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Use of levonorgestrel-releasing IUD in women submitted to solid organ transplantation

Grant number: 17/08595-4
Support type:Scholarships in Brazil - Scientific Initiation
Effective date (Start): June 01, 2017
Effective date (End): May 31, 2018
Field of knowledge:Health Sciences - Medicine
Principal Investigator:Luis Guillermo Bahamondes
Grantee:Paulo Stahlschmidt
Home Institution: Centro de Atenção Integral à Saúde da Mulher (CAISM). Hospital da Mulher Professor Doutor José Aristodemo Pinotti. Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil
Associated research grant:15/20504-9 - Clinical findings among progestin-only contraceptives' users, AP.TEM

Abstract

There is a lack of data in the literature concerning contraception with intrauterine devices (IUDs) for women with a history of solid organ transplant. Regular menstrual cycles are restored in half of women with a history of solid organ transplant. Consequently, these women may become pregnant. Women that undergo immunosuppression after transplantation have a high-risk pregnancy. Such condition can result in both worsening maternal status and risk to the fetus. Additionally, there is no consensus on the best immunosuppression regimen or transplant rejection treatment during pregnancy. Therefore, long-acting reversible contraceptives, such as the IUD, are certainly adequate for this population. Nevertheless, no consensus on the safety and effectiveness of IUD use in female transplant recipients is found in the literature. Women with uncomplicated solid organ transplantation meet the eligibility criteria for LNG-IUS, as proposed by the Center for Disease Control (CDC). However, the American Society of Transplantation does not recommend the use of IUD in women under immunosuppression therapy due to the increased risk for infection and potential decreased effectiveness of the contraception. Taking into account this discrepancy and the lack of articles, we propose this study, which intends to evaluate transplanted women using LNG-IUS. Objectives: Evaluate acceptability and side effects of LNG-IUS use in transplanted women. Evaluate the history of pelvic inflammatory disease during IUD use. As secondary objective, evaluate menstrual pattern, duration of use and causes of discontinuation or level of satisfaction with the method. Materials and Methods: Cross-sectional study, evaluating all women with history of transplant and LNG-IUS use. Inclusion criteria: history of solid organ transplant, immunosuppression therapy and use of LNG-IUS. Exclusion criteria: women unreachable by phone. The study participants will be selected from a data bank of LNG-IUS users. This data bank is from the Family Planning Service of UNICAMP and is consisted of around 10 000 women. After patient identification and collection of data concerning demographics, IUD insertion, adverse events and causes of discontinuation, telephone contact will be conducted. In such contact, will be audited the immunosuppressive drugs used and level of satisfaction with the method. All data will be placed in a form designed for the study, and later entered in a Microsoft Excel sheet. Statistical analysis will be executed through mean and standard deviation, and percentages. (AU)