Telemedicine Versus Standard Care for First Trimester Abortion in South Africa: a Randomized Controlled Noninferiority Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Abortion in First Trimester
- Sponsor
- University of Cape Town
- Enrollment
- 900
- Locations
- 4
- Primary Endpoint
- Proportion of women who took the abortion pills as instructed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Deborah Constant, Dr
Director, Head of Women's Health Research Unit, Principal Investigator, Senior Researcher
University of Cape Town
Eligibility Criteria
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
Outcomes
Primary Outcomes
Proportion of women who took the abortion pills as instructed
Time Frame: 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.
Time Frame: 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 Outcomes
- Proportion of women that were satisfied or very satisfied with their abortion consultation(6 weeks after abortion consultation)
- Percentage of women visiting emergency hospital visit for abortion-related symptoms(5 days after abortion consultation)
- Percentage of women hospitalised for abortion complications(5 days after abortion consultation)
- Rate of blood transfusion for heavy bleeding(5 days after abortion consultation)
- Percentage of women preferring telemedicine to standard care(6 weeks after abortion consultation)