Telemedicine for First Trimester Abortion in South Africa

Abortion in First Trimester Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04336358
• Other study ID #: UCT HREC REF 671/2019
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2020
• Est. completion date: November 15, 2021

Study information

• Verified date: April 2021
• Source: University of Cape Town
• Contact: Deborah A CONSTANT, PhD
• Phone: +27722527415
• Email: deborah.constant[@]uct.ac.za
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: November 15, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion in First Trimester

Intervention

Other:
• Telemedicine
Telemedicine consultation online

Locations

Country	Name	City	State
South Africa	Karl Bremer Hospital	Bellville	Western Cape
South Africa	Vanguard CHC	Cape Town	Western Cape
South Africa	Michael Mapongwana CHC	Khayelitsha	Western Cape
South Africa	Mitchells Plain CHC	Mitchells Plain	Western Cape

Sponsors (4)

Lead Sponsor	Collaborator
University of Cape Town	Grand Challenges Canada, Karolinska Institutet, University of California, San Francisco

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Percentage of women hospitalised for abortion complications	Rate of hospitalization for complications to the abortion	5 days after abortion consultation
Secondary	Rate of blood transfusion for heavy bleeding	Rate of blood transfusion for heavy bleeding during the abortion	5 days after abortion consultation
Secondary	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
Secondary	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