Telemedicine for First Trimester Abortion in South Africa

NCT ID: NCT04336358

Last Updated: 2021-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-27

Study Completion Date

2021-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Abortion in First Trimester

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

inferiority randomised controlled trial
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard Early medical abortion care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Telemedicine

Intervention Type OTHER

Telemedicine consultation online

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Telemedicine

Telemedicine consultation online

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Grand Challenges Canada

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

University of Cape Town

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Deborah Constant, Dr

Director, Head of Women's Health Research Unit, Principal Investigator, Senior Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Deborah A CONSTANT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cape Town

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Karl Bremer Hospital

Bellville, Western Cape, South Africa

Site Status RECRUITING

Vanguard CHC

Cape Town, Western Cape, South Africa

Site Status SUSPENDED

Michael Mapongwana CHC

Khayelitsha, Western Cape, South Africa

Site Status SUSPENDED

Mitchells Plain CHC

Mitchells Plain, Western Cape, South Africa

Site Status SUSPENDED

Countries

Review the countries where the study has at least one active or historical site.

South Africa

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Deborah A CONSTANT, PhD

Role: CONTACT

+27722527415

Margit Endler, PhD

Role: CONTACT

+27646176477

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Deborah A CONSTANT, PhD

Role: primary

+27722527415

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 36030811 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UCT HREC REF 671/2019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Misoprostol in Missed Abortion
NCT06818903 NOT_YET_RECRUITING