Photo Credit: wayhomestudio

The following is a summary of “Randomized Trial of Very Early Medication Abortion,” published in the November 2024 issue of Obstetrics and Gynecology by Brandell et al.  

Medication abortion involving mifepristone and misoprostol is highly effective and safe, though evidence is limited regarding the use in very early pregnancies before ultrasound confirmation of intrauterine pregnancy (IUP).  

Researchers conducted a prospective study comparing the efficacy and safety of very early medication abortion to standard delayed treatment.  

They conducted a multicenter, randomized, controlled trial (RCT) in 9 countries, enrolling 1,504 participants seeking medication abortion at up to 42 days of gestation without confirmed IUP (visualized as an empty cavity or sac-like structure without a yolk sac or embryonic pole). Participants were randomized to an early-start group or a standard delayed-treatment group. Primary outcome was the rate of complete abortion, with a noninferiority margin of 3.0 percentage points.  

The results showed a complete abortion occurred in 95.2% (676 of 710) of participants in the early-start group and 95.3% (656 of 688) in the standard group, with an absolute difference of −0.1 percentage points (95% CI, −2.4 to 2.1). Ectopic pregnancies occurred in 1.3% (10 of 741) of participants in the early-start group and 0.8% (6 of 724) in the standard group, including one rupture before diagnosis (early-start group). Serious AEs were reported in 1.6% (12 of 737) of the early-start group and 0.7% (5 of 718) of the standard group (P=0.10), primarily due to hospitalizations for ectopic pregnancy or incomplete abortion.  

They concluded that very early medication abortion without confirmed IUP was as effective as standard delayed treatment.  

Source: nejm.org/doi/full/10.1056/NEJMoa2401646