Trial Outcomes & Findings for MiMi: A Randomized Trial of Mifepristone and Misoprostol for Treatment of Early Pregnancy Failure (NCT NCT00468299)

NCT ID: NCT00468299

Last Updated: 2011-07-21

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: 24-48 hrs
• Results posted on: 2011-07-21

Participant Flow

Participant milestones

Measure	Misoprostol and Placebo Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.	Mifepristone and Misoprostol Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
Overall Study STARTED	9	8
Overall Study COMPLETED	9	7
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Misoprostol and Placebo Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.	Mifepristone and Misoprostol Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

MiMi: A Randomized Trial of Mifepristone and Misoprostol for Treatment of Early Pregnancy Failure

Baseline characteristics by cohort

Measure	Misoprostol and Placebo n=9 Participants Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.	Mifepristone and Misoprostol n=8 Participants Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	28 years STANDARD_DEVIATION 4 • n=5 Participants	29 years STANDARD_DEVIATION 4 • n=7 Participants	28 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	8 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 24-48 hrs

Outcome measures

Measure	Misoprostol and Placebo n=9 Participants Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.	Mifepristone and Misoprostol n=8 Participants Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure.	5 participants	5 participants

SECONDARY outcome

Timeframe: 3 weeks

Population: Per protocol

Complete abortion at one week; uterus demonstrated to be empty on transvaginal ultrasound

Outcome measures

Measure	Misoprostol and Placebo n=9 Participants Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.	Mifepristone and Misoprostol n=8 Participants Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
Complete Abortion at One Week	6 participants	7 participants

Adverse Events

Misoprostol and Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mifepristone and Misoprostol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sarah Betstadt

University of Rochester

Phone: 585-276-5368

Email: sarah_betstadt@urmc.rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place