Assessment of Use of Misoprostol to Facilitate the Insertion of Intrauterine Contraceptives After Failure of Insertion. A Randomized Double-blind Clinical Trial
Overview
- Phase
- Phase 4
- Intervention
- Misoprostol
- Conditions
- Cervical Stenosis
- Sponsor
- Luis Bahamondes
- Enrollment
- 102
- Locations
- 2
- Primary Endpoint
- ease of insertion of intrauterine contraceptives
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
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.
Investigators
Luis Bahamondes
PI
University of Campinas, Brazil
Eligibility 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
Arms & Interventions
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.
Intervention: Misoprostol
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.
Intervention: Misoprostol
Outcomes
Primary Outcomes
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 Outcomes
- Side-effects of misoprostol(12 months)