Introduction This trial reports on use of the copper intrauterine device (IUD) after immediate compared with delayed insertion following medical abortion at 17–20 gestational weeks (GW). Methods This randomised controlled trial was conducted at one tertiary hospital and five community healthcare centres in Cape Town, South Africa. Eligible consenting women were randomised to immediate (within 24 hours) or delayed (3 weeks post-abortion) insertion of the copper IUD. Follow-up was at 6 weeks, 3 months and 6 months. Main outcomes were use of the original IUD and use of any IUD, including replacement IUDs at 6 weeks post-abortion. Secondary outcomes included rates of expulsion and malposition at 6 weeks, use of any IUD at 3 and 6 months, and acceptability of the IUD. Results We recruited and randomised 114 women admitted for elective medical abortion between August 2018 and June 2019. In the immediate and delayed study arms, respectively, 45/55 (82%) and 12/57 (21%) women received the IUD as planned. By intention-to-treat, 56% in the immediate and 19% in the delayed arms were using the original IUD at 6 weeks (p<0.001), and 76% in the immediate and 40% in the delayed arms were using any IUD (p<0.001). Complete expulsion or removal occurred in 32% in the immediate and 7% in the delayed arms (p=0.044). Conclusions Insertion of an IUD immediately after medical abortion at 17–20 GW results in increased use after 6 weeks compared with delayed insertion, however expulsion rates are higher than with interval insertion. Clinical trials registration [NCT03505047][1]), Pan African Trials Registry (www.pactr.org), 201804003324963 [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03505047&atom=%2Ffamilyplanning%2Fearly%2F2021%2F02%2F11%2Fbmjsrh-2020-200932.atom

中文翻译：

---

妊娠 17-20 周药物流产后立即与延迟置入铜宫内节育器：一项随机对照试验

引言 本试验报告了在 17-20 孕周 (GW) 药物流产后立即使用铜宫内节育器 (IUD) 与延迟插入后使用铜宫内节育器 (IUD) 的比较。方法 这项随机对照试验在南非开普敦的一家三级医院和五个社区医疗中心进行。符合条件的同意妇女被随机分配到立即（24 小时内）或延迟（流产后 3 周）插入铜宫内节育器。随访时间分别为 6 周、3 个月和 6 个月。主要结果是使用原始宫内节育器和使用任何宫内节育器，包括流产后 6 周时更换宫内节育器。次要结果包括 6 周时的排出和错位率、3 个月和 6 个月时使用任何 IUD 以及 IUD 的可接受性。结果 我们在 2018 年 8 月至 2019 年 6 月期间招募并随机分配了 114 名因选择性药物流产而入院的女性。在立即和延迟研究组中，分别有 45/55 (82%) 和 12/57 (21%) 的女性按计划接受了 IUD . 通过意向治疗，56% 的即期治疗组和 19% 的延迟治疗组在 6 周时使用了原始 IUD（p<0.001），76% 的即期治疗组和 40% 的延迟治疗组使用任何 IUD (p<0.001)。32% 的即时治疗组和 7% 的延迟治疗组完全排出或移除（p=0.044）。结论 与延迟置入相比，药物流产后立即置入 17-20 GW IUD 导致 6 周后使用量增加，但排出率高于间隔置入。临床试验注册 [NCT03505047][1])，泛非试验注册 (www.pactr.org)，