Center for Fetal Care and High-Risk Pregnancy, University of Chieti, Chieti, Italy.
Division of Biomedical Science, Warwick Medical School University of Warwick, University Hospital of Coventry and Warwickshire, Coventry, United Kingdom.
PLoS Med. 2023 Aug 3;20(8):e1004266. doi: 10.1371/journal.pmed.1004266. eCollection 2023 Aug.
The optimal approach to prevent preterm birth (PTB) in twins has not been fully established yet. Recent evidence suggests that placement of cervical cerclage in twin pregnancies with short cervical length at ultrasound or cervical dilatation at physical examination might be associated with a reduced risk of PTB. However, such evidence is based mainly on small studies thus questioning the robustness of these findings. The aim of this systematic review was to determine the role of cervical cerclage in preventing PTB and adverse maternal or perinatal outcomes in twin pregnancies.
Key databases searched and date of last search: MEDLINE, Embase, and CINAHL were searched electronically on 20 April 2023. Eligibility criteria: Inclusion criteria were observational studies assessing the risk of PTB among twin pregnancies undergoing cerclage versus no cerclage and randomized trials in which twin pregnancies were allocated to cerclage for the prevention of PTB or to a control group (e.g., placebo or treatment as usual). The primary outcome was PTB <34 weeks of gestation. The secondary outcomes were PTB <37, 32, 28, 24 weeks of gestation, gestational age at birth, the interval between diagnosis and birth, preterm prelabor rupture of the membranes (pPROM), chorioamnionitis, perinatal loss, and perinatal morbidity. Subgroup analyses according to the indication for cerclage (short cervical length or cervical dilatation) were also performed. Risk of bias assessment: The risk of bias of the included randomized controlled trials (RCTs) was assessed using the Revised Cochrane risk-of-bias tool for randomized trials, while that of the observational studies using the Newcastle-Ottawa scale (NOS). Statistical analysis: Summary risk ratios (RRs) of the likelihood of detecting each categorical outcome in exposed versus unexposed women, and (b) summary mean differences (MDs) between exposed and unexposed women (for each continuous outcome), with their 95% confidence intervals (CIs) were computed using head-to-head meta-analyses. Synthesis of the results: Eighteen studies (1,465 twin pregnancies) were included. Placement of cervical cerclage in women with a twin pregnancy with a short cervix at ultrasound or cervical dilatation at physical examination was associated with a reduced risk of PTB <34 weeks of gestation (RR: 0.73, 95% CI [0.59, 0.91], p = 0.005 corresponding to a 16% difference in the absolute risk, AR), <32 (RR: 0.69, 95% CI [0.57, 0.84], p < 0.001; AR: 16.92%), <28 (RR: 0.54, 95% [CI 0.43, 0.67], 0.001; AR: 18.29%), and <24 (RR: 0.48, 95% CI [0.23, 0.97], p = 0.04; AR: 15.57%) weeks of gestation and a prolonged gestational age at birth (MD: 2.32 weeks, 95% [CI 0.99, 3.66], p < 0.001). Cerclage in twin pregnancy with short cervical length or cervical dilatation was also associated with a reduced risk of perinatal loss (RR: 0.38, 95% CI [0.25, 0.60], p < 0.001; AR: 19.62%) and composite adverse outcome (RR: 0.69, 95% CI [0.53, 0.90], p = 0.007; AR: 11.75%). Cervical cerclage was associated with a reduced risk of PTB <34 weeks both in women with cervical length <15 mm (RR: 0.74, 95% CI [0.58, 0.95], p = 0.02; AR: 29.17%) and in those with cervical dilatation (RR: 0.68, 95% CI [0.57, 0.80], p < 0.001; AR: 35.02%). The association between cerclage and prevention of PTB and adverse perinatal outcomes was exclusively due to the inclusion of observational studies. The quality of retrieved evidence at GRADE assessment was low.
Emergency cerclage for cervical dilation or short cervical length <15 mm may be potentially associated with a reduction in PTB and improved perinatal outcomes. However, these findings are mainly based upon observational studies and require confirmation in large and adequately powered RCTs.
预防双胞胎早产(PTB)的最佳方法尚未完全确立。最近的证据表明,对于超声检查宫颈长度短或体格检查宫颈扩张的双胎妊娠,放置宫颈环扎术可能与降低 PTB 风险相关。然而,这些证据主要基于小型研究,因此对这些发现的可靠性提出了质疑。本系统评价的目的是确定宫颈环扎术在预防双胞胎妊娠早产和不良母婴或围产儿结局中的作用。
我们在 2023 年 4 月 20 日对 MEDLINE、Embase 和 CINAHL 等关键数据库进行了电子检索,并对最后一次检索日期进行了搜索。纳入标准包括:评估接受环扎术与未接受环扎术的双胎妊娠中 PTB 风险的观察性研究,以及将双胎妊娠随机分配至环扎术预防 PTB 或分配至对照组(例如,安慰剂或常规治疗)的随机试验。主要结局是<34 周的早产。次要结局包括<37、32、28 和 24 周的早产、出生时的胎龄、诊断与分娩之间的间隔时间、早产胎膜早破(pPROM)、绒毛膜羊膜炎、围产儿丢失和围产儿发病率。还根据环扎术的适应证(宫颈长度短或宫颈扩张)进行了亚组分析。使用 Cochrane 偏倚风险评估工具(Revised Cochrane risk-of-bias tool for randomized trials)对纳入的随机对照试验(RCT)进行了偏倚风险评估,而使用纽卡斯尔-渥太华量表(Newcastle-Ottawa scale,NOS)对观察性研究进行了偏倚风险评估。使用直接比较荟萃分析计算了暴露与未暴露女性中每个分类结局的检测可能性的汇总风险比(RR),以及(b)暴露与未暴露女性之间每个连续结局的汇总平均差异(MD)及其 95%置信区间(CI)。
纳入了 18 项研究(1465 例双胎妊娠)。对于超声检查宫颈长度短或体格检查宫颈扩张的双胎妊娠妇女,放置宫颈环扎术与降低<34 周的早产风险相关(RR:0.73,95%CI [0.59,0.91],p = 0.005,即绝对风险差异为 16%,AR)、<32 周(RR:0.69,95%CI [0.57,0.84],p < 0.001;AR:16.92%)、<28 周(RR:0.54,95%CI [0.43,0.67],0.001;AR:18.29%)和<24 周(RR:0.48,95%CI [0.23,0.97],p = 0.04;AR:15.57%)的早产风险以及延长出生时的胎龄(MD:2.32 周,95%CI [0.99,3.66],p < 0.001)。对于宫颈长度短或宫颈扩张的双胎妊娠妇女,宫颈环扎术还与降低围产儿丢失(RR:0.38,95%CI [0.25,0.60],p < 0.001;AR:19.62%)和复合不良结局(RR:0.69,95%CI [0.53,0.90],p = 0.007;AR:11.75%)的风险相关。对于宫颈长度<15mm 的女性(RR:0.74,95%CI [0.58,0.95],p = 0.02;AR:29.17%)和宫颈扩张的女性(RR:0.68,95%CI [0.57,0.80],p < 0.001;AR:35.02%),宫颈环扎术与降低<34 周的早产风险相关。环扎术与预防早产和不良围产儿结局之间的关联主要归因于纳入了观察性研究。GRADE 评估的检索证据质量较低。
对于宫颈扩张或宫颈长度<15mm 的紧急环扎术可能与降低早产风险和改善围产儿结局相关。然而,这些发现主要基于小型研究,需要在大型和充分有力的 RCT 中进行证实。