Use of Misoprostol in Case of Insertion Failure of Intrauterine Contraceptives

Phase 4

Completed

• Conditions: Cervical Stenosis
• Interventions: Drug: Misoprostol

• Registration Number: NCT01754649
• Lead Sponsor: Luis Bahamondes

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.

Study Timeline

• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-20
• Study First Posted: 2012-12-21
• Study Start: 2013-01
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
misoprostol vaginal 200 mcg	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.
placebo	Misoprostol	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Side-effects of misoprostol	12 months	To assess the side-effects of misoprostol versus placebo

Trial Locations

Locations (2)

Family Planning Clinic, University of Campinas; 🇧🇷 Campinas, SP, Brazil

University of Campinas; 🇧🇷 Campinas, SP, Brazil