VEMA
Trial question
Is early-start medication abortion noninferior to standard-care delayed medication abortion in women with unconfirmed intrauterine pregnancy?
Study design
Multi-center
Open label
RCT
Population
1465 female patients.
Inclusion criteria: women requesting medication abortion at up to 42 days of gestation with an unconfirmed intrauterine pregnancy on ultrasound examination.
Key exclusion criteria: symptoms and signs of pathologic pregnancy; risk factors for ectopic pregnancy; any contraindications to medication abortion.
Interventions
N=741 early-start medication abortion (immediate start of abortion with mifepristone and misoprostol).
N=724 standard care delayed medication abortion (delayed abortion until intrauterine pregnancy was confirmed).
Primary outcome
Complete abortion
95.2%
95.3%
95.3 %
71.5 %
47.6 %
23.8 %
0.0 %
Early-start medication
abortion
Standard care delayed medication
abortion
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in complete abortion (95.2% vs. 95.3%; RR 1, 95% CI 0.98 to 1.02).
Secondary outcomes
No significant difference in additional abortion treatment (7% vs. 8.8%; RR 0.8, 95% CI 0.55 to 1.16).
Significant decrease in median number of bleeding days (5 days vs. 6 days; MD -1, 95% CI -1.6 to -0.4).
No significant difference in severe pain (20.1% vs. 24.8%; RR 0.81, 95% CI 0.65 to 1.01).
Safety outcomes
No significant differences in ectopic pregnancies, serious adverse events.
Conclusion
In women requesting medication abortion at up to 42 days of gestation with an unconfirmed intrauterine pregnancy on ultrasound examination, early-start medication abortion was noninferior to standard care delayed medication abortion with respect to complete abortion.
Reference
Karin Brandell, Tagrid Jar-Allah, John Reynolds-Wright et al. Randomized Trial of Very Early Medication Abortion. N Engl J Med. 2024 Nov 7;391(18):1685-1695.
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