Cerclage, Cervical

环扎术,宫颈
  • 文章类型: Journal Article
    孕中期流产和早产是一个重大的全球性问题。手术宫颈环扎术是为了防止妊娠丢失和早产。它利用单丝或编织缝合线。假设编织材料被病原菌定植,导致阴道菌群失调,感染和环扎失败。
    该研究的主要目的是检查使用单丝缝合材料而不是编织缝合材料对需要阴道宫颈环扎术的女性妊娠损失的有效性。
    优势开放随机对照试验。
    英国有75个产妇站点。
    单胎妊娠需要宫颈环扎术的妇女。
    单丝缝合线或编织缝合线。
    主要结局是妊娠丢失(流产和围产期死亡率,包括生命第一周内的任何死产或新生儿死亡)。次要结果包括早产的核心结果集。
    女性被按1:1的比例随机分配到单丝或编织环扎组,使用定制的随机服务,并根据网站进行最小化。环扎的适应症,打算使用黄体酮和计划的手术技术。纳入标准是三个或更多以前的中期流产或早产,在先前的怀孕中插入环扎术,在当前妊娠或临床医生认为有早产风险的妇女中,有中期流产或早产的病史,宫颈长度缩短。排除标准是急诊或抢救环扎术,年龄<18岁,无法给予知情同意或环扎术必须放在腹部。原始样本量是基于相对风险降低41%,从编织组的19%的妊娠损失率降低到单丝组的11%,功率为90%,α为p=0.05。独立数据监测委员会注意到试验中汇总事件的发生率低于预期,并建议将样本量增加到2050年。使用孕产妇和新生儿医疗记录中的临床记录表收集结果数据,并报告给伯明翰临床试验单位。
    共有2049名女性被随机分组,在提款和后续损失后,纳入了单丝组1005名女性和编织组993名女性的数据.两组之间的基线人口统计学相似。没有证据表明单丝和编织组之间的妊娠损失率存在差异(80/1003vs.75/993;调整风险比:1.05,95%置信区间:0.79~1.40;调整风险差:0.002,95%置信区间:-0.02~0.03)。
    该试验未收集长期儿科结局。没有安全问题。
    没有证据表明单丝缝合线和编织缝合线之间的妊娠损失有差异。
    在C-STICH(宫颈不足的环扎缝合类型及其对健康结果的影响)试验中出生的新生儿的长期随访。
    本试验注册为ISRCTN15373349。
    该奖项由美国国家卫生与护理研究所(NIHR)卫生技术评估计划(NIHR奖项编号:13/04/107)资助,并在《卫生技术评估》中全文发布。28号40.有关更多奖项信息,请参阅NIHR资助和奖励网站。
    宫颈环扎术是在怀孕期间进行的防止流产和早产的手术。宫颈环扎术有时被推荐用于在之前有早产婴儿或之前有宫颈手术的妇女。环扎手术涉及在子宫(子宫颈)的颈部插入针迹,以在怀孕期间保持其闭合并防止其过早打开。执行操作时,医生可以使用由不同材料制成的不同类型的线。用于执行操作的线称为缝线。一种缝合线类型是单股或单丝线,另一种是多丝编织线,有许多细丝线编织在一起。一些证据表明,使用单丝缝合线通过防止感染来防止妊娠损失。因此,我们进行了一项使用单丝缝合线与编织缝合线的随机对照试验,旨在减少作为常规护理一部分的环扎术妇女的妊娠损失。这些妇女同意参加这项研究,并被随机分配使用单丝或编织缝合线进行环扎术;他们计划的怀孕护理没有其他变化。从他们的医疗记录中记录并分析了他们怀孕期间发生的事情。共有2049名妇女同意参加这项研究,并同意分析她们的怀孕和新生儿结局。宫颈不足的环扎缝合类型及其对健康结局的影响表明,两种缝合线之间的妊娠损失没有差异。在接受单丝缝合的妇女中,母体败血症减少,绒毛膜羊膜炎(这是分娩期间子宫内的感染)减少,这需要进一步调查。尽管更多使用单丝线进行环扎术的女性需要进行小手术和麻醉,通常在36到37周之间,在阴道分娩前移除单丝缝合线,他们的婴儿的结局没有差异。
    UNASSIGNED: Second trimester miscarriage and preterm birth is a significant global problem. Surgical cervical cerclage is performed to prevent pregnancy loss and preterm birth. It utilises either a monofilament or braided suture. It is hypothesised that a braided material becomes colonised with pathogenic bacteria that causes vaginal dysbiosis, infection and cerclage failure.
    UNASSIGNED: The primary objective of the study was to examine the effectiveness of using a monofilament suture material as opposed to a braided suture material on pregnancy loss in women requiring a vaginal cervical cerclage.
    UNASSIGNED: Superiority open randomised controlled trial.
    UNASSIGNED: Seventy-five maternity sites across the UK.
    UNASSIGNED: Women experiencing a singleton pregnancy requiring a cervical cerclage.
    UNASSIGNED: Monofilament suture or braided suture.
    UNASSIGNED: The primary outcome was pregnancy loss (miscarriage and perinatal mortality, including any stillbirth or neonatal death in the first week of life). Secondary outcomes included the core outcome set for preterm birth.
