Use of Misoprostol in Case of Insertion Failure of Intrauterine Contraceptives

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.

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Key information

Conditions

Cervical Stenosis

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Family Planning Clinic, University of Campinas, Campinas, São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

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

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

Time frame: 12 months

To assess the side-effects of misoprostol versus placebo

Sponsors and collaborators

Lead sponsor

Luis Bahamondes

Other

Registry information

Official study title

Assessment of Use of Misoprostol to Facilitate the Insertion of Intrauterine Contraceptives After Failure of Insertion. A Randomized Double-blind Clinical Trial

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Dec 21, 2012
Registry last updated: Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed