Clinical Research Directory

'No-test' Tele-abortion: a Multi-centre Randomised Controlled Trial

Sponsor: Karolinska Institutet

Summary

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.

Official title: Optimising Healthcare Access Through 'No-Test' Tele-Abortion: a Multi-centre Randomised Controlled Trial in Sweden (OPTIMISE)

Key Details

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