Abstract：
BACKGROUND: The management of women with premature cervical dilatation and exposed unruptured fetal membranes remains uncertain and controversial. Treatment options may include expectant management or emergency cervical cerclage (ECC). Little is known regarding the effectiveness of individual interventions, or additional therapies. This systematic review aims to summarise all existing evidence to improve understanding of the treatment options and pregnancy outcomes for women presenting with premature cervical dilatation.
METHODS: Databases were searched using a prospective protocol (CRD42021286275). Studies were eligible for inclusion across five distinct comparison groups if they included women with premature cervical dilatation and reported clinical outcomes. Primary outcome was pregnancy loss (miscarriage, stillbirth, neonatal death and termination of pregnancy). Planned subgroups included singletons and twins, and low-cervical or high-cervical suture. Pairwise random effects meta-analysis calculated in RevMan5.4, single arm random effects proportional meta-analysis calculated using RevMan and R studio. Risk of bias was assessed using Cochrane Risk of Bias tool and Joanna Briggs Institute checklists.
RESULTS: 6781 abstracts were screened, and 177 (four randomised controlled trials) studies included in the five analysis groups. Women receiving ECC were significantly less likely to experience pregnancy loss (combined RR 0.48 95 %CI 0.39-0.59 singleton RR 0.48 95 %CI 0.34-0.67 twin only RR 0.39 95 %CI 0.26-0.58) compared to expectant management. Adjuvant amnioreduction with ECC was not found to reduce pregnancy loss (RR 1.12 (95 % CI 0.73-1.72) or any other outcomes compared to ECC without amnioreduction. Women were significantly more likely to experience pregnancy loss (RR3.85 95 %CI 3.13-4.74) after ECC compared to planned cerclage. The probability of intra-operative rupture of membranes at ECC insertion was 3.3 % (95 %CI 1.8-5.1) and the probability of an ECC attempt being abandoned was 2.6 % (95 %CI 1.1-4.6 %).
CONCLUSIONS: ECC appears to reduce the risk of pregnancy loss for both singletons and twins although the overall quality of evidence is poor. It is important that women are counselled regarding the outcomes following cerclage according to indication. Pregnancy complications are common after ECC although the rates of intra-operative complications are lower than may be anticipated. Randomised trials remain imperative for understanding the role of ECC and adjunctive treatments in preventing pregnancy loss in this condition.
METHODS: Databases were searched using a prospective protocol (CRD42021286275). Studies were eligible for inclusion across five distinct comparison groups if they included women with premature cervical dilatation and reported clinical outcomes. Primary outcome was pregnancy loss (miscarriage, stillbirth, neonatal death and termination of pregnancy). Planned subgroups included singletons and twins, and low-cervical or high-cervical suture. Pairwise random effects meta-analysis calculated in RevMan5.4, single arm random effects proportional meta-analysis calculated using RevMan and R studio. Risk of bias was assessed using Cochrane Risk of Bias tool and Joanna Briggs Institute checklists.
RESULTS: 6781 abstracts were screened, and 177 (four randomised controlled trials) studies included in the five analysis groups. Women receiving ECC were significantly less likely to experience pregnancy loss (combined RR 0.48 95 %CI 0.39-0.59 singleton RR 0.48 95 %CI 0.34-0.67 twin only RR 0.39 95 %CI 0.26-0.58) compared to expectant management. Adjuvant amnioreduction with ECC was not found to reduce pregnancy loss (RR 1.12 (95 % CI 0.73-1.72) or any other outcomes compared to ECC without amnioreduction. Women were significantly more likely to experience pregnancy loss (RR3.85 95 %CI 3.13-4.74) after ECC compared to planned cerclage. The probability of intra-operative rupture of membranes at ECC insertion was 3.3 % (95 %CI 1.8-5.1) and the probability of an ECC attempt being abandoned was 2.6 % (95 %CI 1.1-4.6 %).
CONCLUSIONS: ECC appears to reduce the risk of pregnancy loss for both singletons and twins although the overall quality of evidence is poor. It is important that women are counselled regarding the outcomes following cerclage according to indication. Pregnancy complications are common after ECC although the rates of intra-operative complications are lower than may be anticipated. Randomised trials remain imperative for understanding the role of ECC and adjunctive treatments in preventing pregnancy loss in this condition.
