Medical Abortion CounsellingNCT03461653
Telemedicin Counselling for Medical Abortion
A study testing Telemedicine counselling in people with Medical Abortion Counselling, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The guidance on Safe abortion technology by the World Health Organization (WHO 2012) suggests the evaluation of internet provision and telemedicine, as further alternative service delivery channels of safe abortion, as a subject for future research (WHO 2012) Our studies have shown that telemedicine and provision of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Medical Abortion Counselling
- What is being tested?
- Telemedicine counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,598 participants
- Where
- 1 siteSweden
- Study dates
- 4 Apr 2018to 30 Sep 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- requesting termination of pregnancy by means of mifepristone followed by home administration of misoprostol at < /=63 days of gestation, no contraindication to medical abortion and self administration of misoprostol at home, and who have given their informed consent
Who cannot join
- women who do not want home administration of misoprostol, women who are unable to communicate in Swedish, or English, and women with symptoms and signs of ectopic pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Medical Abortion Through Telemedicine Versus Standard Provision - a Randomised Controlled Non-inferiority Trial
The guidance on Safe abortion technology by the World Health Organization (WHO 2012) suggests the evaluation of internet provision and telemedicine, as further alternative service delivery channels of safe abortion, as a subject for future research (WHO 2012) Our studies have shown that telemedicine and provision of medical abortion through wow is safe, acceptable and with outcomes similar to medical abortion provided traditionally following face-to-face counselling. Furthermore, recently home self-assessment of the abortion outcome through a low sensitivity U-hCg test was shown to be highly acceptable to women. To evaluate whether counselling through telemedicine is non-inferior to face-to face counselling a RCT will be conducted including women who chose medical abortion up to 63 days of gestation with home administration of misoprostol and self assessment of the outcome. The results of this study could be of major importance to increase access to safe and acceptable abortion services.
- Conditions
- Medical Abortion Counselling
- Being tested
- Telemedicine counselling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine counsellingOther
women on web counselling
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine counselling | Other | intervention group Women who will receive telemedicine counselling Receives: Other: Telemedicine counselling |
| Standard care | No intervention | Women who will receive standard face-to-face counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women with complete abortion
Efficacy of medical abortion defined as complete abortion without ongoing intrauterine pregnancy or surgical intervention for incomplete abortion within 30 days of the abortion treatment.Reported by the patient in the follow up questionnaire and by assessment of patient records
Measured: 30 days of abortion treatment
Secondary outcomes (2)
Rate of reported complications that require additional treatment.
complications defined as; infection, bleeding Reported at follow up or
Measured: 30 days
Proportions of women who would chose the same mode of provision in case of a future medical abortion
satisfaction with mode of counselling. Follow up questionnaire
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start4 Apr 2018
- Primary completion31 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Abortion CounsellingStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised trial
- Masking
- None (open label)
- Enrolment
- 1,598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Gemzell Danielsson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461653
- Sponsor's protocol ID
- wow2018
- Status last verified
- Apr 2025
- First submitted
- 28 Feb 2018
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Medical Abortion Through Telemedicine Versus Standard Provision - a Randomised Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT03461653
- Acronym / sponsor ID
- wow2018
- Conditions
- Medical Abortion Counselling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,598 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 12 Mar 2018 (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 guidance on Safe abortion technology by the World Health Organization (WHO 2012) suggests the evaluation of internet provision and telemedicine, as further alternative service delivery channels of safe abortion, as a subject for future research (WHO 2012) Our studies have shown that telemedicine and provision of medical abortion through wow is safe, acceptable and with outcomes similar to medical abortion provided traditionally following face-to-face counselling. Furthermore, recently home self-assessment of the abortion outcome through a low sensitivity U-hCg test was shown to be highly acceptable to women. To evaluate whether counselling through telemedicine is non-inferior to face-to face counselling a RCT will be conducted including women who chose medical abortion up to 63 days of gestation with home administration of misoprostol and self assessment of the outcome. The results of this study could be of major importance to increase access to safe and acceptable abortion services.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised trial
| Arm | Type | Receives |
|---|---|---|
| Telemedicine counselling | Other | Other: Telemedicine counsellingintervention group Women who will receive telemedicine counselling |
| Standard care | No intervention | –Women who will receive standard face-to-face counselling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- requesting termination of pregnancy by means of mifepristone followed by home administration of misoprostol at < /=63 days of gestation, no contraindication to medical abortion and self administration of misoprostol at home, and who have given their informed consent
Key exclusion criteria (1 listed)
- women who do not want home administration of misoprostol, women who are unable to communicate in Swedish, or English, and women with symptoms and signs of ectopic pregnancy.
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 |
|---|---|---|
| Telemedicine counsellingwomen on web counselling | Other | Telemedicine counselling |
Primary outcome
Proportion of women with complete abortion
Time frame: 30 days of abortion treatment
Efficacy of medical abortion defined as complete abortion without ongoing intrauterine pregnancy or surgical intervention for incomplete abortion within 30 days of the abortion treatment.Reported by the patient in the follow up questionnaire and by assessment of patient records
2 secondary outcomes
Rate of reported complications that require additional treatment.
Time frame: 30 days
Proportions of women who would chose the same mode of provision in case of a future medical abortion
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine counselling in people with Medical Abortion Counselling, run by Karolinska Institutet at 1 site in Sweden.
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 1 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: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women with complete abortion (time frame: 30 days of abortion treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.