Telemedicine for First Trimester Abortion in South Africa

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

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.

Study Overview

• Status: Recruiting
• Conditions: Abortion in First Trimester
• Intervention / Treatment: Other: Telemedicine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deborah A CONSTANT, PhD; Phone Number: +27722527415; Email: deborah.constant@uct.ac.za
• Study Contact Backup: Name: Margit Endler, PhD; Phone Number: +27646176477; Email: margit.endler@gmail.com

Study Locations

• South Africa
  • Western Cape
    • Bellville, Western Cape, South Africa, 7530
      • Recruiting
      • Karl Bremer Hospital
      • Contact: Deborah A CONSTANT, PhD; Phone Number: +27722527415; Email: deborah.constant@uct.ac.za
    • Cape Town, Western Cape, South Africa, 7764
      • Suspended
      • Vanguard CHC
    • Khayelitsha, Western Cape, South Africa, 7784
      • Suspended
      • Michael Mapongwana CHC
    • Mitchells Plain, Western Cape, South Africa, 7785
      • Suspended
      • Mitchells Plain CHC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Standard Early medical abortion care; Counseling, history, instruction, family planning with clinic nurse. Ultrasound to assess gestational age.
EXPERIMENTAL: Telemedicine; Online consultation questionnaire and counseling, family planning information. Instruction for the abortion received to the participants Facebook Messenger. Gestational age <9 weeks assessed by bimanual palpation, ultrasound only in case of uncertainty.	Other: Telemedicine; Telemedicine consultation online

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Percentage of women hospitalised for abortion complications	Rate of hospitalization for complications to the abortion	5 days after abortion consultation
Rate of blood transfusion for heavy bleeding	Rate of blood transfusion for heavy bleeding during the abortion	5 days after abortion consultation
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
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

Collaborators and Investigators

• Sponsor: University of Cape Town
• Collaborators: Karolinska Institutet; University of California, San Francisco; Grand Challenges Canada
• Investigators: Principal Investigator: Deborah A CONSTANT, PhD, University of Cape Town

Publications and helpful links

General Publications

• 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. Erratum In: Lancet. 2022 Oct 8;400(10359):1194.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 27, 2020
• Primary Completion (ANTICIPATED): September 30, 2021
• Study Completion (ANTICIPATED): November 15, 2021

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (ACTUAL): April 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Telemedicine screening; Eligibility for medical abortion; Improved access
• Other Study ID Numbers: UCT HREC REF 671/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data base will be shared upon reasonable request accompanied by requester's protocol
• IPD Sharing Time Frame: After main findings have been published, for 3 years.
• IPD Sharing Access Criteria: Email request to Principal Investigators. Accompanied by requester's protocol and Ethics approval
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No