Use of Misoprostol in Case of Insertion Failure of Intrauterine Contraceptives

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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Stenosis
• Intervention / Treatment: Drug: Misoprostol

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
• Enrollment (Actual): 102
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Campinas, SP, Brazil, 13084-971
      • Family Planning Clinic, University of Campinas
    • Campinas, SP, Brazil
      • University of Campinas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ease of insertion of intrauterine contraceptives	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side-effects of misoprostol	To assess the side-effects of misoprostol versus placebo	12 months

Collaborators and Investigators

• Sponsor: Luis Bahamondes

Publications and helpful links

General Publications

• Bahamondes MV, Espejo-Arce X, Bahamondes L. Effect of vaginal administration of misoprostol before intrauterine contraceptive insertion following previous insertion failure: a double blind RCT. Hum Reprod. 2015 Aug;30(8):1861-6. doi: 10.1093/humrep/dev137. Epub 2015 Jun 3.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 18, 2012
• First Submitted That Met QC Criteria: December 20, 2012
• First Posted (Estimate): December 21, 2012

Study Record Updates

• Last Update Posted (Estimate): June 4, 2015
• Last Update Submitted That Met QC Criteria: June 3, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: intrauterine device; insertion failure
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: Unicamp/2012/LB