Trial Outcomes & Findings for 24-hour Mifepristone and Buccal Versus Mifepristone and Vaginal Misoprostol for Cervical Preparation for D&E (NCT NCT03134183)

NCT ID: NCT03134183

Last Updated: 2018-07-18

Results Overview

Time from initial uterine instrumentation to speculum out

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 70 participants
• Primary outcome timeframe: At end of procedure
• Results posted on: 2018-07-18

Participant Flow

Participant milestones

Measure	Vaginal Misoprostol Intervention is misoprostol versus placebo 400mcg misoprostol formulated within cocoa butter suppository Vaginal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) vaginally 1-2 hours prior and placebo (buccal mint powder) buccally 1-2 hours prior to D\&E	Buccal Misoprostol Intervention is misoprostol versus placebo 400mcg misoprostol formulated within mint flavored powder Buccal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) ground with mint into buccal powder and placebo (two lactose tablets designed to appear similar to misoprostol) vaginally 1-2 hours prior to D\&E
Overall Study STARTED	36	34
Overall Study COMPLETED	35	33
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Vaginal Misoprostol Intervention is misoprostol versus placebo 400mcg misoprostol formulated within cocoa butter suppository Vaginal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) vaginally 1-2 hours prior and placebo (buccal mint powder) buccally 1-2 hours prior to D\&E	Buccal Misoprostol Intervention is misoprostol versus placebo 400mcg misoprostol formulated within mint flavored powder Buccal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) ground with mint into buccal powder and placebo (two lactose tablets designed to appear similar to misoprostol) vaginally 1-2 hours prior to D\&E
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Vaginal Misoprostol n=35 Participants Intervention is misoprostol versus placebo 400mcg misoprostol formulated within cocoa butter suppository Vaginal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) vaginally 1-2 hours prior and placebo (buccal mint powder) buccally 1-2 hours prior to D\&E	Buccal Misoprostol n=33 Participants Intervention is misoprostol versus placebo 400mcg misoprostol formulated within mint flavored powder Buccal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) ground with mint into buccal powder and placebo (two lactose tablets designed to appear similar to misoprostol) vaginally 1-2 hours prior to D\&E	Total n=68 Participants Total of all reporting groups
Age, Customized 18-24	13 Participants n=35 Participants	16 Participants n=33 Participants	29 Participants n=68 Participants
Age, Customized 25-29	9 Participants n=35 Participants	6 Participants n=33 Participants	15 Participants n=68 Participants
Age, Customized 30-34	4 Participants n=35 Participants	7 Participants n=33 Participants	11 Participants n=68 Participants
Age, Customized 35+	10 Participants n=35 Participants	5 Participants n=33 Participants	15 Participants n=68 Participants
Sex: Female, Male Female	35 Participants n=35 Participants	33 Participants n=33 Participants	68 Participants n=68 Participants
Sex: Female, Male Male	0 Participants n=35 Participants	0 Participants n=33 Participants	0 Participants n=68 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	35 Participants n=35 Participants	33 Participants n=33 Participants	68 Participants n=68 Participants

PRIMARY outcome

Timeframe: At end of procedure

Time from initial uterine instrumentation to speculum out

Outcome measures

Measure	Vaginal Misoprostol n=35 Participants Intervention is misoprostol versus placebo 400mcg misoprostol formulated within cocoa butter suppository Vaginal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) vaginally 1-2 hours prior and placebo (buccal mint powder) buccally 1-2 hours prior to D\&E	Buccal Misoprostol n=33 Participants Intervention is misoprostol versus placebo 400mcg misoprostol formulated within mint flavored powder Buccal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) ground with mint into buccal powder and placebo (two lactose tablets designed to appear similar to misoprostol) vaginally 1-2 hours prior to D\&E
Procedure Time	9.5 minutes Standard Deviation 5	9.9 minutes Standard Deviation 4

SECONDARY outcome

Timeframe: At end of procedure

Pratt Dilator initially accepted without resistance starting from 65 and working down

Outcome measures

Measure	Vaginal Misoprostol n=35 Participants Intervention is misoprostol versus placebo 400mcg misoprostol formulated within cocoa butter suppository Vaginal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) vaginally 1-2 hours prior and placebo (buccal mint powder) buccally 1-2 hours prior to D\&E	Buccal Misoprostol n=33 Participants Intervention is misoprostol versus placebo 400mcg misoprostol formulated within mint flavored powder Buccal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) ground with mint into buccal powder and placebo (two lactose tablets designed to appear similar to misoprostol) vaginally 1-2 hours prior to D\&E
Cervical Dilation	49.6 "French" circumference in millimeters Standard Deviation 10	46.2 "French" circumference in millimeters Standard Deviation 11

Adverse Events

Vaginal Misoprostol

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Buccal 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

Measure	Vaginal Misoprostol n=36 participants at risk；n=35 participants at risk Intervention is misoprostol versus placebo 400mcg misoprostol formulated within cocoa butter suppository Vaginal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) vaginally 1-2 hours prior and placebo (buccal mint powder) buccally 1-2 hours prior to D\&E	Buccal Misoprostol n=34 participants at risk；n=33 participants at risk Intervention is misoprostol versus placebo 400mcg misoprostol formulated within mint flavored powder Buccal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) ground with mint into buccal powder and placebo (two lactose tablets designed to appear similar to misoprostol) vaginally 1-2 hours prior to D\&E
Pregnancy, puerperium and perinatal conditions Expulsion	2.8% 1/36 • Number of events 1 • 1 year	0.00% 0/34 • 1 year

Additional Information

Frances Casey, MD

Virginia Commonwealth University

Phone: 804-828-5076

Email: frances.casey@vcuhealth.org

Results disclosure agreements

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