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Use of Misoprostol in Case of Insertion Failure of Intrauterine Contraceptives

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ClinicalTrials.gov Identifier: NCT01754649
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
Luis Bahamondes, University of Campinas, Brazil

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
Cervical Stenosis Drug: Misoprostol 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 Type : Interventional  (Clinical Trial)
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 : January 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol
U.S. FDA Resources

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 Name: 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 Name: PROSTOKOS



Primary Outcome Measures :
  1. ease of insertion of intrauterine contraceptives [ Time Frame: 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 [ Time Frame: 12 months ]
    To assess the side-effects of misoprostol versus placebo



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

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754649


Locations
Brazil
Family Planning Clinic, University of Campinas
Campinas, SP, Brazil, 13084-971
University of Campinas
Campinas, SP, Brazil
Sponsors and Collaborators
Luis Bahamondes

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luis Bahamondes, PI, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01754649     History of Changes
Other Study ID Numbers: Unicamp/2012/LB
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015

Keywords provided by Luis Bahamondes, University of Campinas, Brazil:
intrauterine device
insertion failure

Additional relevant MeSH terms:
Contraceptive Agents
Misoprostol
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics