment of the cervix.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women in the third trimester presenting for assessment of labor or admitted for labor and delivery.\n\nExclusion Criteria:\n\n* Second trimester (less than 28 weeks)\n* BMI\\>50\n* Does not wish to participate'}, 'identificationModule': {'nctId': 'NCT05260333', 'briefTitle': 'Sound Check-Correlation Between Transperineal and Digital Cervical Exam in 3rd Trimester Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Use of a Pocket-device Point-of-care Ultrasound to Assess Cervical Dilation in Labor: Correlation and Patient Experience', 'orgStudyIdInfo': {'id': 'H-50937'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transperineal ultrasound cervical exam followed by Digital (manual) cervical exam', 'description': "Patients will undergo transperineal cervical exam via Butterfly iQ ultrasound. Patients will then undergo traditional digital cervical exam via examiner's fingers.", 'interventionNames': ['Device: Butterfly iQ transperineal ultrasound exam']}], 'interventions': [{'name': 'Butterfly iQ transperineal ultrasound exam', 'type': 'DEVICE', 'description': 'Transperineal ultrasound', 'armGroupLabels': ['Transperineal ultrasound cervical exam followed by Digital (manual) cervical exam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital Pavilion for Women", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Leah W Antoniewicz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Leah Antoniewicz', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}