Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
Shanghai Key Laboratory Embryo Original Diseases, Shanghai, China.
BMJ Open. 2021 Aug 30;11(8):e045770. doi: 10.1136/bmjopen-2020-045770.
Recently, the rate of caesarean sections (CS) worldwide has risen and CS-associated complications such as niche have increased substantially. Until now, evidence-based clinical guidelines for the treatment of niche-related symptoms remain absent. In patients with postmenstrual spotting, it has not been studied if the effect of levonorgestrel 52 mg intrauterine system (LNG-IUS 52 mg) is superior to that of hysteroscopy. This study will answer the question of whether LNG-IUS 52 mg is more effective in improving postmenstrual spotting than hysteroscopic niche resection in women with niche-related spotting at 6 months after randomisation.
This is a randomised controlled trial. A total of 208 women with postmenstrual spotting related to niche in the caesarean uterine scar of at least 2 mm and residual myometrium of at least 2.2 mm evaluated by MRI will be included. Women desiring to conceive within 1 year, with contraindications for LNG-IUS 52 mg or hysteroscopic surgery will be excluded. After informed consent is obtained, eligible women will be randomly allocated to LNG-IUS 52 mg or hysteroscopic niche resection at 1:1. The primary outcome is the efficacy in reducing postmenstrual spotting at 6 months after randomisation. The secondary outcomes include menstrual pattern, total days of blood loss per month, rate of amenorrhoea, side effects and complications.We will use a Visual Analogue Scale for chronic pelvic pain, urological symptoms and women's satisfaction (five-point Likert scale).
The study was approved by the local medical ethics committee and by the Institutional Review Board of the International Peace Maternity and Child Health Hospital, Shanghai, China (No. GKLW 2019-08). Participants will sign a written informed consent before participation. The results of this study will be submitted to a peer-reviewed journal for publication.
ChiCTR1900025677.
最近，全球剖宫产率（CS）上升，与 CS 相关的并发症（如 niche）显著增加。到目前为止，尚缺乏 niche 相关症状治疗的循证临床指南。对于经后点状出血的患者，尚未研究左炔诺孕酮 52mg 宫内节育系统（LNG-IUS 52mg）的效果是否优于宫腔镜 niche 切除术。本研究将回答以下问题：在随机分组后 6 个月时，LNG-IUS 52mg 是否比宫腔镜 niche 切除术更能改善与 niche 相关的点状出血。
这是一项随机对照试验。共纳入 208 例经 MRI 评估 CS 子宫瘢痕内 niche 至少 2mm，残留肌层至少 2.2mm，经后点状出血相关的患者。排除 1 年内有妊娠意愿、LNG-IUS 52mg 或宫腔镜手术禁忌证的患者。获得知情同意后，将符合条件的患者以 1:1 比例随机分配至 LNG-IUS 52mg 组或宫腔镜 niche 切除术组。主要结局是随机分组后 6 个月减少经后点状出血的疗效。次要结局包括月经模式、每月总失血量、闭经率、副作用和并发症。我们将使用慢性盆腔痛、泌尿科症状和女性满意度的视觉模拟量表（五分 Likert 量表）。
该研究得到了当地医学伦理委员会和中国上海国际和平妇幼保健院机构审查委员会的批准（编号：GKLW 2019-08）。参与者在参与前将签署书面知情同意书。本研究结果将提交给同行评议期刊发表。
ChiCTR1900025677。
