Use of levonorgestrel-releasing intrauterine system in women using oral anticoagulants

• Grant number: 18/18323-4
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: October 01, 2018
• End date: September 30, 2019
• Field of knowledge: Health Sciences - Medicine - Maternal and Child Health
• Principal Investigator: Luis Guillermo Bahamondes
• Grantee: Eliza Pinheiro Brull
• Host 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

Women taking oral anticoagulants often have abnormal uterine bleeding (AUB). For women who need long-term anticoagulation the levonorgestrel-releasing intrauterine system (IUS-LNG) is an alternative for bleeding control and also for contraception. However, it is unclear whether the menstrual pattern of women using oral anticoagulants and IUS-LNG is similar to that of non-users of anticoagulants. Objective: To evaluate the menstrual pattern and satisfaction of women using oral anticoagulants. In addition, evaluate complications during the insertion of the IUS-LNG, discontinuation rates and their reasons. Materials and Methods: Database study to analyze all the women from the Family Planning Clinic of the Department of Tocogynecology of the University of Campinas, from 2007 to 2017,(around 11,000 women) and identify women taking anticoagulants and who received IUS-LNG (Mirena, Bayer Oy, Turku, Finland). Our clinical routine for these patients is to perform an initial follow-up between 40 to 60 days after placement and after that, every 12 months. The primary conclusion will be to evaluate the menstrual pattern which will be defined according to criteria established by the World Health Organization, over a period of 90 days, in amenorrhea (absence of vaginal bleeding), prolonged bleeding (bleeding or spotting for more than 14 days ), frequent bleeding (vaginal bleeding or spotting for more than 5 days), infrequent bleeding (1 or 2 days of bleeding or spotting), irregular bleeding (3 to 5 days of bleeding or spotting followed by less than 3 bleeding intervals for 14 days) or regular bleeding. The secondary outcome is satisfaction level referred to by the women as satisfied or dissatisfied. The existence of complications at insertion will be categorized as expulsion of the IUS, increased bleeding during insertion and perforation and damage to the reproductive or gastrointestinal system. For data collection, after identification of women and gathering of demographic and IUD insertion data, the menstrual pattern will be appointed at each visit, as well as time to reach the menstrual pattern change, adverse events and discontinuity ratio. Telephone contact will also be made in order to check the current menstrual pattern and data regarding the acceptance of the method. The data will be collected in a chart made specific for the study and later transferred into a Microsoft Excel worksheet. Statistical analysis will be done considering standard deviation and percentages.