Use of Misoprostol in Case of Insertion Failure of Intrauterine Contraceptives

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Campinas, Brazil
Sponsor:
Information provided by (Responsible Party):
Luis Bahamondes, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01754649
First received: December 18, 2012
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Cervical Stenosis
Drug: Misoprostol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • ease of insertion of intrauterine contraceptives [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Side-effects of misoprostol [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To assess the side-effects of misoprostol versus placebo


Estimated Enrollment: 102
Study Start Date: January 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754649

Locations
Brazil
Family Planning Clinic, University of Campinas Not yet recruiting
Campinas, SP, Brazil, 13084-971
Contact: Luis Bahamondes, MD; PhD    55-19-3289-2856 ext 209    bahamond@caism.unicamp.br   
Contact: Adriana Barros    55-19-3289-2856 ext 209    abarros@cemicamp.org.br   
Principal Investigator: Luis Bahamondes, MD; PhD         
Sub-Investigator: Maria Valeria Bahamondes, MD;PhD         
University of Campinas Recruiting
Campinas, SP, Brazil
Contact: Luis Bahamondes, PhD    55 19 32892856 ext 209    bahamond@caism.unicamp.br   
Sponsors and Collaborators
Luis Bahamondes
  More Information

No publications provided

Responsible Party: Luis Bahamondes, PI, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01754649     History of Changes
Other Study ID Numbers: Unicamp/2012/LB
Study First Received: December 18, 2012
Last Updated: May 29, 2014
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 27, 2014