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Use of Misoprostol in Case of Insertion Failure of Intrauterine Contraceptives

Sponsor
Luis Bahamondes (Other)
Overall Status
Completed
CT.gov ID
NCT01754649
Collaborator
(none)
102
Enrollment
2
Locations
2
Arms
23
Duration (Months)
51
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed 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

Study Type:
Interventional
Actual Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Assessment of Use of Misoprostol to Facilitate the Insertion of Intrauterine Contraceptives After Failure of Insertion. A Randomized Double-blind Clinical Trial
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: misoprostol vaginal 200 mcg

The study group will receive two doses of misoprostol (200mcg each tablet) vaginal 12 and 4 hours prior insertion 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.

Drug: Misoprostol
The study group will receive two doses of misoprostol (200mcg each tablet) vaginal 12 and 4 hours prior insertion. 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.
Other Names:
  • PROSTOKOS

    		•
    Placebo Comparator: placebo

    The placebo group will receive two doses of placebo vaginal 12 and 4 hours prior insertion. 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.

    Drug: Misoprostol
    The study group will receive two doses of misoprostol (200mcg each tablet) vaginal 12 and 4 hours prior insertion. 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.
    Other Names:
  • PROSTOKOS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. ease of insertion of intrauterine contraceptives [12 months]

      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.

    Secondary Outcome Measures

    1. Side-effects of misoprostol [12 months]

      To assess the side-effects of misoprostol versus placebo

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Women aged > 18 and <50 years old; Requesting insertion of and IUD or an LNG-IUS Failure of IUD insertion

    Exclusion Criteria:

    Refuse to participate Lost to follow-up at the return visit

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Family Planning Clinic, University of Campinas Campinas SP Brazil 13084-971
    2 University of Campinas Campinas SP Brazil

    Sponsors and Collaborators

    • Luis Bahamondes

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Luis Bahamondes, PI, University of Campinas, Brazil
    ClinicalTrials.gov Identifier:
    NCT01754649
    Other Study ID Numbers:
    • Unicamp/2012/LB
    First Posted:
    Dec 21, 2012
    Last Update Posted:
    Jun 4, 2015
    Last Verified:
    Jun 1, 2015
    Keywords provided by Luis Bahamondes, PI, University of Campinas, Brazil
    intrauterine device
    insertion failure
    Additional relevant MeSH terms:
    Misoprostol

    Study Results

    No Results Posted as of Jun 4, 2015