终版全文|宫颈机能不全诊治中国专家共识(2025版)

专家共识 妇产科 · 2025 · 中华围产医学杂志

一、CI的定义和诊断

推荐意见1-1:在孕期保健过程中应注意针对有CI高危因素的孕妇进行宫颈机能的筛查,孕期宫颈机能筛查手段主要是经阴道超声监测宫颈长度和宫颈形态。(证据等级:Ⅲ,推荐强度:C) 推荐意见1-2:CI主要是依据妊娠中期无痛性宫颈扩张的典型临床表现,结合超声或阴道检查进行诊断,并综合患者临床资料排除感染或其他因素导致的宫颈改变和/或晚期流产或早产。(证据等级:Ⅲ,推荐强度:C) 目前CI尚无统一定义,通常表现为妊娠中期无痛性、进行性宫颈管缩短或宫颈扩张,导致羊膜囊膨出和/或胎膜破裂,无法维持妊娠至足月的一种宫颈无能状态。CI发病率为0.5%~1%,且呈逐年上升趋势[3]。CI的病理生理机制尚不明确,临床上常见的高危因素包括先天性因素,如子宫畸形、宫颈发育不良、苗勒管发育异常及结缔组织病等;以及获得性因素,如宫颈手术创伤(如宫颈锥切术)、机械性宫颈扩张及分娩性宫颈裂伤等。然而,大多数CI患者并未发现明确病因[3]。 目前CI尚无统一的诊断方法。尽管既往研究提出了多种方法用于诊断CI,如通过子宫输卵管造影术评估宫颈管宽度、8号或9号宫颈扩张棒是否能无阻力通过宫颈内口、测量Foley导管或宫颈球囊通过宫颈内口所需的力量[4-8],但这些方法均无法达到诊断标准。对于CI的诊断,目前需结合病史、临床表现、体格检查和超声检查,并且排除感染或其他导致妊娠中期流产或早产的原因。 超声测量宫颈长度是诊断CI的重要辅助方法,建议对高危人群超声动态监测宫颈长度和宫颈形态。超声测量宫颈长度主要有经腹、经阴道及经会阴途径,虽然3种途径测量均具有较好的相关性,但绝大多数临床研究均以经阴道超声测量值作为干预及疗效评价标准,并且制定了经阴道超声测量宫颈长度标准建议[9]。一般认为宫颈长度低于相同孕期第10百分位可以作为短宫颈的界值,在孕18~24周宫颈长度第10百分位≤25 mm[10]。鉴于我国国情以及尚不清楚对早产低风险人群常规经阴道超声筛查宫颈长度是否符合卫生经济学原则,本共识对早产低风险人群不推荐在妊娠中期常规经阴道超声筛查宫颈长度。

二、预防性宫颈环扎术的指征和手术时机

推荐意见2-1:既往有3次及以上妊娠中期自然流产史或sPTB史的单胎孕妇推荐行预防性宫颈环扎术,通常建议于11~14周进行,尽量不要超过16周。(证据等级:Ⅰ,推荐强度:A) 推荐意见2-2:既往有小于3次妊娠中期自然流产史或sPTB史的单胎孕妇,本次妊娠可选择超声监测宫颈长度。(证据等级:Ⅱ,推荐强度:A) 推荐意见2-3:既往有1次典型妊娠中期无痛性宫颈扩张致流产者,本次妊娠可考虑预防性宫颈环扎术。(证据等级:Ⅲ,推荐强度:C) 基于病史诊断为CI的妇女,可考虑行预防性宫颈环扎术(即病史指征宫颈环扎术)。一项系统综述纳入9项多中心随机对照试验(randomized controlled trial,RCT)、共2 415名CI孕妇,发现在单胎孕妇中,与未行宫颈环扎组相比,宫颈环扎组妊娠37、34和28周前早产风险显著降低(RR=0.77,95%CI:0.66~0.89)[11]。一项涵盖1 292名妇女的国际多中心RCT研究显示对于有3次及以上妊娠中期自然流产史或sPTB史者,预防性宫颈环扎术显著降低33周前sPTB发生率;但对于有≤2次妊娠中期流产史或sPTB史的孕妇,预防性宫颈环扎术并没有明显获益[12]。但因目前证据时间跨度较大、数量有限,且结合我国临床实践特点,若孕妇仅有1次妊娠中期无痛性宫颈扩张导致的流产史,且高度符合CI的诊断,也可考虑行预防性宫颈环扎术。 预防性宫颈环扎术可考虑在孕11~14周进行。尽管手术时机可能会因各种原因延迟,但尽量不要晚于孕16周。此外,宫颈环扎手术时间需同时考虑前次妊娠流产或sPTB孕周,尤其是对于妊娠丢失时间越来越提前的患者[3]。

