The New England Journal of MedicineRandomized Trial of Very Early Medication Abortion

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This study compares the efficacy and safety of immediate versus delayed medication abortion in early pregnancy before ultrasound confirmation of intrauterine pregnancy, addressing a critical knowledge gap in early pregnancy care protocols.

Study Design:

• Multicenter, noninferiority, randomized controlled trial conducted across 26 sites in 9 countries
• 1,504 participants seeking medication abortion at ≤42 days gestation
• Participants had unconfirmed intrauterine pregnancy (empty cavity or sac-like structure without yolk sac/embryonic pole)
• Randomized into early-start group (immediate treatment, n=754) and standard group (delayed until pregnancy confirmation, n=750)
• Primary outcome measure: complete abortion
• Noninferiority margin set at 3.0 percentage points

Key Findings:

• Complete abortion rates: 95.2% (early-start) vs 95.3% (standard), difference -0.1 percentage points
• Ectopic pregnancy rates: 1.3% (early-start) vs 0.8% (standard)
• One ectopic rupture occurred in early-start group
• Serious adverse events: 1.6% (early-start) vs 0.7% (standard), p=0.10
• Most adverse events were uncomplicated hospitalizations for ectopic pregnancy or incomplete abortion treatment

HCN Medical Memo
Although the study demonstrates noninferiority of immediate treatment, clinicians should carefully weigh the small increase in serious adverse events and ectopic pregnancy rates against the benefits of earlier access to care. Protocol modifications may be warranted with enhanced ectopic pregnancy surveillance.

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