    UNASSIGNED: Women were randomised on a 1 : 1 basis to monofilament or braided cerclage utilising a bespoke randomisation service with minimisation dependent on the site, indication for cerclage, intention to use progesterone and planned surgical technique. The inclusion criteria were three or more previous mid-trimester losses or preterm births, insertion of a cerclage in a previous pregnancy, a history of a mid-trimester loss or preterm birth with a shortened cervical length in the current pregnancy or in women who clinicians deemed at risk of preterm birth. The exclusion criteria were an emergency or rescue cerclage, age of < 18 years, being unable to give informed consent or the cerclage having to be placed abdominally. The original sample size was calculated based on a relative risk reduction of 41% from a pregnancy loss rate of 19% in the braided group to 11% in the monofilament group with 90% power and alpha at p = 0.05. The independent data monitoring committee noted a lower-than-anticipated pooled event rate within the trial and recommended an increase in sample size to 2050. The outcome data were collected using clinical record forms from the maternal and neonatal medical records and reported to Birmingham Clinical Trials Unit.
    UNASSIGNED: A total of 2049 women were randomised, after withdrawals and loss to follow-up, data on 1005 women in the monofilament group and 993 women in the braided group were included. The baseline demographics between the groups were similar. There was no evidence of a difference in pregnancy loss rates between the monofilament and braided groups (80/1003 vs. 75/993; adjusted risk ratio: 1.05, 95% confidence interval: 0.79 to 1.40; adjusted risk difference: 0.002, 95% confidence interval: -0.02 to 0.03).
    UNASSIGNED: The trial did not collect long-term paediatric outcomes. There were no safety concerns.
    UNASSIGNED: There was no evidence of a difference in pregnancy loss between a monofilament suture and a braided suture.
    UNASSIGNED: Long-term follow-up of neonates born within the C-STICH (cerclage suture type for an insufficient cervix and its effects on health outcomes) trial.
    UNASSIGNED: This trial is registered as ISRCTN15373349.
    UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/04/107) and is published in full in Health Technology Assessment; Vol. 28, No. 40. See the NIHR Funding and Awards website for further award information.
    Cervical cerclage is an operation performed in pregnancy to prevent miscarriage and preterm birth. A cervical cerclage is sometimes recommended in women who have had babies born prematurely before or who have had previous cervical surgery. A cerclage operation involves a stitch being inserted around the neck of the womb (cervix) to keep it closed during pregnancy and to prevent it opening prematurely. When performing the operation, the doctor can use different types of threads made of different materials. The threads used to perform the operation are called sutures. One suture type is a single strand or monofilament thread, and the other is a multifilament braided thread with lots of thin strands woven together. Some evidence has suggested that using a monofilament suture thread prevented pregnancy loss by preventing infection. Therefore, we performed a randomised controlled trial of the use of monofilament suture thread versus braided suture thread, aiming to reduce pregnancy loss in women who were having a cerclage as part of their routine care. The women consented to take part in the study and were randomly allocated to their cerclage performed with either a monofilament or braided suture thread; there was no other change to their planned pregnancy care. What happened in their pregnancy was recorded from their medical records and analysed. A total of 2049 women agreed to take part in the study and consented to the analysis of their pregnancy and neonatal outcomes. Cerclage suture type for an insufficient cervix and its effects on health outcomes showed that there was no difference in pregnancy loss between the two suture threads. There was decreased maternal sepsis and decreased chorioamnionitis (which is an infection inside the womb during labour) in the women who received a monofilament suture, which needs further investigation. Although more women who had a cerclage using the monofilament thread needed a small operation and an anaesthetic, often between 36 and 37 weeks, to remove the monofilament suture prior to a vaginal birth, there were no differences in the outcomes for their babies.
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  • 文章类型: Journal Article
    目的:本研究旨在探讨血象参数对宫颈环扎术孕妇早期早产(32孕周及以下)的预测价值,根据在环扎术前确定的宫颈变化。
    方法:在2010年至2020年期间,共有161例患者接受了宫颈环扎术。参与者分为三组。第1组(n=92)由接受预防性环扎的孕妇组成。第2组(n=31)包括宫颈缩短(<5mm)和/或扩张(≤3cm)的患者。第3组(n=38)包括宫颈扩张>3cm的孕妇。每组根据分娩周数进一步划分,截止日期为32周。评估人口统计学参数和实验室参数。
    结果:在第1组中,所有血象参数在低于和高于32周的分娩之间均无显着差异。在第2组中,早期早产组中环扎前的中性粒细胞与淋巴细胞比值较高(p=0.002),接收器工作特性分析的截止值为4.75。在第3组中,环扎术前的白细胞值在早期早产组中较高(p=0.005),接收器工作特性分析的截止值为13.05×103/μL。
    结论:使用血象参数预测预防性环扎孕妇的早期早产是不合适的。然而,当宫颈扩张小于或等于3cm和/或宫颈缩短小于或等于5mm时,中性粒细胞与淋巴细胞比值可以预测早期早产.当宫颈扩张超过3厘米时,白细胞值更适合预测早期早产。
    OBJECTIVE: This study aims to investigate the predictive value of hemogram parameters in early preterm delivery (32 gestational weeks and below) among pregnant women who have undergone cervical cerclage, based on cervical changes determined before the cerclage procedure.
