Trial Outcomes & Findings for Misoprostol With Intrauterine Device Insertion (NCT NCT00613366)

Results Overview

Provider ease of insertion was measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0="No Pain" (furthest point to the left) to 100="Worst Pain of My Life" (furthest point to the right).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Time of IUD insertion

Results posted on

2013-03-15

Participant Flow

February 2007-March 2010 in general OB/GYN clinic at an academic hospital

Women desiring IUD placement who were nulliparous were enrolled.

Participant milestones

Participant milestones
Measure	Active Drug (Misoprostol) 400mcg of buccal misoprostol 90 minutes prior to IUD insertion	Placebo Placebo buccal 90 minutes prior to IUD insertion.
Overall Study STARTED	20	20
Overall Study COMPLETED	17	18
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Drug (Misoprostol) 400mcg of buccal misoprostol 90 minutes prior to IUD insertion	Placebo Placebo buccal 90 minutes prior to IUD insertion.
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

Misoprostol With Intrauterine Device Insertion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Drug (Misoprostol) n=20 Participants 400mcg of buccal misoprostol 90 minutes prior to IUD insertion	Placebo n=20 Participants Placebo buccal 90 minutes prior to IUD insertion.	Total n=40 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	20 Participants n=5 Participants	20 Participants n=7 Participants	40 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	25 years STANDARD_DEVIATION 5 • n=5 Participants	27 years STANDARD_DEVIATION 6 • n=7 Participants	26 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	40 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	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Time of IUD insertion

Population: Intent to Treat (ITT)

Provider ease of insertion was measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0="No Pain" (furthest point to the left) to 100="Worst Pain of My Life" (furthest point to the right).

Outcome measures

Outcome measures
Measure	Active Drug (Misoprostol) n=17 Participants 400mcg of buccal misoprostol 90 minutes prior to IUD insertion	Placebo n=18 Participants Placebo buccal 90 minutes prior to IUD insertion.
The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS).	24 mm Standard Deviation 19	29 mm Standard Deviation 21

SECONDARY outcome

Timeframe: At time of IUD insertion

Population: ITT

Perceived pain measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0="No Pain" (furthest point to the left) to 100="Worst Pain of My Life" (furthest point to the right).

Outcome measures

Outcome measures
Measure	Active Drug (Misoprostol) n=17 Participants 400mcg of buccal misoprostol 90 minutes prior to IUD insertion	Placebo n=18 Participants Placebo buccal 90 minutes prior to IUD insertion.
Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS).	65 mm Standard Deviation 21	55 mm Standard Deviation 21

Adverse Events

Active Drug (Misoprostol)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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. Alison Edelman

Oregon Health & Science University

Phone: 503.494.5949

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place