Clinical Trials Logo

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


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

See also
  Status Clinical Trial Phase
Terminated NCT04056637 - Choice of Modality of Follow up for Medication Abortion N/A
Active, not recruiting NCT05896657 - Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713 N/A
Active, not recruiting NCT03736681 - Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage Phase 1
Completed NCT03636451 - Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o Phase 3
Completed NCT04446572 - Application of Lactobacillus Salivarius CECT5713 in Infertility of Unknown Origin Phase 2
Not yet recruiting NCT03267771 - Progesterone and Doppler in Recurrent Abortion Phase 4
Recruiting NCT05341817 - The Use of Letrozole or Mifepristone for Pretreatment of Medical Termination of Pregnancy Phase 4
Completed NCT03079622 - Manual Versus Electric Vacuum Aspiration for Pregnancy Termination Between 10-14 Weeks N/A
Recruiting NCT05182008 - A Patient Decision Aid for Method of Early Abortion: A Randomized Control Trial N/A
Completed NCT03417362 - Delivery of Audiovisual Information on Early Medical Abortion N/A
Completed NCT03896022 - Auriculotherapy - Pain Management of Aspiration Abortion N/A
Completed NCT03925129 - Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management With Medication Abortion Through 70 Days' Gestation N/A
Suspended NCT03751423 - Intravenous Ketamine for Pain Control During First Trimester Surgical Abortion Phase 3
Completed NCT03480009 - Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion Phase 3
Completed NCT05469594 - Second-trimester TOP : a Retrospective Study Comparing Complications at 12-14 vs 14-16 Weeks of Gestation
Enrolling by invitation NCT05320432 - Transcutaneous Electrical Nerve Stimulation for Pain Control During First-trimester Abortion N/A
Completed NCT03187002 - Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion N/A
Terminated NCT04139382 - Using Telemedicine to Improve Early Medical Abortion at Home N/A
Recruiting NCT04956731 - Pharmacist Provision of Medication Abortion N/A
Completed NCT02096575 - Nitrous Oxide for Pain Management of First Trimester Surgical Abortion N/A