    METHODS: Between 2010 and 2020, a total of 161 patients underwent cervical cerclage. The participants were divided into three groups. Group 1 (n=92) consisted of pregnant women who underwent prophylactic cerclage. Group 2 (n=31) included those with cervical shortening (<5 mm) and/or dilation (≤3 cm). Group 3 (n=38) comprised pregnant women with cervical dilation >3 cm. Each group was further divided based on delivery weeks, with a cutoff at 32 weeks. Demographic parameters and laboratory parameters were assessed.
    RESULTS: In Group 1, all hemogram parameters showed no significant differences between deliveries below and above 32 weeks. In Group 2, the neutrophil-to-lymphocyte ratio value before cerclage was higher in the early preterm delivery group (p=0.002), with a cutoff value of 4.75 in receiver operating characteristic analysis. In Group 3, the white blood cell value before cerclage was higher in the early preterm delivery group (p=0.005), with a cutoff value of 13.05×103/μL in receiver operating characteristic analysis.
    CONCLUSIONS: The use of hemogram parameters to predict early preterm delivery in pregnant women undergoing prophylactic cerclage is not appropriate. However, neutrophil-to-lymphocyte ratio value can predict early preterm delivery when cervical dilation is 3 cm or less and/or cervical shortening is 5 mm or less. When cervical dilation exceeds 3 cm, the white blood cell value is more appropriate for predicting early preterm delivery.
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  • 文章类型: English Abstract
    Objective: To explore the relationship between amniotic fluid and peripheral blood inflammatory factors and the pregnancy outcomes after emergency cervical cerclage, and to identify effective indicators for predicting adverse pregnancy outcomes after the procedure. Methods: A case-control study was conducted, including pregnant women who were hospitalized at Sun Yat-sen Memorial Hospital, from January 1, 2013, to July 31, 2019, and underwent emergency cervical cerclage due to cervical dilatation at gestational age between 16 and 28 weeks. A total of 85 pregnant women who underwent amniocentesis for the detection of amniotic fluid inflammatory factors during the perioperative period were included. Based on whether their baby was perinatal death, the participants were divided into the case group (28 cases with perinatal death) and the control group (57 cases with live births). Univariate logistic regression analysis was performed to identify risk factors associated with adverse pregnancy outcomes, followed by multivariate logistic regression analysis to establish a regression model and nomogram. Results: (1) The levels of tumor necrosis factor α (TNF-α), interleukin (IL)-1β, IL-6, IL-8, IL-10 in the amniotic fluid during the perioperative period and postoperative serum C-reactive protein (CRP) were significantly higher in the case group compared to the control group (all P<0.05). The case group underwent emergency cervical cerclage at an earlier gestational age compared to the control group, and their cervical dilation was greater than that of the control group (all P<0.05). However, there were no significant differences in the white blood cell counts, neutrophil percentage, and the level of preoperative CRP in the peripheral blood of pregnant women during the perioperative period (all P>0.05). (2) Univariate logistic regression analysis showed that the levels of amniotic fluid WBC, TNF-α, IL-1β, IL-2 receptor (IL-2R), IL-6, IL-8, IL-10, postoperative CRP in the peripheral blood, gestational age at cerclage and cervical dilation were associated with adverse pregnancy outcomes (all P<0.05). Multivariate regression analysis indicated that only the levels of amniotic fluid WBC and TNF-α were independent risk factors for perinatal death. (3) Based on clinical practice, a multivariate logistic regression model was constructed including the levels of amniotic fluid TNF-α, WBC, gestational age at cervical cerclage, and cervical dilation. A nomogram and calibration curve were plotted, which suggested its good predictive value for adverse pregnancy outcomes. Conclusions: During the perioperative period of emergency cervical cerclage, the levels of amniotic fluid WBC, TNF-α, IL-1β, IL-2R, IL-6, IL-8, IL-10 are associated with adverse pregnancy outcomes, with amniotic fluid WBC and TNF-α showing the closest relationship. However, there is no significant correlation between maternal peripheral hemogram during the perioperative period and adverse pregnancy outcomes. A model constructed by amniotic fluid TNF-α, WBC, cervical cerclage gestational age, and cervical dilation has a good predictive effect on adverse pregnancy outcomes.
