Telemedicine for First Trimester Abortion in South Africa

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Telemedicine Versus Standard Care for First Trimester Abortion in South Africa: a Randomized Controlled Noninferiority Trial

Conditions
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Abortion in First Trimester

Intervention / Treatment
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* Other: Telemedicine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: inferiority randomised controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Early medical abortion care<br>Counseling, history, instruction, family planning with clinic nurse. Ultrasound to assess gestational age. | |
| Experimental: Telemedicine<br>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. | Other: Telemedicine<br>* Telemedicine consultation online<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine screening, Eligibility for medical abortion, Improved access