CLINICAL QUESTION

Is medication abortion prior to confirmation of intrauterine pregnancy safe and effective?

BOTTOM LINE

Early medication abortion was as effective for complete abortion as delaying treatment until intrauterine pregnancy is confirmed. The reason for failed abortion differed between groups; ongoing pregnancy was more likely in the early abortion group, and surgical intervention was needed more often in the standard care group. (Level of Evidence = 1b–)

SYNOPSIS

Swedish researchers led an international team that recruited women who were seeking medication abortion for a suspected, but unconfirmed, early pregnancy at 26 sites in nine countries. To be included, the women had to have an empty sac or a sac-like structure without an embryonic pole or yolk sac on vaginal ultrasonography. They were randomized to receive early medication abortion immediately after enrollment or medication abortion after confirmation of intrauterine pregnancy (standard care). Women in the standard care group had repeat ultrasonography at 7 days and, if necessary, at 14 days to confirm the pregnancy. If the pregnancy was not confirmed at 14 days, the women were considered to have a pathologic pregnancy (eg, early pregnancy loss, ectopic pregnancy); those women were referred for care but stayed in the study. A total of 1,504 women were randomized, groups were similar at baseline, and analysis was by intention to treat. The mean age was 29.6 years, mean body mass index was 24.9 kg/m², and 60% of the women had experienced three or more pregnancies (including this one). It was the first pregnancy for 23% of the participants. The primary outcome was the rate of complete abortion, which was slightly more than 95% for both groups. Surgical intervention for incomplete abortion was less common in the early abortion group (1.8% vs 4.5%; number needed to treat = 37). There was 1 fewer day of bleeding and higher satisfaction with care in the early abortion group. Ongoing pregnancy was more common in the early abortion group (3.0% vs 0.1%; number needed to treat = 34).