'No-test' Tele-abortion: a Multi-centre Randomised Controlled Trial
ConditionMedical Abortion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorKarolinska Institutet
About this trial
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:
* Is no-test telemedicine medical abortion (without routine ultrasound) as effective as standard clinic-based medical abortion (with routine ultrasound) in achieving complete abortion? * Is no-test telemedicine medical abortion as safe, acceptable, and cost-effective as standard clinic-based medical abortion? Researchers will compare no-test telemedicine medical abortion to standard clinic-based medical abortion to determine whether the telemedicine model results in similar effectiveness and safety outcomes while improving access to care.
Participants will:
* Be randomly assigned to receive either no-test telemedicine medical abortion or standard clinic-based medical abortion. * Receive counseling and clinical assessment according to their assigned care model. * Use medical abortion treatment at home. * Complete follow-up assessments approximately 6 weeks after the abortion. * Provide information about treatment outcomes, complications, healthcare contacts, satisfaction with care, and contraceptive use.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant less than or equal to 10+0 weeks according to date for the LMP
Age ≥18 years
Wiling to perform MA at home
Regular menses prior to this pregnancy
Disqualifiers
Contraindications to MA (known allergy to mifepristone or misoprostol)
Health condition requiring in-clinic abortion
Uncertainty around the dates for LMP,
Hormonal contraception used < 3 months
Trial design
Design model
Parallel
Treatments tested in this trial
no-test medical abortion
Other intervention'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.
Standard Care (in control arm)
Other interventionStandard 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.
Treatment groups
978 Participants
are divided into 2 treatment groupsGroup A: No-test tele-abortionExperimental treatment 1 intervention
Group B: Standard care medical abortionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 intakeSecondary outcomes
1
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 intake2
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 intake3
Ectopic pregnancy
Ectopic pregnancy: time to diagnosis from study inclusion (days,hours)
Time frame
42 days following mifepristone intake4
Ectopic pregnancy
Ectopic pregnancy: complication such as rupture (yes/no)
Time frame
42 days following mifepristone intakeOther outcomes
1
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 intake2
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 intake3
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)4
Access: Travel time
Travel time to access medications (hours and minutes)
Time frame
42 days following mifepristone intakeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Region Stockholm
Collaborator
Region Jämtland Härjedalen
Collaborator
Region Västerbotten
Collaborator
Region Norrbotten
Collaborator
Region Örebro County
Collaborator
Source ClinicalTrials.gov
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