摘要：
背景：宫颈过早扩张和未破裂胎膜暴露的妇女的治疗仍不确定且存在争议。治疗选择可能包括期待管理或紧急宫颈环扎术（ECC）。关于个人干预的有效性知之甚少，或其他疗法。本系统评价旨在总结所有现有证据，以提高对宫颈过早扩张妇女的治疗选择和妊娠结局的理解。
方法：使用前瞻性方案（CRD42021286275）搜索数据库。如果研究包括宫颈过早扩张的女性并报告了临床结果，则有资格纳入五个不同的比较组。主要结果是妊娠流产（流产，死产,新生儿死亡和终止妊娠）。计划的亚组包括单胎和双胞胎，和低宫颈或高宫颈缝合。RevMan5.4中计算的成对随机效应荟萃分析，使用RevMan和R工作室计算的单臂随机效应比例荟萃分析。使用Cochrane偏差风险工具和JoannaBriggs研究所检查表评估偏差风险。
结果：筛选了6781篇摘要，和177项(4项随机对照试验)研究纳入五个分析组。与预期管理相比，接受ECC的女性发生妊娠丢失的可能性显着降低（合并RR0.4895CI0.39-0.59单例RR0.4895CI0.34-0.67双胞胎仅RR0.3995CI0.26-0.58）。与没有羊膜减少的ECC相比，ECC辅助羊膜减少未发现减少妊娠丢失（RR1.12（95％CI0.73-1.72）或任何其他结果。与计划环扎相比，ECC后女性更有可能经历妊娠丢失（RR3.8595CI3.13-4.74）。ECC插入时术中胎膜破裂的概率为3.3％（95CI1.8-5.1），而ECC尝试被放弃的概率为2.6％（95CI1.1-4.6％）。
结论：尽管总体证据质量较差，但ECC似乎可以降低单胎和双胎妊娠流产的风险。重要的是，根据适应症对妇女进行环扎后的结果进行咨询。妊娠并发症在ECC后很常见，尽管术中并发症的发生率低于预期。在这种情况下，随机试验对于理解ECC和辅助治疗在预防妊娠丢失中的作用仍然至关重要。
方法：使用前瞻性方案（CRD42021286275）搜索数据库。如果研究包括宫颈过早扩张的女性并报告了临床结果，则有资格纳入五个不同的比较组。主要结果是妊娠流产（流产，死产,新生儿死亡和终止妊娠）。计划的亚组包括单胎和双胞胎，和低宫颈或高宫颈缝合。RevMan5.4中计算的成对随机效应荟萃分析，使用RevMan和R工作室计算的单臂随机效应比例荟萃分析。使用Cochrane偏差风险工具和JoannaBriggs研究所检查表评估偏差风险。
结果：筛选了6781篇摘要，和177项(4项随机对照试验)研究纳入五个分析组。与预期管理相比，接受ECC的女性发生妊娠丢失的可能性显着降低（合并RR0.4895CI0.39-0.59单例RR0.4895CI0.34-0.67双胞胎仅RR0.3995CI0.26-0.58）。与没有羊膜减少的ECC相比，ECC辅助羊膜减少未发现减少妊娠丢失（RR1.12（95％CI0.73-1.72）或任何其他结果。与计划环扎相比，ECC后女性更有可能经历妊娠丢失（RR3.8595CI3.13-4.74）。ECC插入时术中胎膜破裂的概率为3.3％（95CI1.8-5.1），而ECC尝试被放弃的概率为2.6％（95CI1.1-4.6％）。
结论：尽管总体证据质量较差，但ECC似乎可以降低单胎和双胎妊娠流产的风险。重要的是，根据适应症对妇女进行环扎后的结果进行咨询。妊娠并发症在ECC后很常见，尽管术中并发症的发生率低于预期。在这种情况下，随机试验对于理解ECC和辅助治疗在预防妊娠丢失中的作用仍然至关重要。
