Trial Outcomes & Findings for Same-day Dilapan-S With Adjunctive Misoprostol (NCT NCT01818414)

Results Overview

The primary outcome will be operative time. Operative time will be measured from initial passage of an instrument into the uterus to start the D\&E. The end of operative time will be measured by the removal of the last instrument from the uterus to complete the D\&E.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

29 participants

Primary outcome timeframe

Day 1 of the study

Results posted on

2017-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	Misoprostol Misoprostol 400 mcg buccal 3 hours prior to D\&E as an adjunct to same-day Dilapan-S. Misoprostol	Folic Acid Folic acid 4 mg buccally 3 hours prior to D\&E as an adjunct to same-day Dilapan-S Folic Acid
Overall Study STARTED	14	15
Overall Study COMPLETED	14	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Same-day Dilapan-S With Adjunctive Misoprostol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Misoprostol n=14 Participants Misoprostol 400 mcg buccal 3 hours prior to D\&E as an adjunct to same-day Dilapan-S. Misoprostol	Folic Acid n=15 Participants Folic acid 4 mg buccally 3 hours prior to D\&E as an adjunct to same-day Dilapan-S Folic Acid	Total n=29 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	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Gender Female	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 of the study

The primary outcome will be operative time. Operative time will be measured from initial passage of an instrument into the uterus to start the D\&E. The end of operative time will be measured by the removal of the last instrument from the uterus to complete the D\&E.

Outcome measures

Outcome measures
Measure	Misoprostol n=14 Participants Misoprostol 400 mcg buccal 3 hours prior to D\&E as an adjunct to same-day Dilapan-S. Misoprostol	Folic Acid n=15 Participants Folic acid 4 mg buccally 3 hours prior to D\&E as an adjunct to same-day Dilapan-S Folic Acid
Operative Time	11.1 minutes Standard Deviation 5.4	13.5 minutes Standard Deviation 4.0

SECONDARY outcome

Timeframe: Day 1

Change in pain from baseline to immediately preoperatively using a 100-mm Visual Analogue Scale ("100-mm Visual Analogue Scale with 0 indicating "no pain" and 100 indicating "worst pain in my life")

Outcome measures

Outcome measures
Measure	Misoprostol n=14 Participants Misoprostol 400 mcg buccal 3 hours prior to D\&E as an adjunct to same-day Dilapan-S. Misoprostol	Folic Acid n=15 Participants Folic acid 4 mg buccally 3 hours prior to D\&E as an adjunct to same-day Dilapan-S Folic Acid
Patient Pain	43.9 mm Standard Deviation 25.4	24.3 mm Standard Deviation 26.4

SECONDARY outcome

Timeframe: Day 1

Patient postoperative satisfaction with cervical preparation method

Outcome measures

Outcome measures
Measure	Misoprostol n=14 Participants Misoprostol 400 mcg buccal 3 hours prior to D\&E as an adjunct to same-day Dilapan-S. Misoprostol	Folic Acid n=15 Participants Folic acid 4 mg buccally 3 hours prior to D\&E as an adjunct to same-day Dilapan-S Folic Acid
Number of Participants With Postoperative Satisfaction	10 participants	14 participants

SECONDARY outcome

Timeframe: Day 1

Provider overall satisfaction with cervical preparation

Outcome measures

Outcome measures
Measure	Misoprostol n=14 Participants Misoprostol 400 mcg buccal 3 hours prior to D\&E as an adjunct to same-day Dilapan-S. Misoprostol	Folic Acid n=15 Participants Folic acid 4 mg buccally 3 hours prior to D\&E as an adjunct to same-day Dilapan-S Folic Acid
Number of Providers With Overall Satisfaction	10 providers	9 providers

SECONDARY outcome

Timeframe: Day 1

Incidence of surgical complications related to D\&E

Outcome measures

Outcome measures
Measure	Misoprostol n=14 Participants Misoprostol 400 mcg buccal 3 hours prior to D\&E as an adjunct to same-day Dilapan-S. Misoprostol	Folic Acid n=15 Participants Folic acid 4 mg buccally 3 hours prior to D\&E as an adjunct to same-day Dilapan-S Folic Acid
Complications	0 participants	2 participants

Adverse Events

Misoprostol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Comparator: Folic Acid

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Misoprostol n=14 participants at risk Misoprostol 400 mcg buccal 3 hours prior to D\&E as an adjunct to same-day Dilapan-S	Placebo Comparator: Folic Acid n=15 participants at risk Folic acid 4 mg buccally 3 hours prior to D\&E as an adjunct to same-day Dilapan-S
Reproductive system and breast disorders Hemorrhage	0.00% 0/14 • 1 day	6.7% 1/15 • Number of events 1 • 1 day

Other adverse events

Adverse event data not reported

Additional Information

Christy Boraas, MD, MPH

University of Minnesota

Phone: 612-273-7111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place