Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, the Departments of Obstetrics and Gynecology, University of California, Los Angeles, University of California, Davis, University of California, San Diego, and University of California, Irvine, and the University of California Fibroid Network, California; Tassone Advanced ObGyn, Round Rock, Texas; the Gynecological Institute of Chicago, Chicago, Illinois; and the Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas.
Obstet Gynecol. 2024 May 1;143(5):612-618. doi: 10.1097/AOG.0000000000005548. Epub 2024 Mar 1.
To compare pregnancy outcomes after laparoscopic radiofrequency ablation and myomectomy.
The ULTRA (Uterine Leiomyoma Treatment With Radiofrequency Ablation) study is an ongoing multicenter prospective cohort study with longitudinal follow-up up to 5 years comparing outcomes of radiofrequency ablation with myomectomy in premenopausal women older than age 21 years with symptomatic uterine leiomyomas. Participants were queried every 6 months after surgery to assess the incidence of pregnancy and pregnancy outcomes.
Among 539 women enrolled in ULTRA, a total of 37 participants (mean age at first pregnancy 35.0±4.7 years) conceived 43 times as of March 2023 (22 radiofrequency ablation, 21 myomectomy). The average length of follow-up time after all procedures was 2.5±1.0 years. The baseline miscarriage rate in the study population was 33.3%. In participants who underwent radiofrequency ablation, 9 of 22 pregnancies (40.9%, 95% CI, 20.3-61.5%) ended in first-trimester miscarriage, 11 resulted in live births (50.0%, 95% CI, 29.1-70.9%), one resulted fetal death at 30 weeks of gestation, and one resulted in uterine rupture during miscarriage treatment with misoprostol 10 weeks after radiofrequency ablation. Among the live births in the radiofrequency ablation group, 45.5% were by vaginal delivery. In the myomectomy group, 9 of 21 pregnancies (42.9%, 95% CI, 21.7-64.0%) ended in first-trimester miscarriage and 12 resulted in live births (57.1%, 95% CI, 36.0-78.3%). There were no significant differences in the likelihood of live birth or miscarriage between the study groups.
Full-term pregnancy and vaginal delivery are achievable after radiofrequency ablation of leiomyomas. However, in this interim analysis, the miscarriage rate in both radiofrequency ablation and myomectomy groups was higher than expected for women in this age group. Long-term data collection in the ongoing ULTRA study aims to further understand pregnancy outcomes after radiofrequency ablation compared with myomectomy.
ClinicalTrials.gov , NCT0210094.
比较腹腔镜射频消融与子宫肌瘤剔除术后的妊娠结局。
ULTRA（子宫肌瘤射频消融治疗）研究是一项正在进行的多中心前瞻性队列研究，对 21 岁以上有症状的子宫肌瘤的绝经前妇女进行射频消融与子宫肌瘤剔除术的长期随访，最长随访时间 5 年。术后每 6 个月对患者进行妊娠和妊娠结局评估。
截至 2023 年 3 月，在 ULTRA 中纳入的 539 名女性中，共有 37 名参与者（首次妊娠的平均年龄为 35.0±4.7 岁）妊娠 43 次（22 例射频消融，21 例子宫肌瘤剔除术）。所有手术后的平均随访时间为 2.5±1.0 年。研究人群的基线流产率为 33.3%。在接受射频消融的参与者中，22 次妊娠中有 9 次（40.9%，95%CI，20.3-61.5%）在妊娠早期流产，11 次活产（50.0%，95%CI，29.1-70.9%），1 次在妊娠 30 周时胎儿死亡，1 次在射频消融后 10 周用米索前列醇治疗流产时发生子宫破裂。在射频消融组的活产中，45.5%为阴道分娩。在子宫肌瘤剔除组中，21 次妊娠中有 9 次（42.9%，95%CI，21.7-64.0%）在妊娠早期流产，12 次活产（57.1%，95%CI，36.0-78.3%）。两组间活产或流产的可能性无显著差异。
子宫肌瘤射频消融后可实现足月妊娠和阴道分娩。然而，在这项中期分析中，射频消融和子宫肌瘤剔除术组的流产率均高于该年龄段女性的预期。正在进行的 ULTRA 研究的长期数据收集旨在进一步了解射频消融与子宫肌瘤剔除术相比后的妊娠结局。
ClinicalTrials.gov，NCT0210094。
