Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202004661941593 Date of Approval: 02/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Telemedicine versus standard care for first trimester abortion in South Africa: a randomized controlled non-inferiority trial
Official scientific title Telemedicine versus standard care for first trimester abortion in South Africa: a randomized controlled non-inferiority trial
Brief summary describing the background and objectives of the trial 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. The study will be performed in a controlled setting, with good access to emergency care services, constant access to study staff and follow-up of study participants at 3 and 40 days after the 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. Illegal abortion is common in South Africa. Legal restrictions on abortion are not the only barrier to access, legalizing abortion and requiring health centres to provide abortion has not stopped South African women from turning to clandestine providers. The use of existing safe and legal abortion services is hindered by high abortion-related stigma and a lack of skilled and willing provider. Complications to unsafe abortion contribute to preventable maternal deaths i
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Telemedicine
Anticipated trial start date 06/01/2020
Actual trial start date 27/02/2020
Anticipated date of last follow up 16/05/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 900
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard early medical abortion care day of visit Counseling, history, instruction, family planning with clinic nurse. Ultrasound to assess gestational age. 450 Active-Treatment of Control Group
Experimental Group Telemedicine for early medical abortion day of visit 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. 450
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
>18 years old Able to read and write Able to speak English, IsiXhosa or Afrikaans Gestational age <9 wks 2 days In possesion of a smartphone Contraindication to medical abortion Adult: 19 Year-44 Year 18 Year(s) 60 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/12/2019 Human Research Ethics Committee HREC University of Cape Town
Ethics Committee Address
Street address City Postal code Country
Groote Schuur Hospital, Main Rd, Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Feasibility. Proportion of women who successfully followed through with the abortion consultation and took the abortion pills as instructed 5 days after abortion consultation
Primary Outcome 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 Safety- Emergency hospital visit for symptoms related to the abortion within two days of the intake of Misoprostol 5 days after abortion consultation
Secondary Outcome Safety - rate of hospitalization for complications to the abortion 5 days after the abortion consultation
Secondary Outcome Safety rate of blood transfusion for heavy bleeding during the abortion 5 days after the abortion consultation
Secondary Outcome Acceptability- proportion of women selecting telemedicine vs standard care as a preferred option for a hypothetical future abortion 6 weeks after the abortion consultation
Secondary Outcome Acceptability- Proportion of women that were satisfied or very satisfied with their abortion consultation, telemedicine/standard care 6 weeks after the abortion consultation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Michael Mapongwana CHC Steve Biko Road, Harare Cape Town 7784 South Africa
Mitchells Plain CHC First Ave, Beacon Valley Cape Town 7785 South Africa
Vanguard CHC Candlewood Street, Bonteheuwel Cape Town 7764 South Africa
Nolungile Youth Clinic Sololmon Tshuku Ave, Khayelitsha Cape Town 7784 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenges Canada OPTIONS initiative 661, University Avenue, ON M5G 1M1 Toronto Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Cape Town Anzio Road, Observatory Cape Town 7925 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dan Grossman Advancing New Standards in Reproductive Health ANSIRH 330 Broadway Oakland Californa 1100 United States of America
Kristina Gemzell Danielsson Karolinska Institutet Tomtebodavagen 18 Stockholm 17177 Sweden
Rebecca Gomperts Women on Web PO BOX 15683 Amsterdam 1001 Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Margit Endler margit.endler@ki.se +27646176477 Anzio Road
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Postdoctoral researcher
Role Name Email Phone Street address
Principal Investigator Deborah Constant deborah.constant@uct.ac.za +27722527415 Anzio Road
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Head of research unit
Role Name Email Phone Street address
Public Enquiries Margit Endler margit.endler@ki.se +27646176477 anzio rd, observatory
City Postal code Country Position/Affiliation
cape town South Africa Postdoctoral researcher
Role Name Email Phone Street address
Scientific Enquiries Margit Endler margit.endler@ki.se +27646176477 Anzio Road
City Postal code Country Position/Affiliation
Cape Town South Africa postdoctoral researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The study raw data (anonymized) will be shared with researchers and reviewers fulfilling criteria upon request. Summary results will be shared with the registration record within 12 months of the study completion date. Analytic Code,Clinical Study Report,Informed Consent Form,Study Protocol The IPD and additional documenst will be made available within 12 months of the study completion date. Raw data (anonymized) and additional documents will be made available to researchers or reviewers through contact with the two principal investigators. Permission will be granted to researchers from academic institutions or academic journals if the purpose of the data request is clearly stated as research-related, the request is legitimate, and the data is used and analyzed with full transparency. Permission/denial to access data will be granted by a third party (university of cape town human research ethics board) in case of doubt or disagreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information