Clinical trial NCT04336358: Telemedicine for First Trimester Abortion in South Africa
Official title: Telemedicine Versus Standard Care for First Trimester Abortion in South Africa: a Randomized Controlled Noninferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abortion in First Trimester
Keywords: Telemedicine screening
Eligibility for medical abortion
Improved access
Lead sponsor: University of Cape Town
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: University of California, San Francisco
name: Karolinska Institutet
First posted: 2020-04-07
Enrollment: 900
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: inferiority randomised controlled trial
Primary purpose: SCREENING

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of women who took the abortion pills as instructed
timeFrame: 5 days after abortion consultation
measure: Rate of complete abortion.
timeFrame: 6 weeks after abortion consultation
Secondary outcomes:
measure: Percentage of women visiting emergency hospital visit for abortion-related symptoms
timeFrame: 5 days after abortion consultation
measure: Percentage of women hospitalised for abortion complications
timeFrame: 5 days after abortion consultation
measure: Rate of blood transfusion for heavy bleeding
timeFrame: 5 days after abortion consultation
measure: Percentage of women preferring telemedicine to standard care
timeFrame: 6 weeks after abortion consultation
measure: Proportion of women that were satisfied or very satisfied with their abortion consultation
timeFrame: 6 weeks after abortion consultation
Other outcomes:
Locations:
city: Bellville
country: South Africa
facility: Karl Bremer Hospital
state: Western Cape
city: Cape Town
country: South Africa
facility: Vanguard CHC
state: Western Cape
city: Khayelitsha
country: South Africa
facility: Michael Mapongwana CHC
state: Western Cape
city: Mitchells Plain
country: South Africa
facility: Mitchells Plain CHC
state: Western Cape
Study officials:
affiliation: University of Cape Town
name: Deborah A CONSTANT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Endler M, Petro G, Gemzell Danielsson K, Grossman D, Gomperts R, Weinryb M, Constant D. A telemedicine model for abortion in South Africa: a randomised, controlled, non-inferiority trial. Lancet. 2022 Aug 27;400(10353):670-679. doi: 10.1016/S0140-6736(22)01474-X.