An interventional study of no-test medical abortion and Standard Care (in control arm) in Medical Abortion, sponsored by Karolinska Institutet. Not yet recruiting at 10 sites in Sweden. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
Brief Summary The goal of this clinical trial is to learn whether a no-test telemedicine medical abortion model can provide abortion care that is as effective and safe as standard clinic-based medical abortion care among women aged 18 years and older with an early pregnancy who wish to have a medical abortion at home.
The main questions it aims to answer are:
Participants will:
This study will enroll 978 women across five healthcare regions in Sweden. The results will inform future evidence-based guidelines for medical abortion care and may improve access to abortion services, particularly for individuals living in rural and underserved areas.
Karolinska Institutet is the lead sponsor of 1,145 studies on the registry; 274 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
'No-test' tele-abortion (intervention arm)
Other: no-test medical abortion
Standard care (control arm)
Other: Standard Care (in control arm)
'No-test' tele-abortion i.e., medical abortion delivered via telecommunications (phone and web-based) and the medical abortion self-managed at home. Prior in clinic-visit with routine testing (ultrasound, pelvic exam) is omitted and the eligibility assessment is history-based. To meet current legal requirements, mifepristone is taken during a brief in-clinic pick-up visit of a medical abortion kit.
Also known as: teleabortion
Standard care defined as in-clinic provision of medical abortion, delivered during one in-clinic consultation with routine testing (ultrasound, pelvic exam), information provision and mifepristone-intake, followed by misoprostol intake at home.
Complete abortion
Effectiveness of 'no-test' tele-abortion, measured in the proportion of complete abortion with no ongoing pregnancy or surgical intervention for incomplete abortion, within 42 days of the medical abortion (mifepristone intake).
Time frame: 42 days following mifepristone intake
Additional abortion treatment
Any additional treatment the participant has received to complete the abortion including medical (misoprostol or mifepristone and misoprostol) or surgical (uterine aspiration) treatment
Time frame: 42 days following mifepristone intake
Rates of complications
Rates of complications: incomplete abortion, ongoing pregnancy, surgical intervention, infection requiring treatment, ectopic pregnancy not requiring surgery (Adverse Events) and hospitalisation ≥24 hours, blood transfusion, ectopic pregnancy requiring surgery, deaths (Serious Adverse Events).
Time frame: 42 days following mifepristone intake
Ectopic pregnancy
Ectopic pregnancy: time to diagnosis from study inclusion (days,hours)
Time frame: 42 days following mifepristone intake
Ectopic pregnancy
Ectopic pregnancy: complication such as rupture (yes/no)
Time frame: 42 days following mifepristone intake
Ectopic pregnancy
Ectopic pregnancy: S-hcg level at diagnosis
Time frame: 42 days following mifepristone intake
Ectopic pregnancy
Ectopic pregnancy: treatment (expectant management, medical treatment, surgical treatment)
Time frame: 42 days following mifepristone intake
Gestational age at treatment
Gestational length at time of initiating treatment (mifepristone intake). Measured in weeks and days (by dates for the Last Menstrual Period (LMP) and ultrasound when available). LMP collected at baseline, date of mifepristone collected at the follow-up survey. Ultrasound dating collected from the endline review of medical records.
Time frame: LMP collected at baseline. Date of mifepristone collected at the follow-up survey. Ultrasound dating collected from the endline review of medical records (42 days following abortion (mifepristone intake).
Underestimation of gestational age
Proportion of underestimation (\>10+0 weeks) of gestational age detected on ultrasound (LMP at baseline vs ultrasound findings).
Time frame: 42 days following mifepristone intake
Severe pain
Pain defined as Numeric Rating Scale (NRS) \>7
Time frame: 42 days following mifepristone intake
Bleeding days
Number of days bleeding (requiring a pad or similar)
Time frame: 42 days following mifepristone intake
Bleeding amount
Bleeding in relation to menstruation (more/similar or less than a normal menstruation) measured at the follow-up survey.
