Abortion in First TrimesterNCT04336358
Telemedicine for First Trimester Abortion in South Africa
A study testing Telemedicine in people with Abortion in First Trimester, run by University of Cape Town at 4 sites in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion in First Trimester
- What is being tested?
- Telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 4 sitesSouth Africa
- Study dates
- 27 Feb 2020to 15 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to read and write
- Able to speak English, IsiXhosa or Afrikaans
- Gestational age <9 wks 2 days
- In possession of a smartphone
Who cannot join
- Contraindication to medical abortion
Trial locations and contacts
4 sites in 1 country.
South Africa4 sites, 1 recruiting
- Recruiting
Karl Bremer Hospital
Bellville, Western Cape, 7530
Deborah A CONSTANT, PhD, +27722527415, deborah.constant@uct.ac.za
- Suspended
Vanguard CHC
Cape Town, Western Cape, 7764
- Suspended
Michael Mapongwana CHC
Khayelitsha, Western Cape, 7784
- Suspended
Mitchells Plain CHC
Mitchells Plain, Western Cape, 7785
About this study
Official title: 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.
Read the 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.
- Conditions
- Abortion in First Trimester
- Being tested
- Telemedicine
- Keywords
- Telemedicine screening, Eligibility for medical abortion, Improved access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Telemedicine consultation online
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 6 weeks after abortion consultation
Secondary outcomes (5)
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
Measured: 5 days after abortion consultation
Percentage of women hospitalised for abortion complications
Rate of hospitalization for complications to the abortion
Measured: 5 days after abortion consultation
Rate of blood transfusion for heavy bleeding
Rate of blood transfusion for heavy bleeding during the abortion
Measured: 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
Measured: 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
Measured: 6 weeks after abortion consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start27 Feb 2020
- Primary completion30 Sep 2021 (estimated)
- Study completion15 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abortion in First TrimesterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- inferiority randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada, University of California, San Francisco, Karolinska Institutet
- Responsible party
- Principal investigator, Deborah Constant, Dr, University of Cape Town
- Investigators
- Deborah A CONSTANT, PhD, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336358
- Sponsor's protocol ID
- UCT HREC REF 671/2019
- Status last verified
- Apr 2021
- First submitted
- 31 Mar 2020
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data base will be shared upon reasonable request accompanied by requester's protocol
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.
PubMed 36030811
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine Versus Standard Care for First Trimester Abortion in South Africa: a Randomized Controlled Noninferiority Trial
- ClinicalTrials.gov ID
- NCT04336358
- Acronym / sponsor ID
- UCT HREC REF 671/2019
- Conditions
- Abortion in First Trimester
- Keywords
- Telemedicine screening, Eligibility for medical abortion, Improved access
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Grand Challenges Canada, University of California, San Francisco, Karolinska Institutet
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 15 Nov 2021 (estimated)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- inferiority randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard Early medical abortion care | No intervention | –Counseling, history, instruction, family planning with clinic nurse. Ultrasound to assess gestational age. |
| Telemedicine | Experimental | Other: TelemedicineOnline 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Able to read and write
- Able to speak English, IsiXhosa or Afrikaans
- Gestational age <9 wks 2 days
- In possession of a smartphone
Key exclusion criteria (1 listed)
- Contraindication to medical abortion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicineTelemedicine consultation online | Other | Telemedicine |
Primary outcome
Proportion of women who took the abortion pills as instructed
Time frame: 5 days after abortion consultation
Proportion of women who successfully followed through with the abortion consultation and took the abortion pills as instructed
Rate of complete abortion.
Time frame: 6 weeks after abortion consultation
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.
5 secondary outcomes
Percentage of women visiting emergency hospital visit for abortion-related symptoms
Time frame: 5 days after abortion consultation
Percentage of women hospitalised for abortion complications
Time frame: 5 days after abortion consultation
Rate of blood transfusion for heavy bleeding
Time frame: 5 days after abortion consultation
Percentage of women preferring telemedicine to standard care
Time frame: 6 weeks after abortion consultation
Proportion of women that were satisfied or very satisfied with their abortion consultation
Time frame: 6 weeks after abortion consultation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Derived from this study: PubMed 36030811Endler 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.
- Individual participant dataSharing planned: Yes. Data base will be shared upon reasonable request accompanied by requester's protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah A CONSTANT, PhD principal investigator
University of Cape Town
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Abortion in First Trimester, run by University of Cape Town at 4 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deborah A CONSTANT, PhD (+27722527415, deborah.constant@uct.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women who took the abortion pills as instructed (time frame: 5 days after abortion consultation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04336358, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.