Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT06042556
Status:
COMPLETED
Last Update Posted:
2023-09-18
First Post:
2023-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IUD Self-Removal: Evaluating an Online Guide for Self-removal in Clinical and Non-clinical Settings
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': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-14', 'studyFirstSubmitDate': '2023-09-08', 'studyFirstSubmitQcDate': '2023-09-14', 'lastUpdatePostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of successful IUD self-removal rates', 'timeFrame': 'The post study survey will be completed within 48 hours of study participation. Participants schedule their participation on average 1-3 months from study enrollment but up to 1 year (the duration of the study being open).', 'description': 'Successful self-removal will be reported by participants on the post-study survey and documented with an uploaded photo of the removed IUD on a study ruler sheet. Rates of successful self-removal will be compared between those randomized to the guide versus no additional resource.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IUD', 'Contraception']}, 'descriptionModule': {'briefSummary': 'Investigators previously developed a guide to help people with IUD self-removal. In this randomized study, the goal is to see if this guide makes it easier for IUD-users to remove their own IUDs.\n\nThe main question the study aims to answer is:\n\n-Does use of the previously developed IUD self-removal guide increase rates of self removal?\n\nParticipants will:\n\n* Complete a pre-study survey\n* Be randomized to self-removal with use of the guide or no additional resource\n* Self-select participation at home or in clinic\n* Attempt IUD self-removal either at home or in clinic\n* Complete a post-study survey.\n\nInvestigators will compare rates of successful self-removal between those randomized to the guide to those randomized to no additional resource to see if increases success.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 14 and older\n* IUD in place and desiring removal\n* Interest in attempting self-removal\n* English speaking\n* Working cell-phone with camera.\n\nExclusion Criteria:\n\n* Not meeting above inclusion criteria, no other specific exclusion criteria'}, 'identificationModule': {'nctId': 'NCT06042556', 'briefTitle': 'IUD Self-Removal: Evaluating an Online Guide for Self-removal in Clinical and Non-clinical Settings', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'A Randomized Trial Evaluating the Effectiveness of a Previously Developed Online IUD Self-removal Guide Versus Basic Information Sheet in Clinical and Non-clinical Settings', 'orgStudyIdInfo': {'id': 'STUDY00014317'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Guide', 'description': 'Randomized to use of our IUD self-removal guide', 'interventionNames': ['Other: IUD self-removal guide']}, {'type': 'NO_INTERVENTION', 'label': 'No guide', 'description': 'Randomized to use of no additional resource'}], 'interventions': [{'name': 'IUD self-removal guide', 'type': 'OTHER', 'description': 'We previously developed an online guide for IUD self-removal through an iterative process including advice from key expert informants, focus groups, interviews, and a pilot clinical study. It includes an online animation, step-by-step guide, troubleshooting tips, and information about pregnancy and contraception.', 'armGroupLabels': ['Guide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Cedar River Clinics', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}], 'overallOfficials': [{'name': 'Kelsey Petrie, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Instructor', 'investigatorFullName': 'Kelsey Petrie', 'investigatorAffiliation': 'University of Washington'}}}}