An interventional study of Home administration of 200 mg mifepristone and Home or clinic administration of 400 mcg buccal misoprostol in Abortion, First Trimester, sponsored by Gynuity Health Projects. Completed at 4 sites in Georgia. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-04-06.
Sponsored by Gynuity Health Projects · Not applicable, Interventional, and Health services research
This study examined the acceptability and feasibility of using a simplified regimen of medical abortion in the eastern and western regions of the country of Georgia. It was hypothesized that home use of mifepristone and buccal administration of misoprostol would be both acceptable and efficacious.
The study recruited women with pregnancies up to 63 days gestation. Eligible women took 200 mg mifepristone. Two days later they took 400 mcg buccal misoprostol, with the option of doing so in the clinic or at home. They underwent clinic follow-up 12-15 days after taking mifepristone to determine if their medical abortions were complete. The study assessed the regimen's efficacy, women's preferences regarding where to administer the medications, and the acceptability of buccal misoprostol and of side effects that accompanied women's medical abortions.
Gynuity Health Projects is the lead sponsor of 112 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Home administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol.
Drug: Home administration of 200 mg mifepristone · Drug: Home or clinic administration of 400 mcg buccal misoprostol
Clinic administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol.
Drug: Home or clinic administration of 400 mcg buccal misoprostol
Home administration of 200 mg mifepristone.
Also known as: Penkrofton
Home or clinic administration of 400 mcg buccal misoprostol
Proportion of abortions that are complete without surgical intervention (unit: percent)
Percentage of women with complete abortion without the need of a surgical intervention.
Time frame: 15 days
Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent)
Woman's satisfaction with her medical abortion procedure and side effects experienced.
Time frame: 15 days
Proportion of women who select home-use of mifepristone
Time frame: 1 week
Proportion of women who select home-use of misoprostol
Time frame: 1 week
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Gynuity Health Projects