    目的: 探讨羊水和外周血中炎症因子水平与紧急子宫颈环扎术孕妇妊娠结局的关系,寻找预测术后不良妊娠结局的指标。 方法: 采用病例对照研究,收集2013年1月1日至2019年7月31日于中山大学孙逸仙纪念医院住院,妊娠16~28周因子宫颈外口扩张行紧急子宫颈环扎术的孕妇,选取其中围术期行羊膜腔穿刺术并检测羊水中炎症因子的孕妇共85例。根据是否抱婴回家,分为不良结局组(28例)与活产组(57例)。采用单因素logistic回归分析寻找不良妊娠结局的相关危险因素,进一步行多因素logistic回归分析建立预测不良妊娠结局的列线图。 结果: (1)与活产组比较,不良结局组孕妇行紧急子宫颈环扎术的孕周较早[分别为(23.7±1.8)、(22.9±1.9)周],宫口扩张程度较大(中位数分别为2.0、3.0 cm),分娩孕周较早[分别为(32.8±4.0)、(25.2±2.0)周]、延长孕周时间较短(中位数分别为65.0、13.5 d),分别比较,差异均有统计学意义(P均<0.05)。(2)不良结局组紧急子宫颈环扎术围术期羊水中肿瘤坏死因子α(TNF-α)、白细胞介素(IL)1β、IL-6、IL-8、IL-10及术后外周血C反应蛋白(CRP)水平显著高于活产组(P均<0.05);而环扎术前及术后孕妇外周血白细胞计数(WBC)、中性粒细胞百分比,以及术前CRP水平的差异均无统计学意义(P均>0.05)。(2)单因素logistic回归分析显示,羊水WBC、TNF-α、IL-1β、IL-2受体(IL-2R)、IL-6、IL-8、IL-10、术后外周血CRP、环扎术孕周及宫口扩张程度与不良结局相关(P均<0.05),多因素logistic回归分析显示,仅羊水WBC、TNF-α为不良结局的独立危险因素。(3)结合临床实践,综合羊水TNF-α、WBC、环扎术孕周及宫口扩张程度构建多因素logistic回归模型,绘制列线图及校准曲线,提示该多因素logistic回归模型对不良结局的预测价值良好,曲线下面积为0.811(95%CI:0.697~0.926),预测不良结局的敏感度为0.792,特异度为0.852,阳性预测值为0.679,阴性预测值为0.912。 结论: 紧急子宫颈环扎术围术期羊水WBC、TNF-α、IL-1β、IL-2R、IL-6、IL-8、IL-10与不良结局相关,其中羊水WBC及TNF-α关系最密切。而围术期母体外周血检查指标与不良结局无明显相关性。综合羊水TNF-α、WBC、环扎术孕周及宫口扩张程度构建的列线图对不良结局有良好的预测作用。.
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  • 文章类型: Systematic Review
    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。
    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.
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  • 文章类型: Journal Article
    背景:宫颈环扎术,宫颈子宫托,和阴道孕酮都被证明可以减少高危妇女的早产(PTB),但就我们所知,尚未对3种干预措施进行随机比较.TheSuPPoRT\"Stitch,Pessary,或孕酮随机试验旨在比较妊娠中子宫颈短的女性中每次干预之间的PTB<37周的发生率。
    结果:SuppoRT是一个多中心,2015年7月1日至2021年7月1日,在英国19个产科单元进行了旨在证明等效性(等效性幅度20%)的开放标签三臂随机对照试验.无症状的单胎妊娠妇女,经阴道超声检查宫颈长度<25mm,妊娠14+0至23+6周,符合随机分组(1:1:1)接受阴道宫颈环扎术(n=128),宫颈子宫托(n=126),或阴道孕酮(n=132)。最小化变量是招募时的妊娠,体重指数(BMI),和PTB的危险因素。主要结果是PTB<37周妊娠。次要结果包括PTB<34周,<30周\',和不良的围产期结局。分析是有意治疗。共有386名妊娠14+0至23+6周宫颈长度<25mm的孕妇被随机分配到3种干预措施之一。大约67%是白人,18%的黑人种族,和7.5%的亚洲种族。平均BMI为25.6。约85%的女性先前有PTB的危险因素;39.1%的女性经历过自发性PTB或中期妊娠(>14周妊娠);45.8%的女性曾进行过宫颈手术。来自381名女性的数据可用于结果分析。使用二元回归,发现随机疗法(环扎与子宫托与阴道孕酮)对PTB<37周的主要结局具有相似的影响(39/127对38/122对32/132,p=0.4,环扎与子宫托风险差异(RD)-0.7%[-12.1至10.7],环扎与孕酮RD6.2%[-5.0至17.0],孕酮与子宫托RD-6.9%[-17.9至4.1])。同样,PTB<34周和30周没有差异,也没有不良的围产期结局。干预措施(阴道分泌物和出血)与随机接受黄体酮治疗的妇女报告的腹痛更严重之间的轻度副作用有一些差异。一小部分妇女没有按照协议接受干预;然而,符合方案和处理后的分析显示出相似的结果.主要的研究局限性是该试验对新生儿结局的影响不足,并且由于COVID-19大流行而提前停止。
    结论:在这项研究中,我们发现对于子宫颈短的女性,环扎术,子宫托,和阴道孕酮在预防PTB方面同样有效,以20%的等效余量判断。开始任何治疗将是合理的临床管理。这些结果可用作临床医生在管理宫颈短的妇女时的咨询工具。
    背景:欧盟临床试验注册。EudraCT编号:2015-000456-15,临床试验注册。欧盟。,ISRCTN注册表:ISRCTN13364447,isrctn.com.
    BACKGROUND: Cervical cerclage, cervical pessary, and vaginal progesterone have each been shown to reduce preterm birth (PTB) in high-risk women, but to our knowledge, there has been no randomised comparison of the 3 interventions. The SuPPoRT \"Stitch, Pessary, or Progesterone Randomised Trial\" was designed to compare the rate of PTB <37 weeks between each intervention in women who develop a short cervix in pregnancy.
