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

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ClinicalTrials.gov Identifier: NCT01307111
Recruitment Status : Completed
First Posted : March 2, 2011
Results First Posted : March 28, 2016
Last Update Posted : March 28, 2016
Sponsor:
Information provided by (Responsible Party):
Eve Espey, University of New Mexico

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Misoprostol
Drug: Placebo
Enrollment 85
Recruitment Details 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.
Pre-assignment Details 3 of the 85 enrolled participants were deemed ineligible and not randomized to misoprostol or the placebo group.
Arm/Group Title Misoprostol Placebo
Hide Arm/Group Description

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.

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.

Period Title: IUD Insertion
Started 42 40
Completed 40 40
Not Completed 2 0
Reason Not Completed
Lost to Follow-up             2             0
Period Title: 1-2 Week IUD Check up
Started 40 40
Completed 38 38
Not Completed 2 2
Reason Not Completed
IUD expulsion/removal             2             2
Arm/Group Title Misoprostol Placebo Not Randomized Total
Hide Arm/Group Description Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire. Pills which are identical to the study drug in appearance, taste, and smell. Women not eligible to continue to randomization. Total of all reporting groups
Overall Number of Baseline Participants 42 40 3 85
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 40 participants 3 participants 85 participants
24.1  (4.3) 24.1  (4.6) NA [1]   (NA) 24.1  (4.4)
[1]
Patient data not collected, deemed ineligible after recruitment.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 40 participants 3 participants 85 participants
Female
42
 100.0%
40
 100.0%
3
 100.0%
85
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants 40 participants 3 participants 85 participants
42 40 3 85
1.Primary Outcome
Title Patient Perceived Pain on a 100-point Visual Analogue Scale.
Hide Description 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.
Time Frame Prior to insertion, immediately after insertion, and prior to clinic discharge.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Misoprostol Placebo
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pain perceived prior to insertion 0.5  (1.2) 0.8  (1.7)
Pain perceived immediately after insertion 5.8  (2.0) 5.9  (2.0)
Pain perceived prior to clinic discharge 3.2  (2.2) 3.8  (2.7)
2.Secondary Outcome
Title Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale.
Hide Description Perceived ease of IUD insertion registered on a visual analogue scale (0 = easy, 100 = extremely difficult).
Time Frame Immediately post IUD insertion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Misoprostol Placebo
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.2  (2.2) 2.5  (2.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Misoprostol Placebo
Hide Arm/Group Description 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.
All-Cause Mortality
Misoprostol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Misoprostol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Misoprostol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Eve Espey, MD, MPH, Principle Investigator
Organization: University of New Mexico
Phone: 505-272-6372
Responsible Party: Eve Espey, University of New Mexico
ClinicalTrials.gov Identifier: NCT01307111     History of Changes
Other Study ID Numbers: HRRC #09-426
First Submitted: March 1, 2011
First Posted: March 2, 2011
Results First Submitted: December 16, 2015
Results First Posted: March 28, 2016
Last Update Posted: March 28, 2016