三、超声指征宫颈环扎术的指征和手术时机

推荐意见3-1:既往有妊娠中期自然流产或sPTB史孕妇若未行预防性宫颈环扎术,推荐孕期定期超声监测宫颈长度,若24周前宫颈长度≤25 mm,推荐宫颈环扎术。(证据等级:Ⅰ,推荐强度:A) 推荐意见3-2:既往无妊娠中期流产史或sPTB史的单胎孕妇,若24周前宫颈长度≤25 mm,不推荐常规行宫颈环扎术,建议使用阴道孕酮,并动态监测宫颈长度;阴道孕酮使用后宫颈仍然持续缩短宫颈长度≤10 mm者,推荐行宫颈环扎术。(证据等级:Ⅱ,推荐强度:B) 一项纳入既往有妊娠中期(17+0~33周+6)自然流产史或sPTB史单胎孕妇的多中心RCT研究共302名孕妇,对于在16+0~21周+6常规行宫颈超声筛查时发现宫颈长度24周超声检查发现宫颈长度≤25 mm的孕妇,目前没有证据显示宫颈环扎术可获益。一项来自4项RCT研究共纳入妊娠24~26周发现短宫颈的131例单胎孕妇(66例行宫颈环扎术,65例未行宫颈环扎术)的meta分析,结果显示2组37、34、32和28周前早产率以及新生儿围产期死亡率差异均无统计学意义[22]。但该研究样本量较小,结果可能存在偏倚,需要多中心、大样本RCT研究进一步明确。因此,本共识对于孕24周后短宫颈孕妇是否行宫颈环扎术不做推荐。

四、紧急宫颈环扎术的指征和手术时机

推荐意见4-1:对妊娠中期(10 mm的双胎孕妇,宫颈环扎术能明显延长孕周,并降低早产率;然而对于以病史或仅以双胎为指征的宫颈环扎术,环扎效果并不确切[63]。另一项关于宫颈环扎术在双胎短宫颈及宫颈扩张患者中应用的meta分析,共纳入18项研究包括1 465例双胎妊娠,亦得出了类似的结论;同时发现宫颈长度在15~25 mm人群,宫颈环扎术并不能降低早产率及延长孕周[64]。但最近研究发现对超声提示宫颈长度≤25 mm的双胎妊娠孕妇实施宫颈环扎术较保守治疗可延长孕周,改善妊娠结局[65-66]。总体而言,针对多胎孕妇行预防性宫颈环扎术的高质量证据仍然非常有限。

