Trial Outcomes & Findings for Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women (NCT NCT01147497)

Results Overview

The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

78 participants

Primary outcome timeframe

assessed immediately post IUD insertion

Results posted on

2018-01-12

Participant Flow

Enrollment occurred at a faculty practice clinic affiliated with Emory University.

Seventy-eight nulliparous women were enrolled, and 71 completed the study. Five dropped out prior to randomization and method insertion choosing other birth control options.

Participant milestones

Participant milestones
Measure	Misoprostol Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit	Placebo Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
Overall Study STARTED	37	36
Overall Study COMPLETED	35	36
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Misoprostol Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit	Placebo Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
Overall Study failed insertion	2	0

Baseline Characteristics

Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Misoprostol n=37 Participants Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit	Placebo n=36 Participants Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit	Total n=73 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=93 Participants	36 Participants n=4 Participants	73 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	26.05 years STANDARD_DEVIATION .554 • n=93 Participants	25.5 years STANDARD_DEVIATION .554 • n=4 Participants	25.775 years STANDARD_DEVIATION .554 • n=27 Participants
Sex: Female, Male Female	37 Participants n=93 Participants	36 Participants n=4 Participants	73 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	37 participants n=93 Participants	36 participants n=4 Participants	73 participants n=27 Participants

PRIMARY outcome

Timeframe: assessed immediately post IUD insertion

The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult).

Outcome measures

Outcome measures
Measure	Misoprostol n=35 Participants Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit	Placebo n=36 Participants Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale	21 units on a scale Interval 0.0 to 100.0	21 units on a scale Interval 0.0 to 68.0

SECONDARY outcome

Timeframe: immediately after insertion

The visual analogue scale for perceived patient pain ranges from 0 (no pain) to 100 (most pain).

Outcome measures

Outcome measures
Measure	Misoprostol n=37 Participants Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit	Placebo n=36 Participants Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
Patient Perceived Pain on a 100 Point Visual Analogue Scale	46 units on a scale Interval 11.0 to 92.0	34 units on a scale Interval 0.0 to 90.0

SECONDARY outcome

Timeframe: assessed immediately after IUD insertion

Outcome measures

Outcome measures
Measure	Misoprostol n=37 Participants Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit	Placebo n=36 Participants Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD	7 participants	3 participants

SECONDARY outcome

Timeframe: assessed immediately after IUD insertion

Population: Data were not collected for this outcome measure. The provider questionnaire developed for this study was piloted prior to study initiation and this question was removed for clarity and to focus on the primary study aims.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: assessed at one week after insertion and at one month after insertion

Population: Data were not collected for this outcome measure. The follow-up participant questionnaires developed for this study were piloted prior to study initiation and this question was removed for clarity, to focus on the primary study aims, and to reduce participant burden.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: assessed immediately following insertion

Population: Data were not collected for this outcome measure. The participant questionnaire developed for this study was piloted prior to study initiation and some questions (including questions about prior pregnancies) were removed for clarity, to focus on the primary study aims, and to reduce participant burden.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: assessed one week after insertion

Population: Data were not collected for this outcome measure. The follow-up questionnaire developed for this study was piloted prior to study initiation and some questions (including questions about medication use) were removed for clarity, to focus on the primary study aims, and to reduce participant burden.

Outcome measures

Outcome data not reported

Adverse Events

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

Eva Lathrop, MD, MPH

Emory University

Phone: 404-778-1379

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place