Oral Mifepristone and Buccal Misoprostol Administered Simultaneously for Abortion Through 63 Days Gestation
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Oral Mifepristone and Buccal Misoprostol Administered Simultaneously for Abortion Through 63 Days Gestation|
- To determine the complete abortion rate, at 24 hours after misoprostol administration, when using mifepristone 200 mg orally and misoprostol 800 mcg buccally simultaneously in women at <49, 50-56, and 57-63 days gestation.
- To compare the complete abortion rates, at 24 hours after misoprostol administration, by gestational age (up to and including 49, from 50-56, and 57-63 days gestation) with this medical abortion regimen.
- To determine the complete medical abortion rate at approximately 14 days after treatment, among those women who receive a second dose of misoprostol.
- To assess side effects (i.e. nausea, vomiting) and pain medication use after treatment.
- To assess the acceptability of this medical abortion regimen.
- To compare the accuracy of transvaginal and abdominal ultrasonography in gestational age dating and treatment failure in this cohort.
|Study Start Date:||March 2006|
|Estimated Study Completion Date:||August 2006|
|United States, Pennsylvania|
|Office of Family Planning Research, Magee-Womens Hospital|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Patricia A. Lohr, MD||University of Pittsburgh|