Effect of intracervical anesthesia on pain associated with the insertion of the le...
| Grant number: | 12/10085-0 |
| Support type: | Regular Research Grants |
| Duration: | December 01, 2012 - November 30, 2014 |
| Field of knowledge: | Health Sciences - Medicine |
| Principal Investigator: | Maria Valeria Bahamondes Makuch |
| Grantee: | Maria Valeria Bahamondes Makuch |
| Home Institution: | Centro de Pesquisas em Saúde Reprodutiva de Campinas (CEMICAMP). Campinas , SP, Brazil |
| Assoc. researchers: | Arlete Maria dos Santos Fernandes ; Ilza Maria Urbano Monteiro ; Luis Guillermo Bahamondes |
Abstract
The age range of women who seek contraceptive methods has grown, and the current trend is to space the number of pregnancies, or even start their first pregnancy at older ages. The demand for long-term reversible contraceptive methods have increased. Among these methods, there are intrauterine devices (IUDs), both the IUD TCu380A and the LNG-IUS, and subdermal implants. However, its use remains limited by lack of trained gynecologists for IUD insertion and the fear of women to the insertion.Objective: To evaluate the success of placement of IUDs (LNG-IUS and TCu380A IUD), after use of misoprostol or placebo in nulligravida and parous women, in whom there was prior failure of insertion by cervical stenosis and to evaluate the dosage of misoprostol, its route of administration and adverse events after use.Methods: A randomized double blind clinical study, in which we will evaluate nulligravida and parous women that came to the Family Planning Clinic at UNICAMP, requesting the insertion of an IUD and in whom there was a failure of the insertion by cervical stenosis. In these women will be administered two doses of 200¼g of misoprostol or two doses of a placebo, 12 hours apart each one vaginally. They will return the next day to another attempt of insertion. In this second return, will be assessed if the insertion was successful or failed again, and this second attempt will be the end of the study.Data analysis: Data about success or failure in the insertion after the use of misoprostol or placebo will be compared by Ç2 test for independent samples. Data of adverse effects and usefulness of the dose, according to treatment group, will also be evaluated by Ç2 test. Subsequently, it will be performed a multiple logistic regression analysis to assess the possible associated variables (treatment group and sociodemographic variables) with the primary outcome (success or failure of the insertion). The significance level will be determinate by 5% (alpha = 0.05). As the sample size is not estimated at this stage of the project, because it is a pilot study, after analyzing the data will be estimated the statistical power of results. (AU)