    RESULTS: SuPPoRT was a multicentre, open label 3-arm randomised controlled trial designed to demonstrate equivalence (equivalence margin 20%) conducted from 1 July 2015 to 1 July 2021 in 19 obstetric units in the United Kingdom. Asymptomatic women with singleton pregnancies with transvaginal ultrasound cervical lengths measuring <25 mm between 14+0 and 23+6 weeks\' gestation were eligible for randomisation (1:1:1) to receive either vaginal cervical cerclage (n = 128), cervical pessary (n = 126), or vaginal progesterone (n = 132). Minimisation variables were gestation at recruitment, body mass index (BMI), and risk factor for PTB. The primary outcome was PTB <37 weeks\' gestation. Secondary outcomes included PTB <34 weeks\', <30 weeks\', and adverse perinatal outcome. Analysis was by intention to treat. A total of 386 pregnant women between 14+0 and 23+6 weeks\' gestation with a cervical length <25 mm were randomised to one of the 3 interventions. Of these women, 67% were of white ethnicity, 18% black ethnicity, and 7.5% Asian ethnicity. Mean BMI was 25.6. Over 85% of women had prior risk factors for PTB; 39.1% had experienced a spontaneous PTB or midtrimester loss (>14 weeks gestation); and 45.8% had prior cervical surgery. Data from 381 women were available for outcome analysis. Using binary regression, randomised therapies (cerclage versus pessary versus vaginal progesterone) were found to have similar effects on the primary outcome PTB <37 weeks (39/127 versus 38/122 versus 32/132, p = 0.4, cerclage versus pessary risk difference (RD) -0.7% [-12.1 to 10.7], cerclage versus progesterone RD 6.2% [-5.0 to 17.0], and progesterone versus pessary RD -6.9% [-17.9 to 4.1]). Similarly, no difference was seen for PTB <34 and 30 weeks, nor adverse perinatal outcome. There were some differences in the mild side effect profile between interventions (vaginal discharge and bleeding) and women randomised to progesterone reported more severe abdominal pain. A small proportion of women did not receive the intervention as per protocol; however, per-protocol and as-treated analyses showed similar results. The main study limitation was that the trial was underpowered for neonatal outcomes and was stopped early due to the COVID-19 pandemic.
    CONCLUSIONS: In this study, we found that for women who develop a short cervix, cerclage, pessary, and vaginal progesterone were equally efficacious at preventing PTB, as judged with a 20% equivalence margin. Commencing with any of the therapies would be reasonable clinical management. These results can be used as a counselling tool for clinicians when managing women with a short cervix.
    BACKGROUND: EU Clinical Trials register. EudraCT Number: 2015-000456-15, clinicaltrialsregister.eu., ISRCTN Registry: ISRCTN13364447, isrctn.com.
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  • 文章类型: Journal Article
    目的:确定哪些非侵入性感染指标能更好地预测宫颈环扎术后感染。以及应密切监测CC感染指标后的天数。
    方法:回顾性研究,单中心研究纳入了2021年1月至2022年12月的619例单胎妊娠患者.根据医生对CC后感染的判断,将患者分为感染组和未感染组。注册信息包括患者特征,宫颈机能不全病史,CC胎龄,手术方法(麦当劳/Shirodkar),CC的目的,妊娠中期流产/早产,感染史或危险因素,CC后第1、3、5和7天的感染指数。应用倾向评分匹配(PSM)来减少患者特征偏差。C反应蛋白(CRP)的统计学分析白细胞(WBC),中性粒细胞计数(NEU),中性粒细胞计数百分比(NEU_P),白细胞介素-6(IL-6),和降钙素原(PCT)在感染组与未感染组相比,采用卡方检验和t检验。受试者工作特征(ROC)曲线用于进一步评估CRP的诊断价值,PCT,CRP-PCT联合应用。
    结果:在纳入的619名患者中,206名患者使用PSM进行匹配并随后进行评估。CC后第1天和第3天的PCT值在两组间差异均有统计学意义(P<0.01,P<0.05)。感染组第1天的CRP水平明显高于未感染组(P<0.05)。第3天,与未感染组相比,感染组CRP平均值显著升高(P<0.05)。IL-6、WBC、NEU,和NEU_P没有产生临床显着结果。CRP的ROC曲线下面积,PCT,第1天和第3天的CRP-PCT均低于0.7。在预防性CC组中,在d1时获得的CRP和CRP-PCT的AUC值高于0.7,表明诊断准确性中等.
    结论:对于CC手术后的女性,特别是预防目的,从CC后第1天到第3天,血清CRP和PCT水平升高可能预示着潜在的术后感染,保证密切监测。
    OBJECTIVE: To identify which non-invasive infection indicators could better predict post-cervical cerclage (CC) infections, and on which days after CC infection indicators should be closely monitored.
    METHODS: The retrospective, single-center study included 619 single-pregnancy patients from January 2021 to December 2022. Patients were categorized into infected and uninfected groups based on physicians\' judgments of post-CC infections. Registered information included patient characteristics, cervical insufficiency history, gestational age at CC, surgical method (McDonald/Shirodkar), purpose of CC, mid-pregnancy miscarriage/preterm birth, infection history or risk factors, and infection indices on days 1, 3, 5, and 7 after CC. Propensity score matching (PSM) was applied to reduce patient characteristic bias. Statistical analysis of C-reactive protein (CRP), white blood cell (WBC), neutrophil count (NEU), percentage of neutrophil count (NEU_P), interleukin-6 (IL-6), and procalcitonin (PCT) in the infected group compared with the uninfected group was performed using chi-square tests and t-tests. Receiver operating characteristic (ROC) curves were used to further assess the diagnostic value of CRP, PCT, and CRP-PCT in combination.
