Trial Outcomes & Findings for Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women (NCT NCT00886834)

Results Overview

VAS (anchors: 0 = extremely easy, 100 mm= impossible)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

108 participants

Primary outcome timeframe

Immediately post IUD insertion

Results posted on

2014-12-22

Participant Flow

Patients were recruited from July 2009 to November 2010. All IUD insertions occurred at the University of Utah Ob/Gyn clinic.

Participants had an initial study visit where the consent was signed and they were given misoprostol or placebo to take at home. Participants and providers were blinded to the treatment group.

Participant milestones

Participant milestones
Measure	Misoprostol Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.	Placebo Pills which are identical to the study drug in appearance, taste, and smell.
Overall Study STARTED	54	54
Overall Study COMPLETED	54	51
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Misoprostol Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.	Placebo Pills which are identical to the study drug in appearance, taste, and smell.
Overall Study Protocol Violation	0	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Misoprostol n=54 Participants Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.	Placebo n=54 Participants Pills which are identical to the study drug in appearance, taste, and smell.	Total n=108 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	54 Participants n=5 Participants	54 Participants n=7 Participants	108 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	24.6 years STANDARD_DEVIATION 3.8 • n=5 Participants	24.8 years STANDARD_DEVIATION 4.2 • n=7 Participants	24.7 years STANDARD_DEVIATION 4.0 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	54 Participants n=7 Participants	108 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	54 participants n=5 Participants	54 participants n=7 Participants	108 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately post IUD insertion

Population: 2 of the placebo patients received pre-medication for pain and were excluded and 1 of the placebo patients did not return for IUD insertion.

VAS (anchors: 0 = extremely easy, 100 mm= impossible)

Outcome measures

Outcome measures
Measure	Misoprostol n=54 Participants	Placebo n=51 Participants
Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS)	25.1 units on a scale Standard Deviation 3.5	27.4 units on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: prior to insertion, immediately after insertion, and prior to clinic discharge

Population: 2 of the placebo patients received pre-medication for pain and were excluded and 1 of the placebo patients did not return for IUD insertion.

VAS; anchors: 0 =none, 100 mm= worst imaginable

Outcome measures

Outcome measures
Measure	Misoprostol n=54 Participants	Placebo n=51 Participants
Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS) prior to insertion	17.1 units on a scale Standard Deviation 3.5	4.8 units on a scale Standard Deviation 2.0
Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS) immediately after insertion	58.4 units on a scale Standard Deviation 3.3	56.9 units on a scale Standard Deviation 3.0
Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS) prior to clinic discharge	35.1 units on a scale Standard Deviation 3.4	27.5 units on a scale Standard Deviation 2.4

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

Dr. David Turok

University of Utah, Department of Obstetrics and Gynecology

Phone: 801-581-7647

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place