Trial no.:
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PACTR202004661941593 |
Date of Approval:
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02/04/2020 |
Trial Status:
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Registered in accordance with WHO and ICMJE standards |
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TRIAL DESCRIPTION |
Public title
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Telemedicine versus standard care for first trimester abortion in South Africa: a randomized controlled non-inferiority trial |
Official scientific title |
Telemedicine versus standard care for first trimester abortion in South Africa: a randomized controlled non-inferiority trial |
Brief summary describing the background
and objectives of the trial
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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.
The study will be performed in a controlled setting, with good access to emergency care services, constant access to study staff and follow-up of study participants at 3 and 40 days after the 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.
Illegal abortion is common in South Africa. Legal restrictions on abortion are not the only barrier to access, legalizing abortion and requiring health centres to provide abortion has not stopped South African women from turning to clandestine providers. The use of existing safe and legal abortion services is hindered by high abortion-related stigma and a lack of skilled and willing provider. Complications to unsafe abortion contribute to preventable maternal deaths i |
Type of trial |
RCT |
Acronym (If the trial has an acronym then please provide) |
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Disease(s) or condition(s) being studied |
Obstetrics and Gynecology |
Sub-Disease(s) or condition(s) being studied |
Fertility-female |
Purpose of the trial |
Telemedicine |
Anticipated trial start date |
06/01/2020 |
Actual trial start date |
27/02/2020 |
Anticipated date of last follow up |
16/05/2021 |
Actual Last follow-up date |
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Anticipated target sample size (number of participants) |
900 |
Actual target sample size (number of participants) |
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Recruitment status |
Recruiting |
Publication URL |
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