Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT04336358
Status:
UNKNOWN
Last Update Posted:
2021-04-30
First Post:
2020-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telemedicine for First Trimester Abortion in South Africa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017216', 'term': 'Telemedicine'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'inferiority randomised controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2020-03-31', 'studyFirstSubmitQcDate': '2020-04-02', 'lastUpdatePostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of women who took the abortion pills as instructed', 'timeFrame': '5 days after abortion consultation', 'description': 'Proportion of women who successfully followed through with the abortion consultation and took the abortion pills as instructed'}, {'measure': 'Rate of complete abortion.', 'timeFrame': '6 weeks after abortion consultation', 'description': 'Effectiveness Rate of complete abortion. i.e. terminated pregnancy, without need of surgical or medical intervention or persistent bleeding within 6 weeks of the abortion initiation.'}], 'secondaryOutcomes': [{'measure': 'Percentage of women visiting emergency hospital visit for abortion-related symptoms', 'timeFrame': '5 days after abortion consultation', 'description': 'Emergency hospital visit for symptoms related to the abortion within two days of the intake of misoprostol'}, {'measure': 'Percentage of women hospitalised for abortion complications', 'timeFrame': '5 days after abortion consultation', 'description': 'Rate of hospitalization for complications to the abortion'}, {'measure': 'Rate of blood transfusion for heavy bleeding', 'timeFrame': '5 days after abortion consultation', 'description': 'Rate of blood transfusion for heavy bleeding during the abortion'}, {'measure': 'Percentage of women preferring telemedicine to standard care', 'timeFrame': '6 weeks after abortion consultation', 'description': 'Proportion of women selecting telemedicine vs standard care as a preferred option for a hypothetical future abortion'}, {'measure': 'Proportion of women that were satisfied or very satisfied with their abortion consultation', 'timeFrame': '6 weeks after abortion consultation', 'description': 'Proportion of women that were satisfied or very satisfied with their abortion consultation, telemedicine/standard care'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Telemedicine screening', 'Eligibility for medical abortion', 'Improved access'], 'conditions': ['Abortion in First Trimester']}, 'referencesModule': {'references': [{'pmid': '36030811', 'type': 'DERIVED', 'citation': 'Endler M, Petro G, Gemzell Danielsson K, Grossman D, Gomperts R, Weinryb M, Constant D. A telemedicine model for abortion in South Africa: a randomised, controlled, non-inferiority trial. Lancet. 2022 Aug 27;400(10353):670-679. doi: 10.1016/S0140-6736(22)01474-X.'}]}, 'descriptionModule': {'briefSummary': 'The study aim to determine if medical abortion facilitated by a physician online (s.c. telemedicine), combined with a simplified physical exam, is equally effective, safe and acceptable to women in South Africa as standard medical abortion care.', 'detailedDescription': 'The proposed study is non-inferiority randomized controlled trial that will investigate the safety, effectiveness and acceptability for women of early medical abortion performed through telemedicine, compared to standard care in South Africa. Standard care, in the Western Cape, includes face to face eligibility screening, counselling and information with a nurse or physician, as well as an ultrasound to confirm the gestational age of the pelvic exam. The intervention will include a pelvic exam and gestatonal age based on LMP assessment and uterine size by bimanual palpation. Eligibility screening, counselling and information will occur through an existing online telemedicine application, content and language-adapted to suit women in South Africa, and managed by a HPCSA certified doctor. The study is a non-inferiority study. Our hypothesis is that the intervention is not inferior to standard care with respect to safety, effectiveness and acceptability. The study is performed to provide an alternate model of abortion care to be applied in settings where abortion is in any way restricted and increase access to safe abortion. Importantly the study is planned for a context where abortion services are legal but restricted by stigma. South Africa therefore provides a uniquely suited setting for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to read and write\n* Able to speak English, IsiXhosa or Afrikaans\n* Gestational age \\<9 wks 2 days\n* In possession of a smartphone\n\nExclusion Criteria:\n\n* Contraindication to medical abortion'}, 'identificationModule': {'nctId': 'NCT04336358', 'briefTitle': 'Telemedicine for First Trimester Abortion in South Africa', 'organization': {'class': 'OTHER', 'fullName': 'University of Cape Town'}, 'officialTitle': 'Telemedicine Versus Standard Care for First Trimester Abortion in South Africa: a Randomized Controlled Noninferiority Trial', 'orgStudyIdInfo': {'id': 'UCT HREC REF 671/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Early medical abortion care', 'description': 'Counseling, history, instruction, family planning with clinic nurse. Ultrasound to assess gestational age.'}, {'type': 'EXPERIMENTAL', 'label': 'Telemedicine', 'description': 'Online consultation questionnaire and counseling, family planning information. Instruction for the abortion received to the participants Facebook Messenger. Gestational age \\<9 weeks assessed by bimanual palpation, ultrasound only in case of uncertainty.', 'interventionNames': ['Other: Telemedicine']}], 'interventions': [{'name': 'Telemedicine', 'type': 'OTHER', 'description': 'Telemedicine consultation online', 'armGroupLabels': ['Telemedicine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7530', 'city': 'Bellville', 'state': 'Western Cape', 'status': 'RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Deborah A CONSTANT, PhD', 'role': 'CONTACT', 'email': 'deborah.constant@uct.ac.za', 'phone': '+27722527415'}], 'facility': 'Karl Bremer Hospital', 'geoPoint': {'lat': -33.90022, 'lon': 18.62847}}, {'zip': '7764', 'city': 'Cape Town', 'state': 'Western Cape', 'status': 'SUSPENDED', 'country': 'South Africa', 'facility': 'Vanguard CHC', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7784', 'city': 'Khayelitsha', 'state': 'Western Cape', 'status': 'SUSPENDED', 'country': 'South Africa', 'facility': 'Michael Mapongwana CHC', 'geoPoint': {'lat': -34.03932, 'lon': 18.67916}}, {'zip': '7785', 'city': 'Mitchells Plain', 'state': 'Western Cape', 'status': 'SUSPENDED', 'country': 'South Africa', 'facility': 'Mitchells Plain CHC', 'geoPoint': {'lat': -34.05341, 'lon': 18.62365}}], 'centralContacts': [{'name': 'Deborah A CONSTANT, PhD', 'role': 'CONTACT', 'email': 'deborah.constant@uct.ac.za', 'phone': '+27722527415'}, {'name': 'Margit Endler, PhD', 'role': 'CONTACT', 'email': 'margit.endler@gmail.com', 'phone': '+27646176477'}], 'overallOfficials': [{'name': 'Deborah A CONSTANT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cape Town'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'After main findings have been published, for 3 years.', 'ipdSharing': 'YES', 'description': "Data base will be shared upon reasonable request accompanied by requester's protocol", 'accessCriteria': "Email request to Principal Investigators. Accompanied by requester's protocol and Ethics approval"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cape Town', 'class': 'OTHER'}, 'collaborators': [{'name': 'Grand Challenges Canada', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Director, Head of Women's Health Research Unit, Principal Investigator, Senior Researcher", 'investigatorFullName': 'Deborah Constant, Dr', 'investigatorAffiliation': 'University of Cape Town'}}}}