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超声引导下手动吸引与电动吸引治疗宫腔粘连的随机对照试验。

Intrauterine adhesion in ultrasound-guided manual vacuum aspiration (USG-MVA) versus electric vacuum aspiration (EVA): a randomised controlled trial.

机构信息

Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Territories, Hong Kong SAR, China.

出版信息

BMC Pregnancy Childbirth. 2024 Feb 14;24(1):135. doi: 10.1186/s12884-024-06328-y.

DOI:10.1186/s12884-024-06328-y
PMID:38355420
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10865674/
Abstract

BACKGROUND

Intrauterine adhesion (IUA) can arise as a potential complication following uterine surgery, as the surgical procedure may damage the endometrial stratum basalis. The objective of this study was to assess and compare the occurrence of IUA in women who underwent ultrasound-guided manual vacuum aspiration (USG-MVA) versus electric vacuum aspiration (EVA) for managing first-trimester miscarriage.

METHODS

This was a prospective, single-centre, randomised controlled trial conducted at a university-affiliated tertiary hospital. Chinese women aged 18 years and above who had a delayed or incomplete miscarriage of ≤ 12 weeks of gestation were recruited in the Department of Obstetrics and Gynaecology at the Prince of Wales. Recruited participants received either USG-MVA or EVA for the management of their miscarriage and were invited for a hysteroscopic assessment to evaluate the incidence of IUA between 6 and 20 weeks after the surgery. Patients were contacted by phone at 6 months to assess their menstrual and reproductive outcomes.

RESULTS

303 patients underwent USG-MVA or EVA, of whom 152 were randomised to 'USG-MVA' and 151 patients to the 'EVA' group. Out of the USG-MVA group, 126 patients returned and completed the hysteroscopic assessment, while in the EVA group, 125 patients did the same. The incidence of intrauterine adhesion (IUA) was 19.0% (24/126) in the USG-MVA group and 32.0% (40/125) in the EVA group, showing a significant difference (p < 0.02) between the two groups. No significant difference in the menstrual outcomes at 6 months postoperatively between the two groups but more patients had miscarriages in the EVA group with IUA.

CONCLUSIONS

IUAs are a possible complication of USG-MVA. However, USG-MVA is associated with a lower incidence of IUA postoperatively at 6-20 weeks. USG-MVA is a feasible, effective, and safe alternative surgical treatment with less IUA for the management of first-trimester miscarriage.

TRIAL REGISTRATION

The study was registered with the Centre for Clinical Research and Biostatics- Clinical Trials Registry (CCRBCTR), which is a partner registry of the WHO Primary Registry-Chinese Clinical Trials Registry (ChiCTR) (Unique Trial Number: ChiCTR1900023198 with the first trial registration date on 16/05/2019).

摘要

背景

宫内粘连(IUA)可能是子宫手术后的一种潜在并发症,因为手术可能会损伤子宫内膜基底层。本研究的目的是评估和比较超声引导手动吸引(USG-MVA)与电动吸引(EVA)在管理早期妊娠流产中的 IUA 发生率。

方法

这是一项在大学附属三级医院进行的前瞻性、单中心、随机对照试验。在威尔斯亲王医院妇产科招募年龄在 18 岁及以上、妊娠 12 周内延迟或不完全流产的中国妇女。招募的参与者接受 USG-MVA 或 EVA 治疗流产,并邀请他们在手术后 6 至 20 周进行宫腔镜评估,以评估 IUA 的发生率。在术后 6 个月通过电话联系患者,评估其月经和生殖结局。

结果

303 名患者接受了 USG-MVA 或 EVA 治疗,其中 152 名患者随机分配至“USG-MVA”组,151 名患者分配至“EVA”组。USG-MVA 组中有 126 名患者返回并完成了宫腔镜评估,EVA 组中有 125 名患者完成了同样的评估。USG-MVA 组的宫腔粘连(IUA)发生率为 19.0%(24/126),EVA 组为 32.0%(40/125),两组之间存在显著差异(p<0.02)。两组术后 6 个月的月经结局无显著差异,但 EVA 组有 IUA 的患者流产率更高。

结论

IUA 是 USG-MVA 的一种可能并发症。然而,USG-MVA 术后 6-20 周发生 IUA 的发生率较低。USG-MVA 是一种可行、有效、安全的替代手术治疗方法,对于管理早期妊娠流产,其发生 IUA 的风险较低。

试验注册

该研究在临床研究与生物统计学中心-临床试验注册中心(CCRBCTR)注册,该中心是世界卫生组织初级注册处-中国临床试验注册中心(ChiCTR)的合作伙伴注册处(独特的试验编号:ChiCTR1900023198,首次试验注册日期为 2019 年 5 月 16 日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/061a/10865674/1d00a12a462d/12884_2024_6328_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/061a/10865674/1d00a12a462d/12884_2024_6328_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/061a/10865674/1d00a12a462d/12884_2024_6328_Fig1_HTML.jpg

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