A comparison of oral misoprostol with vaginal misoprostol administration in second-trimester pregnancy termination for fetal abnormality.
OBJECTIVE
To compare the clinical efficacy and side effects of oral misoprostol with vaginal misoprostol for second-trimester pregnancy termination.


METHODS
A randomized clinical trial of medical pregnancy termination between 14 and 26 weeks' gestation was conducted. Three misoprostol regimens were compared: 400 microg vaginally at 6-hour intervals (group 1), 400 microg orally at 3-hour intervals (group 2), and a loading dose of 600 microg vaginally followed by 200 microg orally at 3-hour intervals (group 3). A sample size of 225 women was required for equivalence of the three regimens, with an interim safety analysis planned at 80 women.


RESULTS
A significant difference between the groups was evident at the interim safety analysis and the study ceased. The subset of 84 women recruited before the study closure is described. There was a significant difference in the median time to achieve delivery among the three groups: group 1, 14.5 hours (95% confidence interval 12.0, 16.9), versus group 2, 25.5 hours (13.5, 23.8), versus group 3, 16.4 hours (interquartile range 14.2-37.3) (P =.042). Within 24 hours of commencement 85.7% of women in group 1, 44.8% in group 2, and 74.1% in group 3 delivered (P =.003). At 48 hours 0% in group 1, 20.7% in group 2, and 3.7% in group 3 were undelivered (P =.011). There was no difference in women's perceptions of the termination process.


CONCLUSIONS
In second-trimester pregnancy termination, a vaginal misoprostol regimen of 400 microg every 6 hours was 1.9 times more likely to result in delivery within 24 hours from commencement than an oral regimen of 400 microg every 3 hours.
Dickinson
Jan E
JE
School of Women's and Infants' Health, The University of Western Australia, Perth, Western Australia, Australia. jand@cyllene.edu.au
Evans
Sharon F
SF
D000020:Abortifacient Agents, Nonsteroidal / Q000008:administration & dosage*; D000028:Abortion, Induced / Q000379:methods*; D000282:Administration, Intravaginal; D000284:Administration, Oral; D000328:Adult; D004334:Drug Administration Schedule; D005260:Female; D005333:Fetus / Q000002:abnormalities; D006801:Humans; D016595:Misoprostol / Q000008:administration & dosage*; D011247:Pregnancy; D011262:Pregnancy Trimester, Second; D013997:Time Factors
D000020:Abortifacient Agents, Nonsteroidal; D016595:Misoprostol