    RESULTS: Among the 619 included patients, 206 patients were matched using PSM and subsequently assessed. PCT values on day 1 and day 3 after CC exhibited significant differences between the two groups in two statistical ways (P < 0.01, P < 0.05). The CRP levels on day 1 were significantly higher in the infected group compared to the uninfected group in two statistical ways (P < 0.05). On day 3, the mean CRP value was significantly elevated in the infected group compared to the uninfected group (P < 0.05). Analyses of IL-6, WBC, NEU, and NEU_P did not yield clinically significant results. The area under the ROC curves for CRP, PCT, and CRP-PCT on day 1 and day 3 were all below 0.7. In the preventive CC group, the AUC values of CRP and CRP-PCT obtained on d1 were found to be higher than 0.7, indicating moderate diagnostic accuracy.
    CONCLUSIONS: For women after CC surgery, especially of preventive aim, increased serum CRP and PCT levels from post-CC day 1 to day 3 may signal a potential postoperative infection, warranting close monitoring.
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  • 文章类型: Case Reports
    Recurrent pregnancy loss devastates parents and frustrates doctors, especially when the pregnancy progresses to the second trimester. Cervical insufficiency is the most common cause of second-trimester pregnancy loss. Abdominal cerclage is the treatment option for women with failed vaginally applied cervical cerclage. We report a 33-year-old para 0 with a history of nine second-trimester pregnancy losses. She had six failed transvaginal cerclages using McDonald\'s procedure. A vaginal double cervical cerclage was placed in her index pregnancy. Two mersilene tape purse-string sutures were placed in the submucosal layer of the cervix; the first 1cm below and the second at the level of the internal os. Both sutures were knotted at the 12 O\'Clock position on the cervix. She carried her pregnancy to almost term and delivered a healthy baby girl weighing 2.5kg. We recommend a transvaginal double cervical cerclage with mersilene tape using a modified McDonald\'s technique as a viable alternative to abdominal cervical cerclage. (Afr J Reprod Health 2024; 28 [6]: 117-125).
    Les fausses couches récurrentes sont dévastatrices pour les parents et frustrent les médecins, surtout lorsque la grossesse progresse jusqu\'au deuxième trimestre. L’insuffisance cervicale est la cause la plus fréquente de fausse couche au deuxième trimestre. Le cerclage abdominal est l’option de traitement pour les femmes dont le cerclage cervical appliqué par voie vaginale a échoué. Nous rapportons une para 0 de 33 ans avec des antécédents de neuf fausses couches au deuxième trimestre. Elle a eu six cerclages transvaginaux selon la procédure McDonald\'s qui ont échoué. Un double cerclage vaginal vaginal a été placé lors de sa grossesse index. Deux fils de suture en bourse en ruban de mersilène ont été placés dans la couche sous-muqueuse du col de l\'utérus ; le premier 1cm en dessous et le second au niveau de l\'os interne. Les deux sutures ont été nouées à la position 12 heures sur le col. Elle a mené sa grossesse presque à terme et a donné naissance à une petite fille en bonne santé pesant 2,5 kg. Nous recommandons un double cerclage cervical transvaginal avec du ruban de mersilène en utilisant une technique McDonald\'s modifiée comme alternative viable au cerclage cervical abdominal. (Afr J Reprod Health 2024; 28 [6]: 117-125).
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  • 文章类型: Journal Article
    目的:早产(PTB)是全球新生儿发病和死亡的主要原因,宫颈功能不全(CIC)是一个重要的贡献。宫颈环扎术(CC)是一种有效的产科干预措施。然而,许多临床因素影响手术的成功率。目的是调查和比较超声和体格检查显示宫颈环扎术患者的妊娠和新生儿结局,并探讨34周前早产的影响因素。
    方法:回顾性分析2020年1月至2022年12月南京市妇幼保健院诊断为宫颈机能不全、超声及体格检查显示经阴道宫颈环扎术患者的社会人口学特征及临床资料。评估患者的妊娠和新生儿结局。使用Studentt检验(对于正态分布数据)或Mann-WhitneyU检验(对于非正态分布数据)比较连续变量。使用卡方检验或Fisher精确检验分析分类变量。此外,采用logistic回归分析和受试者工作特征曲线评价炎症标志物与母婴结局的相关性.
