Trial Outcomes & Findings for Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women (NCT NCT01307111)

Results Overview

Perceived pain was registered on a 100-point visual analogue scale (0 = no pain, 100 = worst pain imaginable) at three time points: prior to IUD insertion, immediately after insertion, and prior to clinic discharge.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

85 participants

Primary outcome timeframe

Prior to insertion, immediately after insertion, and prior to clinic discharge.

Results posted on

2016-03-28

Participant Flow

The study design is double-blind randomized controlled trial in which nulliparous women requesting an IUD were randomized to 400 mcg of buccal misoprostol or placebo 2-8 hours before insertion.

3 of the 85 enrolled participants were deemed ineligible and not randomized to misoprostol or the placebo group.

Participant milestones

Participant milestones
Measure	Misoprostol Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire. Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.	Placebo Pills which are identical to the study drug in appearance, taste, and smell. Placebo: Pills which are identical to the study drug in appearance, taste, and smell.
IUD Insertion STARTED	42	40
IUD Insertion COMPLETED	40	40
IUD Insertion NOT COMPLETED	2	0
1-2 Week IUD Check up STARTED	40	40
1-2 Week IUD Check up COMPLETED	38	38
1-2 Week IUD Check up NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Misoprostol Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire. Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.	Placebo Pills which are identical to the study drug in appearance, taste, and smell. Placebo: Pills which are identical to the study drug in appearance, taste, and smell.
IUD Insertion Lost to Follow-up	2	0
1-2 Week IUD Check up IUD expulsion/removal	2	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Misoprostol n=42 Participants Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire.	Placebo n=40 Participants Pills which are identical to the study drug in appearance, taste, and smell.	Not Randomized n=3 Participants Women not eligible to continue to randomization.	Total n=85 Participants Total of all reporting groups
Age, Continuous	24.1 years STANDARD_DEVIATION 4.3 • n=5 Participants	24.1 years STANDARD_DEVIATION 4.6 • n=7 Participants	NA years STANDARD_DEVIATION NA • n=5 Participants	24.1 years STANDARD_DEVIATION 4.4 • n=4 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	40 Participants n=7 Participants	3 Participants n=5 Participants	85 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	42 participants n=5 Participants	40 participants n=7 Participants	3 participants n=5 Participants	85 participants n=4 Participants

PRIMARY outcome

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

Perceived pain was registered on a 100-point visual analogue scale (0 = no pain, 100 = worst pain imaginable) at three time points: prior to IUD insertion, immediately after insertion, and prior to clinic discharge.

Outcome measures

Outcome measures
Measure	Misoprostol n=40 Participants Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.	Placebo n=40 Participants Placebo: Pills which are identical to the study drug in appearance, taste, and smell.
Patient Perceived Pain on a 100-point Visual Analogue Scale. Pain perceived prior to insertion	0.5 units on a scale Standard Deviation 1.2	0.8 units on a scale Standard Deviation 1.7
Patient Perceived Pain on a 100-point Visual Analogue Scale. Pain perceived immediately after insertion	5.8 units on a scale Standard Deviation 2.0	5.9 units on a scale Standard Deviation 2.0
Patient Perceived Pain on a 100-point Visual Analogue Scale. Pain perceived prior to clinic discharge	3.2 units on a scale Standard Deviation 2.2	3.8 units on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: Immediately post IUD insertion

Perceived ease of IUD insertion registered on a visual analogue scale (0 = easy, 100 = extremely difficult).

Outcome measures

Outcome measures
Measure	Misoprostol n=40 Participants Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.	Placebo n=40 Participants Placebo: Pills which are identical to the study drug in appearance, taste, and smell.
Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale.	2.2 units on a scale Standard Deviation 2.2	2.5 units on a scale Standard Deviation 2.2

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

Eve Espey, MD, MPH, Principle Investigator

University of New Mexico

Phone: 505-272-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place