Medical Professionals Reference (MPR)New Copper IUD Miudella Approved for Pregnancy Prevention

This single-arm, open-label trial (NCT03633799) evaluated a novel hormone-free copper IUD in 1,601 women aged 17-45 years. The 3-year study demonstrates moderate-quality evidence for efficacy with a cumulative Pearl Index of 1.05 (95% CI, 0.66-1.60), representing a new option in the limited field of non-hormonal intrauterine contraception.

⚕️Key Clinical Considerations⚕️

• The 3-year Pearl Index of 1.05 indicates reliable contraceptive efficacy comparable to existing copper IUDs but with less than half the copper dose (175mm² vs. 380mm² in ParaGard).
• High placement success rate (98.8%) with preloaded inserter design may simplify the procedure for clinicians compared to devices requiring loading.
• Rapid return to fertility demonstrated, with 74.1% of users conceiving within 12 months after removal when pregnancy was desired.
• Year-specific Pearl Indices varied (Year 1: 0.94, Year 2: 1.60, Year 3: 0.60), suggesting possible fluctuations in efficacy during the 3-year lifespan.
• Common adverse effects remain similar to other copper IUDs: heavy menstrual bleeding, dysmenorrhea, and intermenstrual bleeding, warranting thorough pre-insertion counseling.

🎯 Clinical Practice Impact 🎯

• Miudella offers an important addition to non-hormonal contraceptive options with its lower copper dose potentially affecting bleeding profiles and patient tolerability.
• The preloaded design simplifies insertion, which may expand provider comfort with placement.
• When counseling patients, emphasize the 3-year duration (versus 10+ years for ParaGard), Boxed Warning regarding improper insertion risks, and the consistent safety profile.
• Consider Miudella particularly for patients seeking shorter-term, hormone-free contraception who have experienced heavy bleeding with higher-dose copper IUDs.

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