Oral Mifepristone and Buccal Misoprostol Administered Simultaneously for Abortion Through 63 Days Gestation
Status:
Completed
Trial end date:
2006-08-01
Target enrollment:
Participant gender:
Summary
HYPOTHESIS: For women with pregnancies at <49, 50-56, and 57-63 days gestation who receive
mifepristone 200 mg orally and misoprostol 800 mcg buccally at the same time, the complete
abortion rate 24 hours after misoprostol administration will be 90% (95% CI 78%, 97%) within
each gestational age group.
This is a prospective clinical trial. Women will be enrolled such that 40 women are in each
of three gestational age ranges: ≤49, 50-56, and 57-63 days gestation on the day treatment is
initiated. Once a gestational age range includes 40 subjects, enrollment in that group will
be closed. Subjects will swallow mifepristone 200 mg and then place four 200 µg misoprostol
tablets between the check and gum (2 tablets on each side). The women will be instructed to
keep the tablets in place for 30 minutes; any remaining portions of the tablets will be
swallowed after this time. Participants will follow-up 24 hours after receiving the
misoprostol. Vaginal ultrasonography will be performed to assess for expulsion of the
gestational sac. Women who have not aborted by the first follow-up visit will be given a dose
of vaginal misoprostol and will return for a follow-up visit in one week. Subjects who have
not aborted by the two-week follow-up will be offered a surgical abortion. At each visit,
data will be collected on bleeding, cramping, other side effects, and medication use.