Telemedicine for First Trimester Abortion in South Africa

Last updated: April 27, 2021
Sponsor: University of Cape Town
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04336358
UCT HREC REF 671/2019
  • Ages 18-44
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Contraindication to medical abortion

Study Design

Total Participants: 900
Study Start date:
February 27, 2020
Estimated Completion Date:
November 15, 2021

Study 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.

Connect with a study center

  • Karl Bremer Hospital

    Bellville, Western Cape 7530
    South Africa

    Active - Recruiting

  • Vanguard CHC

    Cape Town, Western Cape 7764
    South Africa

    Suspended

  • Michael Mapongwana CHC

    Khayelitsha, Western Cape 7784
    South Africa

    Suspended

  • Mitchells Plain CHC

    Mitchells Plain, Western Cape 7785
    South Africa

    Suspended

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