Telemedicine for First Trimester Abortion in South Africa

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Abortion in First Trimester

Clinical Trial Details

NCT number	NCT04336358
Study type	Interventional
Source	University of Cape Town
Contact	Deborah A CONSTANT, PhD
Phone	+27722527415
Email	deborah.constant@uct.ac.za
Status	Recruiting
Phase	N/A
Start date	February 27, 2020
Completion date	November 15, 2021

View Details

See also
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