RCT Assessing Pregnancy with Intrauterine Devices for Emergency Contraception

使用宫内节育器紧急避孕评估妊娠情况的随机对照试验

• 批准号: 9116262
• 负责人: David Turok
• 金额: $ 23.84万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-27 至 2021-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9116262
• 关键词: Address; Affect; Area; Child; Clinic; Contraceptive Agents; Contraceptive methods; Copper; Copper Intrauterine Devices; Devices; Effectiveness; Emergency Situation; Family Planning; Foundations; Goals; Hemorrhage; High Risk Woman; Home environment; Hormonal; Institute of Medicine (U.S.); Intrauterine Devices; Levonorgestrel; Low income; Mediating; Mediator of activation protein; Menstruation; Methods; Modeling; Monitor; Mothers; Oral; Outcome; Pain; Population; Pregnancy; Pregnancy Rate; Pregnancy Tests; Public Health; Publications; Randomized; Randomized Controlled Trials; Research; Risk; Safety; Sterilization; Testing; Text; Time; United States; United States Food and Drug Administration; Urine; Woman; abortion; clinical research site; combat; comparative effectiveness; comparative efficacy; design; effectiveness research; emergency contraception; experience; follow-up; high risk; improved; innovation; meetings; novel strategies; preference; prevent; programs; public health relevance; randomized trial; reversible contraceptive; satisfaction; unintended pregnancy

 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

 描述(由申请人提供)：由于美国每年有一半的怀孕是意外发生的，因此非常需要寻求新的方法来解决这一长期存在的公共卫生问题。扩大意外怀孕高风险妇女获得高效避孕方法的努力表明，意外怀孕和堕胎的情况有所减少。申请紧急避孕(EC)的妇女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危状态，正在采取行动降低这一风险。与常用的口服激素方法相比，铜宫内节育器有两个优点：它是EC最有效的方法，它可以持续提供高效率的避孕长达12年。我们最近发表的报告显示，在选择铜质宫内节育器的妇女中，12个月后提交EC的妊娠率明显低于选择口服左炔诺孕酮(LNG)的妇女。然而，选择宫内避孕的女性表现出强烈的偏爱左炔诺孕酮(LNG)IUD，因为它可以减少或消除月经出血和不适。由于LNG20宫内节育器对EC的有效性尚不清楚，我们的多学科计划生育研究小组建议进行一项随机对照试验，以评估LNG IUD作为EC的安全性和有效性。这项研究的主要目的是评估在以低收入妇女为主的人群中单独使用LNG20宫内节育器对EC的创新使用。利用我们自2008年以来一直用于研究EC的IUD的相同临床站点，我们将706名参加EC的妇女随机分配到LNG20IUD或铜质T380 IUD。我们的主要目标是利用非劣势设计评估LNG20IUD与铜T380 IUD在EC中的有效性。我们还将评估使用LNG20IUD或铜T380宫内节育器用于EC的妇女的一年续用率和意外妊娠率，并研究与使用第一年的满意度、疼痛和出血相关的续用率机制。这项建议建立在我们为EC成功评估铜IUD的R21奠定的坚实基础上，并成为我们不断发展的研究计划中的下一项创新，该研究计划在EC的女性在场时提供高效的可逆避孕。证明LNG20宫内节育器用于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的使用，并降低美国持续高企的意外怀孕率。