    结果:这项研究包括141名接受宫颈环扎术的参与者,包括71例超声指示的环扎和70例体检指示的环扎。与超声指示的环扎组相比,从环扎到分娩的持续时间,出生体重,体检指环扎组的APGAR评分明显降低,以及<28周时的分娩率,<32周,<34周,<37周和<37周的新生儿死亡率明显高于对照组(均P<0.05)。与物理超声指示的环扎组相比,在体检显示的环扎组中,母体血液炎症标志物,如C反应蛋白(CRP),全身免疫炎症反应指数(SII)和全身炎症反应指数(SIRI)均显著升高(P<0.05)。此外,母体血液炎症标志物,如CRP,白细胞计数,血小板与淋巴细胞比率(PLR),SII,在妊娠34周前分娩的组中,SIRI和SIRI明显更高。此外,结果表明,在妊娠34周之前,双胎妊娠对早产的OR最高(OR=3.829;95%CI1.413-10.373;P=0.008),以及以下:SII水平(OR=1.001;95%CI1.000-1.002;P=0.003)和CRP水平(OR=1.083;95%CI1.038-1.131;P=0.022)。妊娠34周前早产的危险因素为双胎妊娠,SII水平升高和CRP水平升高,具有良好的综合预测价值。
    结论:在宫颈机能不全患者中,与体格检查显示的宫颈环扎术相比,超声显示的宫颈环扎术可能导致更好的妊娠结局.双胎妊娠和母体血液炎症标志物,如CRP水平和SII,与妊娠34周前早产有关。
    OBJECTIVE: Preterm birth (PTB) is the leading cause of neonatal morbidity and mortality worldwide, and cervical incompetence (CIC) is a significant contribution. Cervical cerclage (CC) is an effective obstetric intervention. However, many clinical factors affect the success rate of surgery. The objective was to investigate and compare the pregnancy and neonatal outcomes of patients who underwent ultrasound- and physical examination-indicated cervical cerclage and to explore the influencing factors of preterm delivery before 34 weeks.
    METHODS: The sociodemographic characteristics and clinical data of patients with a diagnosis of cervical incompetence who underwent ultrasound- and physical examination-indicated transvaginal cervical cerclage at Nanjing Maternal and Child Health Hospital from January 2020 to December 2022 were retrospectively analyzed. The pregnancy and neonatal outcomes of the patients were evaluated. Continuous variables were compared using Student\'s t test (for normally distributed data) or the Mann-Whitney U test (for nonnormally distributed data). Categorical variables were analysed using the chi-square test or Fisher\'s exact test. Additionally, logistic regression analyses and receiver operating characteristic curves were used to evaluate the associations of inflammatory markers with maternal and neonatal outcomes.
    RESULTS: This study included 141 participants who underwent cervical cerclage, including 71 with ultrasound-indicated cerclage and 70 with physical examination-indicated cerclage. Compared to those in the ultrasound-indicated cerclage group, the duration from cerclage to delivery, birth weight, and APGAR score in the physical examination-indicated cerclage group were significantly lower, and the rates of delivery at < 28 weeks, < 32 weeks, < 34 weeks, and < 37 weeks of gestation and neonatal mortality were significantly higher (all P < 0.05). Compared to those in the physical ultrasound-indicated cerclage group, in the physical examination-indicated cerclage group, maternal blood inflammatory markers, such as C-reactive protein (CRP), the systemic immune-inflammation index (SII) and the systemic inflammation response index (SIRI) were significantly higher (P < 0.05). Additionally, maternal blood inflammatory markers, such as the CRP, white blood cell count, platelet to lymphocyte ratio (PLR), SII, and SIRI were significantly higher in the group with delivery before 34 weeks of gestation. Furthermore, the results demonstrated that twin pregnancy had the highest OR for preterm delivery before 34 weeks of gestation (OR = 3.829; 95% CI 1.413-10.373; P = 0.008), as well as the following: the SII level (OR = 1.001; 95% CI 1.000-1.002; P = 0.003) and CRP level (OR = 1.083; 95% CI 1.038-1.131; P = 0.022). The risk factors for preterm delivery before 34 weeks of gestation were twin gestation, an increased SII level and an increased CRP level, which had good combined predictive value.
    CONCLUSIONS: In patients with cervical insufficiency, ultrasound-indicated cervical cerclage appears to lead to better pregnancy outcomes than physical examination-indicated cerclage. Twin pregnancy and maternal blood inflammatory markers, such as the CRP level and the SII, are associated with preterm delivery before 34 weeks of gestation.
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  • 文章类型: Journal Article
    目的:这项定性焦点小组研究旨在研究与环扎相关的症状,环扎术对日常功能的影响以及患者对其医疗保健体验的看法。这项研究超出了目前对环扎术的手术和产科结果的关注,从而有助于更全面地理解在极端早产和胎儿丧失的背景下个体所面临的挑战,以及环扎对生活中多个方面的影响。
    方法:参与者从阿姆斯特丹大学医学中心招募,阿姆斯特丹,荷兰或通过荷兰患者组织的网站(极端)早产。符合条件的参与者年龄≥18岁,先前有阴道和/或腹部环扎术,随后在妊娠≥34周时分娩,新生儿存活。进行了两个焦点小组讨论(FGD)。使用了预定义的格式,这是相同的阴道和腹部环扎组。国际功能分类,残疾和健康(ICF-DH)用于提供结构。结果是广泛的参与者报告了关于身体的观点,情感,和社会相关的生活质量。
    结果:在阴道环扎组(VCG)和腹部环扎组(ACG)中,分别,包括11名和8名参与者。在所有患有环扎术的参与者中,对随后的妊娠失败的恐惧是怀孕期间进行日常活动的最大限制因素。由于先前的孕中期胎儿丢失,VCG中的27%和ACG中的13%经历了再次怀孕的恐惧。大多数参与者在放置环扎后焦虑减轻(VCG=64%,ACG=75%)。行动能力降低/卧床休息(VCG=100%,ACG=75%)和失血(VCG=55%,ACG=13%)在怀孕期间经常被提及环扎术。两组中提到的其他方面是社会隔离,缺乏社会参与,以及人们认为需要放弃工作和运动。腹部环扎组的所有参与者报告缺乏有关二级保健医院怀孕期间产科管理和期望的可理解和明确的信息。二级和三级护理医院之间关于腹部环扎术后产科管理的明确沟通,例如,关于用超声波测量宫颈长度的需要,没有必要卧床休息或提供有关性活动的建议(63%)。一半的参与者需要心理支持,但没有提供给他们。
    结论:所有参与者都报告说,对随后怀孕失败的恐惧是日常生活中最大的限制因素。环扎术放置可减少焦虑。参与者提到了怀孕期间卧床休息和活动限制对社会参与和日常活动的重大影响。不幸的是,在这个问题上没有高水平的证据。患者甚至可以在整个怀孕期间从适当水平的体育锻炼中受益,以促进他们的整体健康。需要更多的证据来确定最佳的体力活动水平。需要有关产科管理的明确和明确的患者信息。
    OBJECTIVE: This qualitative focus group study aims to asses cerclage-related symptoms, the impact of a cerclage on daily functioning and patient perspectives of their healthcare experience. This study extends beyond the current focus on surgical and obstetric outcomes of a cerclage, thereby contributing to a more comprehensive understanding of the challenges faced by individuals in the context of extreme preterm birth and fetal loss and the impact of a cerclage on multiple facets in life.
