Article Impact Level: HIGH Data Quality: STRONG Summary of New England Journal of Medicine, 391(18), 1685–1695. https://doi.org/10.1056/NEJMoa2401646 Dr. Karin Brandell et al.
Points
- This study assessed the safety and effectiveness of administering medication abortion before confirming intrauterine pregnancy via ultrasound.
- It involved a randomized controlled trial of 1,504 women, comparing an early-start group receiving immediate treatment with a standard group delaying treatment until confirmation of pregnancy.
- Complete abortion rates were similar between groups: 95.2% for an early start and 95.3% for standard, with a negligible difference of -0.1 percentage points.
- Ectopic pregnancies were reported in 1.3% of the early-start group and 0.8% of the standard group, with a small number of serious adverse events observed in both groups.
- The findings support the noninferiority of early medication abortion, indicating it is as safe and effective as the standard delayed treatment approach within the early gestational period studied.
Summary
This research paper evaluates the efficacy and safety of medication abortion using mifepristone and misoprostol when administered before confirmation of intrauterine pregnancy via ultrasonography. The study was a multicenter, noninferiority, randomized controlled trial involving women requesting medication abortion up to 42 days of gestation, where pregnancies were visualized as an empty cavity or a sac-like structure without a yolk sac or embryonic pole. Participants were randomly assigned to an early-start group, receiving immediate abortion treatment, or a standard group, which delayed treatment until intrauterine pregnancy confirmation. The primary outcome was the rate of complete abortion, with a noninferiority margin set at 3.0 percentage points.
One thousand five hundred four women participated across 26 sites in nine countries, with 754 assigned to the early-start group and 750 to the standard group. The intention-to-treat analysis revealed a complete abortion rate of 95.2% (676 of 710 participants) in the early-start group, compared to 95.3% (656 of 688 participants) in the standard group, resulting in an absolute between-group difference of -0.1 percentage points (95% confidence interval [CI], -2.4 to 2.1). Ectopic pregnancies were reported in 10 of 741 participants (1.3%) in the early-start group and 6 of 724 (0.8%) in the standard group, including one rupture prior to diagnosis in the early-start group. Serious adverse events occurred in 12 of 737 participants (1.6%) in the early-start group versus 5 of 718 (0.7%) in the standard group (P=0.10), predominantly involving uncomplicated hospitalizations for ectopic pregnancy or incomplete abortion.
The study concludes that medication abortion before confirmation of intrauterine pregnancy is non-inferior to standard delayed treatment concerning the rate of complete abortion. This finding supports the safety and efficacy of early administration of medication abortion in the specified gestational timeframe.
Link to the article: https://www.nejm.org/doi/10.1056/NEJMoa2401646
References Brandell, K., Jar-Allah, T., Reynolds-Wright, J., Kopp Kallner, H., Hognert, H., Gyllenberg, F., Kaislasuo, J., Tamang, A., Tuladhar, H., Boerma, C., Schimanski, K., Gibson, G., Løkeland, M., Teleman, P., Bixo, M., Mandrup Kjaer, M., Kallfa, E., Bring, J., Heikinheimo, O., … Gemzell-Danielsson, K. (2024). Randomized trial of very early medication abortion. New England Journal of Medicine, 391(18), 1685–1695. https://doi.org/10.1056/NEJMoa2401646
