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Intra Uterine Device Insertion in Nulliparous Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01422226
Recruitment Status : Terminated (Unable to recruit participants)
First Posted : August 23, 2011
Results First Posted : February 26, 2015
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Contraception
Interventions Drug: Misoprostol
Other: Placebo
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Experimental Active Comparator Placebo Comparator
Hide Arm/Group Description Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
Period Title: Overall Study
Started 1 2
Completed 1 2
Not Completed 0 0
Arm/Group Title Experimental Active Comparator Placebo Comparator Total
Hide Arm/Group Description Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion Total of all reporting groups
Overall Number of Baseline Participants 1 2 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
2
 100.0%
3
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
Female
1
 100.0%
2
 100.0%
3
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 2 participants 3 participants
1 2 3
1.Primary Outcome
Title Ease of IUD Insertion (Use of Ancillary Measures)
Hide Description The primary outcome is the proportion in each group able to have the IUD inserted in a standard fashion without the ancillary measures of mechanical dilation of the cervix, placement of paracervical nerve block, or using abdominal ultrasound for guidance. The null hypothesis for the primary outcome is that misoprostol does not influence difficulty of insertion.
Time Frame During the IUD insertion procedure, up to 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental Active Comparator Placebo Comparator
Hide Arm/Group Description:
Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
Overall Number of Participants Analyzed 1 2
Measure Type: Number
Unit of Measure: participants
1 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental Active Comparator Placebo Comparator
Hide Arm/Group Description Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
All-Cause Mortality
Experimental Active Comparator Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Experimental Active Comparator Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/2 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Experimental Active Comparator Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/2 (0.00%) 
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Christina Gavito
Organization: University of Colorado Denver
Phone: 303-724-5559
EMail: christina.gavito@ucdenver.edu
Publications:
Ghersi D. Prospective Meta-Analysis Methods Group. The Cochrane Collaboration 2002 [cited July 2, 2008]; Available from: http://www.cochrane.org/docs/pma.htm
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01422226    
Other Study ID Numbers: 10-1060
First Submitted: August 22, 2011
First Posted: August 23, 2011
Results First Submitted: February 11, 2015
Results First Posted: February 26, 2015
Last Update Posted: February 2, 2017