Telemedicine for First Trimester Abortion in South Africa
NCT ID: NCT04336358
Last Updated: 2021-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
900 participants
INTERVENTIONAL
2020-02-27
2021-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Standard Early medical abortion care
Counseling, history, instruction, family planning with clinic nurse. Ultrasound to assess gestational age.
No interventions assigned to this group
Telemedicine
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.
Telemedicine
Telemedicine consultation online
Interventions
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Telemedicine
Telemedicine consultation online
Eligibility Criteria
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Inclusion Criteria
* Able to speak English, IsiXhosa or Afrikaans
* Gestational age \<9 wks 2 days
* In possession of a smartphone
Exclusion Criteria
18 Years
44 Years
FEMALE
Yes
Sponsors
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Grand Challenges Canada
OTHER
University of California, San Francisco
OTHER
Karolinska Institutet
OTHER
University of Cape Town
OTHER
Responsible Party
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Deborah Constant, Dr
Director, Head of Women's Health Research Unit, Principal Investigator, Senior Researcher
Principal Investigators
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Deborah A CONSTANT, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cape Town
Locations
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Karl Bremer Hospital
Bellville, Western Cape, South Africa
Vanguard CHC
Cape Town, Western Cape, South Africa
Michael Mapongwana CHC
Khayelitsha, Western Cape, South Africa
Mitchells Plain CHC
Mitchells Plain, Western Cape, South Africa
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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UCT HREC REF 671/2019
Identifier Type: -
Identifier Source: org_study_id
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