NCT04336358

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

1.6 years

First QC Date

March 31, 2020

Last Update Submit

April 27, 2021

Conditions

Abortion in First Trimester

Keywords

Telemedicine screeningEligibility for medical abortionImproved access

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Percentage of women visiting emergency hospital visit for abortion-related symptoms

    5 days after abortion consultation

  • Percentage of women hospitalised for abortion complications

    5 days after abortion consultation

  • Rate of blood transfusion for heavy bleeding

    5 days after abortion consultation

  • Percentage of women preferring telemedicine to standard care

    6 weeks after abortion consultation

  • Proportion of women that were satisfied or very satisfied with their abortion consultation

    6 weeks after abortion consultation

Study Arms (2)

Standard Early medical abortion care

NO INTERVENTION

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

Telemedicine

EXPERIMENTAL

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

Interventions

TelemedicineOTHER

Telemedicine consultation online

Telemedicine

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Able to read and write
  • Able to speak English, IsiXhosa or Afrikaans
  • Gestational age \<9 wks 2 days
  • In possession of a smartphone

You may not qualify if:

  • Contraindication to medical abortion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Karl Bremer Hospital

Bellville, Western Cape, 7530, South Africa

RECRUITING

Vanguard CHC

Cape Town, Western Cape, 7764, South Africa

SUSPENDED

Michael Mapongwana CHC

Khayelitsha, Western Cape, 7784, South Africa

SUSPENDED

Mitchells Plain CHC

Mitchells Plain, Western Cape, 7785, South Africa

SUSPENDED

Related Publications (1)

  • 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.

    PMID: 36030811DERIVED

MeSH Terms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Deborah A CONSTANT, PhD

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah A CONSTANT, PhD

CONTACT

+27722527415deborah.constant@uct.ac.za

Margit Endler, PhD

CONTACT

+27646176477margit.endler@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: inferiority randomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Women's Health Research Unit, Principal Investigator, Senior Researcher

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 7, 2020

Study Start

February 27, 2020

Primary Completion

September 30, 2021

Study Completion

November 15, 2021

Last Updated

April 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

Data base will be shared upon reasonable request accompanied by requester's protocol

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
After main findings have been published, for 3 years.
Access Criteria
Email request to Principal Investigators. Accompanied by requester's protocol and Ethics approval

Locations

ZA(4)