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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eve Espey, University of New Mexico
ClinicalTrials.gov Identifier:
NCT01307111
First received: March 1, 2011
Last updated: March 9, 2016
Last verified: February 2016
Results First Received: December 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Pain
Interventions: Drug: Misoprostol
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
3 of the 85 enrolled participants were deemed ineligible and not randomized to misoprostol or the placebo group.

Reporting Groups
  Description
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.


Participant Flow for 2 periods

Period 1:   IUD Insertion
    Misoprostol     Placebo  
STARTED     42     40  
COMPLETED     40     40  
NOT COMPLETED     2     0  
Lost to Follow-up                 2                 0  

Period 2:   1-2 Week IUD Check up
    Misoprostol     Placebo  
STARTED     40     40  
COMPLETED     38     38  
NOT COMPLETED     2     2  
IUD expulsion/removal                 2                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Misoprostol Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire.
Placebo Pills which are identical to the study drug in appearance, taste, and smell.
Not Randomized Women not eligible to continue to randomization.
Total Total of all reporting groups

Baseline Measures
    Misoprostol     Placebo     Not Randomized     Total  
Number of Participants  
[units: participants]
  42     40     3     85  
Age  
[units: years]
Mean (Standard Deviation)
  24.1  (4.3)     24.1  (4.6)     NA [1]   24.1  (4.4)  
Gender  
[units: participants]
       
Female     42     40     3     85  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     42     40     3     85  
[1] Patient data not collected, deemed ineligible after recruitment.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Patient Perceived Pain on a 100-point Visual Analogue Scale.   [ Time Frame: Prior to insertion, immediately after insertion, and prior to clinic discharge. ]

2.  Secondary:   Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale.   [ Time Frame: Immediately post IUD insertion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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
e-mail: eespey@salud.unm.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eve Espey, University of New Mexico
ClinicalTrials.gov Identifier: NCT01307111     History of Changes
Other Study ID Numbers: HRRC #09-426
Study First Received: March 1, 2011
Results First Received: December 16, 2015
Last Updated: March 9, 2016
Health Authority: United States: Food and Drug Administration