Abortion in First Trimester
Conditions
Keywords
Telemedicine screening, Eligibility for medical abortion, Improved access
Brief summary
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.
Detailed description
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.
Interventions
OTHERTelemedicine
Telemedicine consultation online
Sponsors
Grand Challenges Canada
University of California, San Francisco
Karolinska Institutet
University of Cape Town
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
inferiority randomised controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* Able to read and write * Able to speak English, IsiXhosa or Afrikaans * Gestational age \<9 wks 2 days * In possession of a smartphone
Exclusion criteria
* Contraindication to medical abortion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of women who took the abortion pills as instructed | 5 days after abortion consultation | Proportion of women who successfully followed through with the abortion consultation and took the abortion pills as instructed |
| Rate of complete abortion. | 6 weeks after abortion consultation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of blood transfusion for heavy bleeding | 5 days after abortion consultation | Rate of blood transfusion for heavy bleeding during the abortion |
| Percentage of women visiting emergency hospital visit for abortion-related symptoms | 5 days after abortion consultation | Emergency hospital visit for symptoms related to the abortion within two days of the intake of misoprostol |
| Proportion of women that were satisfied or very satisfied with their abortion consultation | 6 weeks after abortion consultation | Proportion of women that were satisfied or very satisfied with their abortion consultation, telemedicine/standard care |
| Percentage of women preferring telemedicine to standard care | 6 weeks after abortion consultation | Proportion of women selecting telemedicine vs standard care as a preferred option for a hypothetical future abortion |
| Percentage of women hospitalised for abortion complications | 5 days after abortion consultation | Rate of hospitalization for complications to the abortion |
Countries
South Africa
Contacts
Primary ContactDeborah A CONSTANT, PhD
Backup ContactMargit Endler, PhD
Outcome results
None listed