RCT Assessing Pregnancy with Intrauterine Devices for Emergency Contraception

 描述（由申请人提供）：由于美国每年有一半的怀孕是意外的，因此非常需要寻求新的方法来解决这一持续存在的公共卫生问题。通过努力使意外怀孕风险高的妇女更多地获得高效避孕方法，意外怀孕和堕胎的情况有所减少。接受紧急避孕（EC）的女性是启动高效可逆避孕的理想人群，因为她们处于意外怀孕的高风险中，并正在采取措施降低这种风险。 铜宫内节育器与常用的口服激素避孕法相比有两个优点：它是最有效的避孕法，可持续提供高效避孕长达12年。我们最近的出版物表明，与选择口服左炔诺孕酮（LNG）的妇女相比，选择铜IUD的妇女在接受EC治疗后12个月的妊娠率显著降低。然而，选择宫内避孕的妇女对左炔诺孕酮（LNG）IUD表现出强烈的偏好，因为它可以减少或消除月经出血和不适。由于LNG 20宫内节育器对EC的有效性仍然未知，我们的多学科计划生育研究小组提出了一项随机对照试验，以评估LNG宫内节育器作为EC的安全性和有效性。本研究的主要目标是评估在以低收入妇女为主的人群中单独使用LNG20宫内节育器治疗EC的创新性使用。 自2008年以来，我们一直使用相同的临床研究中心研究子宫内膜异位症的宫内节育器，我们将706名女性随机分配到LNG 20宫内节育器或铜T380宫内节育器。我们的主要目的是利用非劣效性设计评估LNG 20 IUD与铜T380 IUD治疗EC的有效性。我们还将评估开始使用LNG20 IUD或铜T380 IUD治疗EC的妇女的一年持续率和意外妊娠率，并研究与使用第一年的满意度，疼痛和出血相关的持续机制。 该提案建立在我们成功的R21评估用于EC的铜IUD所奠定的坚实基础之上，并作为我们不断增长的研究计划的下一个创新，在女性出现EC时提供高效的可逆避孕。证明LNG 20 IUD用于EC的有效性、安全性和可接受性将改善寻求EC的妇女的选择，并有可能消除IUD启动的重大障碍，增加IUD使用，并降低美国持续高的意外怀孕率。

 DESCRIPTION (provided by applicant): With half of U.S. pregnancies each year being unintended there is a great need to seek novel approaches to address this persistent public health issue. Efforts that expand access to highly effective methods of contraception to women at high risk of unintended pregnancy have demonstrated reductions in unintended pregnancies and abortions. Women presenting for emergency contraception (EC) comprise an ideal population in which to initiate highly effective reversible contraception, as they are at a high rik of unintended pregnancy and are acting to reduce that risk. The copper IUD possesses two advantages over the common oral hormonal methods of EC: it is the most effective method of EC and it continues to provide highly effective contraception for up to 12 years. Our recent publication demonstrated a significantly lower pregnancy rate 12 months after presenting for EC among women who selected the copper IUD versus those who selected oral levonorgestrel (LNG). However, women selecting intrauterine contraception have shown a strong preference for the levonorgestrel (LNG) IUD because it reduces or eliminates menstrual bleeding and discomfort. As the LNG20 IUDs effectiveness for EC remains unknown our multi-disciplinary Family Planning Research Group proposes a randomized controlled trial to assess the safety and efficacy of the LNG IUD as EC. The main goal of this research is to evaluate the innovative use of the LNG20 IUD alone for EC in a population of predominantly low-income women. Utilizing the same clinical sites we have consistently employed to study the IUD for EC since 2008 we will randomly assign 706 women presenting for EC to either the LNG20 IUD or the copper T380 IUD. Our primary aim is to assess the efficacy of the LNG20 IUD vs. the copper T380 IUD for EC utilizing a non- inferiority design. We will also assess one-year continuation and unintended pregnancy rates in women initiating the LNG20 IUD or copper T380 IUD for EC and study the mechanisms of continuation related to satisfaction, pain, and bleeding over the first year of use. This proposal builds on the strong foundation laid by our successful R21 assessing the copper IUD for EC and serves as the next innovation in our growing research program offering highly effective reversible contraception at the time women present for EC. Demonstrating the efficacy, safety, and acceptability of the LNG20 IUD for EC will improve options for women seeking EC and has the potential to eliminate a significant barrier to IUD initiation, increase IUD use, and lower the persistently high rate of unintended pregnancy in the U.S. 1