Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2026-02-21 @ 11:17 PM
Study NCT ID:
NCT02865057
Status:
COMPLETED
Last Update Posted:
2017-11-13
First Post:
2016-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Fetal Position in Active Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-08', 'studyFirstSubmitDate': '2016-08-03', 'studyFirstSubmitQcDate': '2016-08-09', 'lastUpdatePostDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assessing fetal position', 'timeFrame': 'Immediate', 'description': "Categorical variables will be expressed as frequencies and percentages. Continuous variables will be expressed as means and standard deviations and/or medians and ranges. Demographic characteristics will be assessed using chi-square test and Fischer's Exact test for categorical variables. To examine improvement in the number of correct physical exams from baseline to post-intervention a repeated measures t-test or Wilcoxon signed rank test will be performed. An independent measures t-test or Mann-Whitney U test will be performed to compare the number of correct physical exams between resident groups. Other pertinent statistical tests will be utilized as needed to account for group differences and control for variables of interest."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Education']}, 'descriptionModule': {'briefSummary': 'Vaginal exams are used routinely in labor to assess cervical dilation and position of the baby (facing anterior, facing to the right or left side, facing towards maternal spine). This technique has a widely variable accuracy rate (24.0-85.6%). Ultrasound has been used to help confirm or correct the vaginal assessment by obstetricians, but has not been used to assess the utility of immediate feedback to improve the accuracy of vaginal assessment by physicians in training. The investigators plan to use ultrasound assessment to determine if this education is effective in increasing accuracy in the resident population.', 'detailedDescription': 'Residents will be informed of the study through an education session (as a group) and then be consented individually. Each resident will complete 15 baseline exams, 20 exams with immediate ultrasound confirmation, and 15 exams for post-test baseline. Exams will take place periodically throughout the year. Both 3rd and 4th year residents will be assessed during the same time period by the MFM fellows. Ultrasounds will follow the vaginal exam as closely as possible to prepare for delivery. A picture of the fetal position (with no name or MRN) for documentation to be taken during the SOC ultrasound and kept in the research chart for the resident.\n\nIn training feedback is not always standard. This teaching tool, consistent and standard feedback with regard to the correlation between vaginal exam and ultrasound, would allow the resident to learn to assess fetal position more accurately.\n\nInformation from the maternal chart (history and delivery information) will be collected as de identified. Data will be recorded on the data collection sheet which is labeled with a code number linking the resident participant only.\n\nData collected from the residents will be assigned a random Code numbers used to link the subject to their data.\n\nCode and identifiers will be kept separate. Paper copies will be kept in a locked cabinet, in a locked office, in a locked suite.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '26 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '3rd and 4th year Ob, Gyn Residents', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physicians in obstetrics training -\n\nExclusion Criteria:\n\n* Physicians outside of obstetrics training.'}, 'identificationModule': {'nctId': 'NCT02865057', 'acronym': 'U/S', 'briefTitle': 'Assessment of Fetal Position in Active Labor', 'organization': {'class': 'OTHER', 'fullName': 'St. Louis University'}, 'officialTitle': 'Ultrasound Examination as a Teaching Tool for Vaginal Exam Assessment of Fetal Position in Active Labor', 'orgStudyIdInfo': {'id': '26057'}}, 'armsInterventionsModule': {'armGroups': [{'label': '3rd year Residents', 'description': '3rd year Ob, Gyn Residents', 'interventionNames': ['Procedure: Vaginal assessment']}, {'label': '4th Year Residents', 'description': '4th year Ob, Gyn Residents', 'interventionNames': ['Procedure: Vaginal assessment']}], 'interventions': [{'name': 'Vaginal assessment', 'type': 'PROCEDURE', 'description': 'Vaginal assessment of position prior to delivery', 'armGroupLabels': ['3rd year Residents', '4th Year Residents']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jennifer Goldkamp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Louis University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Louis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MFM Fellow', 'investigatorFullName': 'Jennifer Goldkamp, MD', 'investigatorAffiliation': 'St. Louis University'}}}}