Time frame: 42 days following mifepristone intake
Access: time to accessing treatment
Time to accessing treatment (from inclusion in the study to the pick-up visit/in-clinic visit; days).
Time frame: 42 days following mifepristone intake
Access: Travel time to access treatment
Travel time to access abortion medications. Measured in hours and minutes
Time frame: 42 days following mifepristone intake
Access: Time to initiating treatment
Time to initiating treatment (from inclusion in the study to mifepristone intake; days)
Time frame: 42 days following mifepristone intake
Postabortion contraceptive use
Measured in use at follow-up categorised as Long-Acting Reversible Contraception (LARC), Short Acting Reversible Contraception (SARC), barrier methods, natural family planning methods (NPF), sterilization and emergency contraception
Time frame: 42 days of the medical abortion (mifepristone intake)
Satisfaction with care
Short Assessment of Patient Satisfaction Scale (SAPS). The SAPS scale contains 7 questions with 5 response options scored 0-4: very satisfied; satisfied; neither satisfied nor dissatisfied; dissatisfied; very dissatisfied. The questions assess satisfaction with: 1. the effectiveness of treatment 2. information provision 3. technical skills of the healthcare provider 4. involvement in decision-making 5. the patient-provider interaction 6. time with the healthcare provider 7. overall, with the care received
Time frame: 42 days of the medical abortion (mifepristone intake)
Satisfaction with care
Overall satisfaction with care using a likert scale
Time frame: 42 days following mifepristone intake
Satisfaction with care
Whether the participant would choose the same model of care again in case of wanting another abortion in the future
Time frame: 42 days following mifepristone intake
Satisfaction with care
Whether the participant would recommend the model of care received to a friend
Time frame: 42 days following mifepristone intake
Satisfaction with information
Satisfaction with information sources using a likert scale (5 options)
Time frame: 42 days following mifepristone intake
Testing
Testing done in-clinic; yes/no; type of tests (ultrasound/pelvic exam/blood-hCG/urine-hCG/STI-testing) and timing (before or after treatment)
Time frame: 42 days following mifepristone intake
Additional contacts
Number of contacts defined as all contacts: (number of contacts; type of contacts (in-clinic/remote), timing of contacts (before/after treatment) and location (emergency gynaecological department; abortion clinic
Time frame: 42 days following mifepristone intake
Access: Distance to abortion clinic
Distance to nearest abortion clinic with emergency care. Calculated using participants postal code and nearest abortion clinic (km)
Time frame: At baseline (postal code) and 42 days following mifepristone intake (abortion clinic)
Access: Travel time
Travel time to access medications (hours and minutes)
Time frame: 42 days following mifepristone intake
Main mode of transport
Main mode of transport (public transport/car/bike/walking)
Time frame: 42 days following mifepristone uptake
Productivity loss
Time off from work as a result of the abortion including attending visits and contacts with healthcare providers, undergoing the abortion.
Time frame: 42 days following mifepristone intake
Quality of Life
Quality of Life will be assessed using the EQ-5D scale. Conversion of scores to Quality-Adjusted Life Years (QALYs)
Time frame: At baselina and 42 days following mifepristone intake
Information sources
Main information sources used to obtain information about 1) the abortion process and 2) postabortion contraception
Time frame: 42 days following mifepristone intake
Plan to share: Yes — IPD Sharing Plan Individual participant data that underlie the results reported in publications arising from this study, after de-identification, will be made available. Data shared will include participant-level data necessary to reproduce the published findings. Supporting Information Available Study protocol, statistical analysis plan, and data dictionary.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will become available 12 months after publication of the primary study results and remain available for 5 years thereafter.
Access criteria: Access to de-identified participant-level data will be considered on a case-by-case basis. Requests must be accompanied by a detailed research proposal and evidence of appropriate ethical approval where applicable. Data sharing is subject to approval by the sponsor, execution of a data sharing agreement, and compliance with GDPR and Swedish legislation. The study investigators reserve the right to decline requests that are not scientifically justified, are not feasible, conflict with participant consent, or cannot be accommodated within regulatory requirements.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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