Prospective cohort study evaluates medical abortion effectiveness before confirmed IUP, suggesting safety for early treatment.
INTRODUCTION: Medical abortion using mifepristone and misoprostol is effective and safe, but evidence is limited in very early gestation before ultrasound confirmation of an intrauterine pregnancy (IUP). METHODS: This single-centre prospective cohort study included 100 women between 2023 and 2025 who requested medical abortion up to 6+0 weeks of gestation and had a non-confirmed IUP on ultrasound (empty cavity or sac-like structure without embryonic pole). Participants initiated immediate medical abortion according to the WHO-recommended protocol. The primary outcome was complete abortion without the need for surgical intervention. RESULTS: Complete abortion was achieved in 95% of the participants without the need for surgical intervention. The ectopic pregnancy rate was 2%, all of which were diagnosed before rupture. 2% required additional medical treatment, and 2% surgical intervention. No serious adverse events occurred. CONCLUSIONS: Medical abortion before visible IUP is as effective as standard treatment. Very early medical abortion can be implemented safely and effectively with structured follow-up, allowing for earlier treatment without compromising safety. FUNDING: None. TRIAL REGISTRATION: The study was approved by the University Hospital of Southern Denmark, Sygehus Sønderjylland, record no.:24/44840.
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