Comparing levonorgestrel intrauterine system with hysteroscopic niche resection in women with postmenstrual spotting related to a niche in the uterine cesarean scar: a randomized, open-label, controlled trial

作者：Jian Zhang, Chenfeng Zhu, Li Yan, Yang Wang, Qian Zhu, Chuqing He, Xiaoqing He, Sifan Ji, Yuan Tian, Li Xie, Yan Liang, Wei Xia, Ben W. Mol, Judith A.F. Huirne · 发表于：American Journal of Obstetrics and Gynecology · 年份：2023 · DOI：10.1016/j.ajog.2023.03.020 · 被引用次数：20 · 研究领域：Maternal and Perinatal Health Interventions、Gynecological conditions and treatments、Maternal and fetal healthcare

BACKGROUND: Postmenstrual spotting and chronic pelvic pain after cesarean delivery are associated with the presence of niches. Levonorgestrel intrauterine system (52 mg) and hysteroscopic niche resection have been shown to relieve niche-related symptoms at 6 months after the intervention. OBJECTIVE: This trial aimed to compare the effectiveness of 52-mg levonorgestrel intrauterine system with that of hysteroscopic niche resection in reducing niche-related postmenstrual spotting. STUDY DESIGN: This randomized, open-label, controlled trial was conducted at a medical center in Shanghai, China. Women with symptoms of postmenstrual spotting after cesarean delivery, with a niche depth of at least 2 mm and residual myometrium of at least 2.2 mm on magnetic resonance imaging, and no intention to conceive within the next year were randomly assigned to receive treatment with 52-mg levonorgestrel intrauterine system or hysteroscopic niche resection. The primary outcome was the reduction in postmenstrual spotting at 6 months after randomization, defined as the percentage of women with a reduction of at least 50% in spotting days relative to baseline. Efficacy and safety were assessed using intention-to-treat analysis. RESULTS: =.001), with a stronger reduction observed in the levonorgestrel intrauterine system group (P=.001). There was also a significant interaction between time and treatment (P=.007). From 9 months onward, a more significant reduction in spotting was observed in the lev...