十五、其他特殊人群

推荐意见15-1:在没有其他危险因素人群中,既往有宫颈手术史(活检、环形电切、冷刀锥切、激光消融术)或多次宫颈扩张手术史的孕妇,宫颈环扎术作用尚不确定。(证据等级:Ⅱ,推荐强度:B) 目前已有研究证实宫颈锥切术是早产的高危因素[67-71]。一项纳入27项回顾性队列研究的meta分析显示,与未接受治疗相比,宫颈冷刀锥切术后(14%与5%,RR=2.59,95%CI:1.8~3.72)及宫颈环形电切术后(11%与7%,RR=1.7,95%CI:1.24~2.35)再次妊娠早产风险增加,而宫颈激光消融手术没有增加早产风险[72]。另一项纳入71项研究的meta分析评估了宫颈上皮内瘤变手术治疗对产科结局的影响,并根据宫颈锥切深度进行分层分析,结果表明,手术治疗显著增加早产的风险,且随着锥切深度的增加,早产风险呈升高趋势[73]。 一项关于超声指征的宫颈环扎术meta分析,对于有宫颈活检史(n=64)与有>1次宫颈扩张/清宫术史(n=131)孕妇分别进行分析,发现宫颈环扎组与未行宫颈环扎组35周前早产率差异均无统计学意义[RR值(95%CI)分别为1.18(0.57~2.45)和0.91(0.57~1.47)][74]。对有宫颈反复扩张病史者,如多次宫腔镜操作、多次宫颈扩张术,术后妊娠且宫颈长度<25 mm是否需要实施宫颈环扎术,目前缺乏相关证据。2024年的一项回顾性匹配队列研究探讨宫腔镜下粘连松解术是否与不良妊娠结局风险增加有关,研究纳入114 142例孕妇,发现有宫腔镜治疗史女性妊娠后发生胎膜早破和医源性早产风险更高[RR值(95%CI)分别为3.02(1.97~4.64)和2.86(2.14~3.81)],且这些不良妊娠结局风险随宫腔镜操作次数增加而升高[75]。 十六、经腹宫颈环扎术(transabdominal  cerclage,TAC)的适应证 推荐意见16-1:TAC适应证:CI患者,既往有1次单胎妊娠经阴道非紧急宫颈环扎术后失败者或因解剖因素无法行经阴道宫颈环扎术者。(证据等级:Ⅱ,推荐强度:B) TAC是通过经腹手术将缝线环形缝扎于宫颈内口水平从而保持其闭合状态,又称子宫峡部环扎术[76]。该手术需要暴露两侧子宫血管,于两侧子宫颈旁无血管区进针[77],使缝线位于子宫主韧带及骶韧带上方,从而在宫颈内口水平提供支撑并防止缝线移位,可保留缝线于后续妊娠。随着腹腔镜手术逐步成熟,该手术可在腹腔镜下进行[78]。通常使用不可吸收编织线带、直针及举宫器来完成手术[79]。该手术也可经阴道途径进入盆腔来实现[80],亦可通过手术机器人完成[81]。 一般认为TAC手术风险相对较高且往往需要剖宫产分娩,因而该方法未被推荐作为CI的一线治疗方法[82]。对于CI且既往有经阴道预防性宫颈环扎术失败者,需要充分评估后推荐TAC。对于CI患者,即使接受了经阴道预防性宫颈环扎术,若仍发生sPTB或未足月胎膜早破,并最终在28周前分娩,可认为前次经阴道宫颈环扎术失败。该类患者是TAC最常见的适应证。一项来自英国的RCT研究,共纳入139例既往有1次低位经阴道非紧急宫颈环扎术失败史的孕前或妊娠14周前女性,随机分为TAC组、重复低位经阴道宫颈环扎术组及高位经阴道宫颈环扎术组。最终111例孕妇完成分析,结果显示,TAC组孕32周前早产率显著低于经阴道宫颈环扎组(8%与38%)[83]。根治性宫颈切除术作为早期宫颈癌保留生育功能手术,术后流产及早产风险极高。基于系列观察性研究认为预防性TAC应该作为根治性宫颈切除患者预防早产的必要措施[84]。

十七、TAC的手术时机及路径

推荐意见17-1:推荐孕前行TAC手术以降低手术风险,错过孕前环扎时机的患者可在孕早期或中孕早期实施。(证据等级:Ⅰ,推荐强度:A) 推荐意见17-2:TAC手术路径主要包括腹腔镜及开腹,手术路径选择取决于手术医生及患者情况。(证据等级:Ⅱ,推荐强度:B) 通常TAC可在孕前或者孕早期进行。孕前行TAC有以下优点:子宫相对较小,血供较少,并可放置举宫器,从而使解剖结构更清晰,手术更方便,避免了手术及麻醉对妊娠及胎儿的可能风险。孕期行TAC后有发生妊娠丢失风险,腹腔镜手术发生率为1.2%,而开腹手术为3%[79]。因此,对于指征明确的患者,优先考虑孕前环扎。尽管如此,仍有相当一部分患者就诊时已妊娠,需要行孕期TAC。 在过去10至15年间,采用传统腹腔镜、机器人辅助及单孔腹腔镜都可以实施TAC,这些微创方法促进了TAC的可行性和普及程度[75-78]。一项系统综述分析发现孕前TAC较多选择腹腔镜手术,而孕期TAC较多选择开腹手术,可能与孕期子宫增大导致腹腔镜操作难度增加有关[79]。一项包括678例TAC的meta分析显示孕前与孕期TAC有相似的活产率,但孕期TAC并发症发生率增加[85]。 多数研究将孕期TAC手术时机定在早孕期,尤其是选择腹腔镜手术。术者偏好及孕周往往影响孕期TAC手术方法选择,随着孕周增加,多数术者倾向于开腹TAC,甚至孕22周时仍可行TAC[86-87]。为降低孕期腹腔镜TAC手术难度、并发症发生率以及适用于更大孕周,日本学者对孕期腹腔镜TAC方法进行改良,并取得相似效果[88];国内学者亦提出改良的孕期腹腔镜TAC方法,极大降低了手术难度及并发症风险,手术效果确切,最大手术孕周可达15周[89]。

