Women's Health Research Unit, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa
Women's Health Research Unit, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.
BMJ Sex Reprod Health. 2022 Jan;48(1):28-34. doi: 10.1136/bmjsrh-2020-200932. Epub 2021 Feb 12.
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).
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.
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).
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.
NCT03505047), Pan African Trials Registry (www.pactr.org), 201804003324963.
本试验报告了在妊娠 17-20 周（GW）行药物流产后即刻与延迟放置（流产后 3 周）行铜宫内节育器（IUD）的使用情况。
这项随机对照试验在南非开普敦的一家三级医院和五家社区医疗中心进行。符合条件的同意参与者被随机分为即刻（流产后 24 小时内）或延迟（流产后 3 周）放置铜 IUD。随访时间为 6 周、3 个月和 6 个月。主要结局是原始 IUD 的使用和任何 IUD 的使用，包括流产后 6 周时的替换 IUD。次要结局包括 6 周时的脱落和位置不良率、3 个月和 6 个月时任何 IUD 的使用情况以及 IUD 的可接受性。
我们于 2018 年 8 月至 2019 年 6 月期间招募并随机分配了 114 名因择期药物流产而住院的女性。即刻和延迟研究组分别有 45/55（82%）和 12/57（21%）的女性按计划放置了 IUD。根据意向治疗分析，即刻组的 56%和延迟组的 19%在 6 周时使用了原始 IUD（p<0.001），即刻组的 76%和延迟组的 40%在 6 周时使用了任何 IUD（p<0.001）。即刻组完全脱落或取出的发生率为 32%，延迟组为 7%（p=0.044）。
在妊娠 17-20 GW 行药物流产后即刻放置 IUD，与延迟放置相比，6 周后使用增加，但脱落率高于间隔放置。
NCT03505047），泛非试验注册处（www.pactr.org），201804003324963。
