Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-01 @ 2:23 PM
Study NCT ID:
NCT02672605
Status:
COMPLETED
Last Update Posted:
2016-08-01
First Post:
2016-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Individual Level of Abortion Stigma Study
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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-29', 'studyFirstSubmitDate': '2016-01-26', 'studyFirstSubmitQcDate': '2016-01-29', 'lastUpdatePostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Individual level stigma scores', 'timeFrame': 'Stigma store is collected during one 30-minute study visit, either directly prior or directly following the patient being consented using the PA Abortion Control Act language'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Abortion Stigma']}, 'descriptionModule': {'briefSummary': 'This study is a randomized controlled trial designed to measure abortion stigma related to the Pennsylvania Abortion Control Act. Women seeking abortion will be randomized to receive the validated Individual Level Abortion Stigma Scale either before or after consent via the Pennsylvania Abortion Control Act language. The primary outcome will be the stigma scores in the two groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women ≥18 years old\n2. Seeking induced abortion for any indication\n3. Gestation ≤ 24 weeks\n4. Plan for procedural or state consent at current visit\n5. Willing and able to consent in English\n\nExclusion Criteria:\n\n1. Have previously been consented in the current pregnancy using the Pennsylvania Abortion Control Act consent language\n2. Have previously had an abortion'}, 'identificationModule': {'nctId': 'NCT02672605', 'briefTitle': 'Measurement of Individual Level of Abortion Stigma Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Measurement of Individual-Level Abortion Stigma Resulting From Pennsylvania State-Mandated Abortion Consent Language: A Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '823273'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participant completes a survey measuring abortion stigma prior to receiving the mandatory Pennsylvania State consent for their abortion.'}, {'type': 'EXPERIMENTAL', 'label': 'Investigational', 'description': 'Participant completes a survey measuring abortion stigma after receiving the mandatory Pennsylvania State consent for their abortion.', 'interventionNames': ['Other: Pennsylvania State Abortion Consent']}], 'interventions': [{'name': 'Pennsylvania State Abortion Consent', 'type': 'OTHER', 'description': 'Measuring the level of stigma felt pre- or post-exposure to the abortion consent language.', 'armGroupLabels': ['Investigational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn Family Planning and Pregnancy Loss Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Sarita Sonalkar, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}