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Clinical Trial Summary

To assess the usefulnes sof misoprostol versus placebo (in a double-blind placebo controlled randomized clinical trial)to facilitate the insertion of copper-IUD and the levonorgestrel-releasing intrauterine system (LNG-IUS) in cases of failure due to cervical stenosis in either nulligravidas and parous women. Additionally to evaluate the side-effects of the misoprostol. The hypothesis is that misoprostol may be better than placebo.


Clinical Trial Description

Women attended at the Family Planning clinic of the University of Campinas who requested the insertion of a copper-IUD or an LNG-IUS and who failed in the attempt due to cervical stenosis will be randomized in two groups (1:1). The study group will receive two doses of misoprostol (200mcg each tablet) vaginal 12 and 4 hours prior insertion and the control group will receive placebo in the same schedule. The sample will be 50 women in each group. After 24 hours of the insertion failure the women will return to the clinic and a new attempt of insertion will be done. At this time we will evaluate if the insertion was able to do or not. The data will be analyzing with χ2 test for independent samples. After that a multiple logistic analysis will be perform to evaluate the associated variables with the result (failure or successful) insertion. The level of significance will be established at P<.005. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01754649
Study type Interventional
Source University of Campinas, Brazil
Contact
Status Completed
Phase Phase 4
Start date January 2013
Completion date December 2014

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