Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2026-04-22 @ 10:07 PM
Study NCT ID:
NCT02836561
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2016-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contraceptive Choice at the Time of Uterine Evacuation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 234}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-17', 'studyFirstSubmitDate': '2016-06-17', 'studyFirstSubmitQcDate': '2016-07-14', 'lastUpdatePostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge that LARC can start at uterine evacuation: Percentage of women who report that LARC methods are available to start at the time of uterine evacuation, as assessed on a questionnaire created for this study', 'timeFrame': 'Day 1: Questionnaire administered prior to the information session', 'description': 'Percentage of women who know that the implant and IUD are available to start at the time of uterine evacuation, as assessed on a questionnaire created for this study. Compared between those who receive the pre-visit information (intervention group) and those who do not receive this information (control group)'}], 'secondaryOutcomes': [{'measure': 'Intervention utility: Percentage of women who report that receiving information about contraception before their appointment was either very useful or somewhat useful, as assessed on a 4-point scale on a questionnaire created for this study', 'timeFrame': 'Day 1: Questionnaire administered prior to information session', 'description': 'Percentage of women who who report that receiving information about contraception before their appointment was either very useful or somewhat useful, as assessed on a 4-point scale on a questionnaire created for this study. Compared between those who received pre-visit information about contraception (intervention group) and those who did not (control group)'}, {'measure': 'General LARC knowledge: Percentage of women with a high score (cutpoint to be determined) on a 10-question LARC knowledge scale developed for this study', 'timeFrame': 'Day 1: Questionnaire administered prior to information session', 'description': 'Percentage of women with a high score (cutpoint to be determined) on a 10-question LARC knowledge scale developed for this study. Compared between those who received the pre-visit information about contraception (intervention group) and those who did not (control group)'}, {'measure': 'Intent to use LARC: Percentage of women who report a LARC method as their preferred method of birth control, as assessed on a questionnaire created for this study', 'timeFrame': 'Day 1: Questionnaire administered prior to information session', 'description': 'Percentage of women who report a LARC method as their preferred method of birth control, as assessed on a questionnaire created for this study. Compared between those who received the pre-visit information about contraception (intervention group) and those who did not (control group)'}, {'measure': 'LARC stage of change: Percentage of women who report being somewhat or very interested in starting a LARC method, as assessed on a 4-point scale on a questionnaire created for this study', 'timeFrame': 'Day 1: Questionnaire administered prior to information session', 'description': 'Percentage of women who report being somewhat or very interested in starting an implant or IUD, as assessed on a 4-point scale on a questionnaire created for this study. Compared between those who received pre-visit information about contraception (intervention group) and those who did not (control group)'}, {'measure': 'Uptake of LARC at time of uterine evacuation: Percentage of women who receive a LARC method at the time of uterine evacuation, as documented within the electronic medical record', 'timeFrame': "Day 1: Data abstraction to be performed after the subject's day 1 visit complete", 'description': 'Percentage of women who receive an implant or an IUD at the time of uterine evacuation, compared between those who received pre-visit information about contraception (intervention group) and those who did not (control group)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '30012721', 'type': 'DERIVED', 'citation': 'Roe AH, Fortin J, Gelfand D, Janiak E, Maurer R, Goldberg A. Advance notice of contraceptive availability at surgical abortion: a pilot randomised controlled trial. BMJ Sex Reprod Health. 2018 Jul;44(3):187-192. doi: 10.1136/bmjsrh-2017-200023. Epub 2018 May 18.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this project is to investigate whether a pre-visit telephone intervention could increase awareness of long-acting reversible contraception (LARC) availability at the time of uterine evacuation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Scheduled for uterine evacuation\n* Speaks English proficiently in order to understand the telephone conversation and the survey questions.\n\nExclusion Criteria:\n\n* Previous participation in this study'}, 'identificationModule': {'nctId': 'NCT02836561', 'briefTitle': 'Contraceptive Choice at the Time of Uterine Evacuation', 'organization': {'class': 'OTHER', 'fullName': 'Planned Parenthood League of Massachusetts'}, 'officialTitle': 'Contraceptive Choice at the Time of Uterine Evacuation: A Randomized Controlled Pre-visit LARC Educational Intervention', 'orgStudyIdInfo': {'id': '2016P000619'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Message', 'description': 'Participants who are randomized to the intervention message will receive contraception information in advance of their appointment that may be helpful in their decision-making.', 'interventionNames': ['Other: Telephone message']}, {'type': 'NO_INTERVENTION', 'label': 'Control Message', 'description': 'Participants who are randomized to the control message will receive appointment logistic information that may be a helpful reminder.'}], 'interventions': [{'name': 'Telephone message', 'type': 'OTHER', 'description': 'A pre-visit telephone intervention describing availability of long-acting reversible contraceptives at time of uterine evacuation', 'armGroupLabels': ['Intervention Message']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Planned Parenthood League of Massachusetts', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Principal Investigator, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Planned Parenthood League of Massachusetts'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Present at conferences and publish results in peer reviewed journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Planned Parenthood League of Massachusetts', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}