Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden; Center for Clinical Research Dalarna, Uppsala University, Falun, Sweden.
Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden; Department of Obstetrics and Gynecology, Danderyd Hospital, Stockholm, Sweden.
Am J Obstet Gynecol. 2023 Jan;228(1):53.e1-53.e9. doi: 10.1016/j.ajog.2022.07.063. Epub 2022 Aug 13.
Intrauterine devices are safe, well-tolerated, and known to reduce the risk of unwanted pregnancies. At medical abortion, intrauterine devices are placed at a follow-up visit. Patients who miss this visit risk being left without contraception.
This study aimed to investigate if placement of an intrauterine device within 48 hours of completed medical abortion at up to 63 days' gestation leads to higher user rates at 6 months after the abortion compared with placement at 2 to 4 weeks after abortion. Furthermore, we aimed to compare continued use of intrauterine devices, safety, and patient satisfaction between groups.
We performed an open-label, randomized, controlled, multicenter, superiority trial (phase 3). A total of 240 patients requesting medical abortion at up to 63 days' gestation and opting for an intrauterine device were allocated to placement within 48 hours of complete medical abortion (intervention group) or at 2 to 4 weeks after abortion (control group). We defined the abortion as complete after bleeding with clots and cessation of heavy bleeding following the use of misoprostol. Patients answered questionnaires at 3, 6, and 12 months. The primary outcome was use of intrauterine device at 6 months postabortion. Secondary outcomes included expulsion rate, pain at placement, adverse events and complications from the abortion, acceptability, and pregnancies and their outcomes. Differences in nonparametric continuous variables were analyzed with the Mann-Whitney U test and differences in dichotomous variables with the chi square or Fisher exact tests. A P value of <.05 was considered statistically significant.
In the intervention group, 91 of 111 (82%) participants used an intrauterine device at 6 months after the abortion vs 87 of 112 (77.7%) in the control group, with a difference in proportion of 4.3% (95% confidence interval, -0.062 to 0.148; P=.51). Attendance rate and rate of successful intrauterine device placement were similar between the groups. Patients in the intervention group had lower pain scores at placement of the intrauterine device (mean pain score [visual analogue scale], 32.3; standard deviation, 29) compared with the control group (mean pain score [visual analogue scale], 43.4; standard deviation, 27.9; P=.002). Patients preferred their allocated time of placement significantly more often in the intervention group (83/111, 74.8%) than in the control group (70/114, 61.4%; P=.03). Use of ultrasound at intrauterine device placement (because of doubts concerning complete abortion) was more common in the intervention group (43/108, 39.8%) than in the control group (15/101, 14.9%; P<.001), and in one patient in the control group a retained gestational sac was found. Three patients in the intervention group and 2 in the control group had a vacuum aspiration. No difference was found in intrauterine device expulsion rates between the groups. Expulsion during the first 6 months after abortion was experienced by 9 of 97 (9.3%) patients in the intervention group and 4 of 89 (4.5%; P=.25) in the control group. There were no perforations or infections requiring antibiotic treatment.
Placement of an intrauterine device within 48 hours after medical abortion at ≤63 days' gestation does not lead to higher user rates at 6 months after the abortion compared with intrauterine device placement at 2 to 4 weeks after abortion. When compared with placement at a follow-up visit after 2 to 4 weeks, intrauterine device placement within 48 hours after early medical abortion seems safe, is preferred by patients, and is associated with lower pain scores.
宫内节育器安全、耐受良好，并且已知可降低意外怀孕的风险。在药物流产时，会在随访时放置宫内节育器。错过这次就诊的患者可能会面临没有避孕措施的风险。
本研究旨在探讨在妊娠 63 天内药物流产后 48 小时内放置宫内节育器与流产后 2 至 4 周放置宫内节育器相比，是否会导致流产后 6 个月的使用率更高。此外，我们旨在比较两组之间宫内节育器的持续使用、安全性和患者满意度。
我们进行了一项开放标签、随机、对照、多中心、优效性试验（第 3 阶段）。共有 240 名要求在妊娠 63 天内进行药物流产并选择宫内节育器的患者被分配在药物流产完全后 48 小时内（干预组）或流产后 2 至 4 周内（对照组）放置宫内节育器。我们定义在使用米索前列醇后出血伴有血块且大量出血停止后，流产完全。患者在 3、6 和 12 个月时回答问卷。主要结局是流产后 6 个月时宫内节育器的使用情况。次要结局包括排出率、放置时疼痛、流产相关的不良事件和并发症、可接受性以及妊娠及其结局。非参数连续变量的差异采用 Mann-Whitney U 检验分析，二分类变量的差异采用卡方检验或 Fisher 确切检验分析。P 值<.05 被认为具有统计学意义。
在干预组中，111 名参与者中有 91 名（82%）在流产后 6 个月时使用了宫内节育器，而在对照组中，112 名参与者中有 87 名（77.7%），比例差异为 4.3%（95%置信区间，-0.062 至 0.148；P=.51）。两组的就诊率和宫内节育器放置成功率相似。与对照组相比（视觉模拟评分，43.4；标准差，27.9），干预组的患者在放置宫内节育器时疼痛评分较低（平均疼痛评分[视觉模拟评分]，32.3；标准差，29）（P=.002）。与对照组相比（61.4%；P=.03），干预组的患者更经常选择他们所分配的放置时间。在干预组（43/108，39.8%）中，比对照组（15/101，14.9%）更常见在放置宫内节育器时使用超声（因为怀疑流产不完全）（P<.001），并且在对照组中有 1 名患者发现有妊娠囊残留。干预组中有 3 名患者和对照组中有 2 名患者需要进行真空抽吸。两组的宫内节育器排出率无差异。在流产后的前 6 个月内，干预组有 9 名（9.3%）患者和对照组有 4 名（4.5%）患者经历了排出（P=.25）。没有穿孔或需要抗生素治疗的感染。
在妊娠 63 天内药物流产后≤63 天内，在流产后 48 小时内放置宫内节育器与流产后 2 至 4 周后放置宫内节育器相比，并不会导致流产后 6 个月时的使用率更高。与 2 至 4 周后随访时放置相比，在妊娠 63 天内药物流产后 48 小时内放置宫内节育器似乎是安全的，更受患者青睐，且与较低的疼痛评分相关。
