Telemedicine for First Trimester Abortion in South Africa

University of Cape Town (UCT)

Status: Unknown

Conditions: Abortion in First Trimester

Treatments: Other: Telemedicine

Study type: Interventional

Funder types: Other

Identifiers

NCT04336358

UCT HREC REF 671/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 2 patient groups

Standard Early medical abortion care

No Intervention group

Description:

Counseling, history, instruction, family planning with clinic nurse. Ultrasound to assess gestational age.

Telemedicine

Experimental group

Description:

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.

Treatment:

Other: Telemedicine