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| Name | Class |
|---|---|
| Grand Challenges Canada | OTHER |
| University of California, San Francisco | OTHER |
| Karolinska Institutet | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Early medical abortion care | No Intervention | Counseling, history, instruction, family planning with clinic nurse. Ultrasound to assess gestational age. | |
| Telemedicine | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine | Other | Telemedicine consultation online |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of women who took the abortion pills as instructed | Proportion of women who successfully followed through with the abortion consultation and took the abortion pills as instructed | 5 days after abortion consultation |
| Rate of complete abortion. | 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. | 6 weeks after abortion consultation |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of women visiting emergency hospital visit for abortion-related symptoms | Emergency hospital visit for symptoms related to the abortion within two days of the intake of misoprostol | 5 days after abortion consultation |
| Percentage of women hospitalised for abortion complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deborah A CONSTANT, PhD | Contact | +27722527415 | deborah.constant@uct.ac.za | |
| Margit Endler, PhD | Contact | +27646176477 | margit.endler@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Deborah A CONSTANT, PhD | University of Cape Town | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karl Bremer Hospital | Recruiting | Bellville | Western Cape | 7530 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36030811 | Derived | 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. |
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Data base will be shared upon reasonable request accompanied by requester's protocol
After main findings have been published, for 3 years.
Email request to Principal Investigators. Accompanied by requester's protocol and Ethics approval
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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inferiority randomised controlled trial
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Rate of hospitalization for complications to the abortion |
| 5 days after abortion consultation |
| Rate of blood transfusion for heavy bleeding | Rate of blood transfusion for heavy bleeding during the abortion | 5 days after abortion consultation |
| Percentage of women preferring telemedicine to standard care | Proportion of women selecting telemedicine vs standard care as a preferred option for a hypothetical future abortion | 6 weeks after abortion consultation |
| Proportion of women that were satisfied or very satisfied with their abortion consultation | Proportion of women that were satisfied or very satisfied with their abortion consultation, telemedicine/standard care | 6 weeks after abortion consultation |
| Vanguard CHC | Suspended | Cape Town | Western Cape | 7764 | South Africa |
| Michael Mapongwana CHC | Suspended | Khayelitsha | Western Cape | 7784 | South Africa |
| Mitchells Plain CHC | Suspended | Mitchells Plain | Western Cape | 7785 | South Africa |