十八、TAC后流产或引产

推荐意见18-1:TAC后发生妊娠丢失如流产或死胎等,可依据孕周行保留TAC缝线的吸刮或扩刮术,或者行经腹腔镜或开腹拆除缝线后按产科引产处理。(证据等级:Ⅲ,推荐强度:C) TAC术后可能发生各种妊娠丢失情况,如自然流产、稽留流产、不全流产及治疗性流产等。早期妊娠丢失可以通过吸刮术终止妊娠,并保留TAC缝线于原位。一项纳入142例TAC患者的研究显示,共发生19例妊娠丢失,均采用吸刮术进行处理,其中最大孕周为19周。并且保留TAC缝线的病例在接受吸刮术后,后续妊娠仍能达到足月或近足月分娩[90]。对于TAC后死胎或胎儿畸形需要终止妊娠者,可通过腹腔镜、开腹甚至经阴道拆除缝线后按常规引产经阴道分娩[91-92]。 TAC后孕妇发生未足月胎膜早破、宫颈扩张等情况报道较少。一项回顾性研究显示TAC后失败即妊娠丢失或极早产的发生率为7%,其确切原因不明[93]。因此,对于TAC失败患者,需要充分评估,甄别可能原因,从而为后续妊娠管理提供帮助。

十九、TAC后的分娩时机及分娩方式

推荐意见19-1:TAC后妊娠,建议孕37~39周择期剖宫产分娩。(证据等级:Ⅲ,推荐强度:C) TAC后妊娠需要评估分娩时机。有文献报道TAC后孕妇临产后可能发生子宫撕裂甚至子宫破裂[90,94]。故建议在临产前及时剖宫产分娩,多数研究建议在37~38周择期剖宫产分娩,也有延至39周分娩[94]。对于有再次妊娠需求的患者,建议剖宫产术中保留TAC缝线。研究表明,该处理方式对后续妊娠结局的影响与不保留者相当,且即使未再次妊娠,其远期并发症的发生率亦极低[95]。因此对于完成妊娠的TAC患者,剖宫产时仍可保留TAC缝线,除非患者确认不再生育。 由于经典的TAC一般需剖宫产终止妊娠,也有学者提出了一些改良术式将线结置于阴道,以便分娩前经阴道拆除缝线[96-97]。由于上述方法对环扎缝线位置进行了调整,需要进一步验证其临床效果。 本共识所有推荐意见汇总见表2。 执笔专家:罗琼(浙江大学医学院附属妇产科医院)、时春艳(北京大学第一医院) 参与本共识制定讨论专家(按姓名拼音排序):蔡雁(哈尔滨医科大学附属第四医院)、陈慧(中山大学孙逸仙纪念医院)、陈敦金(广州医科大学附属第三医院)、冯玲(华中科技大学同济医学院附属同济医院)、高岩(四川省妇女儿童医院)、顾蔚蓉(复旦大学附属妇产科医院)、何津(吉林大学第一医院)、贺芳(广州医科大学附属第三医院)、胡雅毅(四川大学华西第二医院)、刘铭(同济大学附属东方医院)、刘兴会(四川大学华西二院)、罗琼(浙江大学附属妇产科医院)、孟海霞(内蒙古医科大学附属医院)、米阳(西北妇女儿童医院)、漆洪波(重庆医科大学附属第一医院)、乔宠(中国医科大学附属盛京医院)、时春艳(北京大学第一医院)、王志坚(广州医科大学附属第三医院)、魏瑗(北京大学第三医院)、魏玉梅(北京大学第一医院)、熊钰(复旦大学附属妇产科医院)、杨慧霞(北京大学第一医院)、应豪(同济大学附属妇产科医院)、张卫社(中南大学湘雅医院)、周玮(重庆医科大学附属妇女儿童医院)、曾晓明(江西省妇幼保健院) 秘书组:赵柏惠(浙江大学医学院附属妇产科医院)、吕旻(浙江大学医学院附属妇产科医院)、陈诚(浙江大学医学院附属妇产科医院)、应霞(浙江大学医学院附属妇产科医院)、金能(浙江大学医学院附属妇产科医院)、邱丽萍(湖州妇幼保健院) 利益冲突  所有作者声明不存在利益冲突 参考文献: [1]Li T, Liu Z, Yang H, et al. 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中华围产医学杂志. 终版全文|宫颈机能不全诊治中国专家共识(2025版)[S/OL]. 2025.