Telemedicine for First Trimester Abortion in South Africa

Not Applicable

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Telemedicine	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
Percentage of women hospitalised for abortion complications	5 days after abortion consultation	Rate of hospitalization for complications to the abortion
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 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

Locations (4): Vanguard CHC
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Cape Town, Western Cape, South Africa
Michael Mapongwana CHC
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Khayelitsha, Western Cape, South Africa
Mitchells Plain CHC
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Mitchells Plain, Western Cape, South Africa
Karl Bremer Hospital
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Bellville, Western Cape, South Africa