    METHODS: Participants were recruited from the Amsterdam University Medical Center, Amsterdam, the Netherlands or via the website of a Dutch patient organization for (extreme) preterm birth. Eligible participants were ≥ 18 years old with a previous vaginal and/or abdominal cerclage with a subsequent delivery at ≥ 34 weeks of gestation with neonatal survival. Two focus group discussions (FGD) were performed. A predefined format was used, which was identical for both the vaginal and abdominal cerclage group. The International Classification of Functioning, Disability and Health (ICF-DH) was used to provide structure. Outcomes were a broad range of participants reported perspectives on physical, emotional, and social-related quality of life.
    RESULTS: In the Vaginal Cerclage Group (VCG) and Abdominal Cerclage Group (ACG), respectively, 11 and 8 participants were included. Fear for a subsequent pregnancy loss was the most limiting factor to perform daily activities during pregnancy in all participants with a cerclage. Fear to conceive again because of prior second-trimester fetal loss was experienced by 27% in the VCG and 13% in the ACG. The majority of participants experienced a reduction in anxiety after placement of their cerclage (VCG = 64%, ACG = 75%). Decreased mobility/bedrest (VCG = 100%, ACG = 75%) and blood loss (VCG = 55%, ACG = 13%) were frequently mentioned complaints during pregnancy with cerclage. Other aspects mentioned in both groups were social isolation, the lack of societal participation, and the perceived need to quit work and sports. All participants in the abdominal cerclage group reported a lack of comprehensible and unambiguous information about obstetric management and expectations during pregnancy in secondary care hospitals. Clear communication between secondary and tertiary care hospitals about obstetric management following an abdominal cerclage, for example, about the need for cervical length measurements by ultrasound, the need for bedrest or advice concerning sexual activity was missing (63%). Psychologic support was desired in half of all participants, but was not offered to them.
    CONCLUSIONS: The fear of a subsequent pregnancy loss was reported as the most limiting factor in daily life by all participants. Cerclage placement resulted in the reduction of anxiety. Participants mentioned a significant impact of bedrest and activity restriction during pregnancy with cerclage on social participation and daily activities. Unfortunately, no high level evidence is available on this matter. Patients might even benefit from appropriate levels of physical activity throughout their pregnancy to promote their overall well-being. More evidence is needed to determine the optimal level of physical activity. There is a need for clear and unambiguous patient information about obstetric management.
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  • 文章类型: Journal Article
    确定环扎术对双胎妊娠的影响。
    一个多中心,回顾性,队列研究使用基于网络的数据收集平台在10个三级中心进行.研究人群包括妊娠20周后分娩的双胎妊娠。在妊娠20周前有一个或两个胎儿死亡的患者被排除在外。产妇特征,包括产前宫颈长度(CL)和产科结局,是从电子病历中找到的.
    共有1,473名患者在妊娠24周前有关于CL测量的可用数据。从分析中排除了在环扎之前没有获得CL数据的7例患者。根据中期测量的CL将研究人群分为两组:CL≤2.5cm组(n=127)和CL>2.5cm组(n=1,339)。CL≤2.5cm组共纳入127例患者(8.7%),包括41.7%(53/127)接受环扎的人。CL>2.5cm组接受环扎术的患者分娩时孕龄明显低于对照组(风险比(HR):1.8;95%置信区间(CI):1.11-2.87;p=0.016)。CL≤2.5cm组接受环扎术的患者分娩时孕龄明显高于对照组(HR:0.5;95%CI:0.30-0.82;p值=.006)。
    在CL≤2.5cm的双胎妊娠中,环扎术显著延长妊娠。然而,CL>2.5cm的女性不必要的环扎可能会导致早产和组织学绒毛膜羊膜炎的风险更高,尽管这项研究的局限性在于回顾性设计.
    UNASSIGNED: To determine the effects of cerclage on twin pregnancies.
    UNASSIGNED: A multicenter, retrospective, cohort study was conducted at 10 tertiary centers using a web-based data collection platform. The study population included twin pregnancies delivered after 20 weeks of gestation. Patients with one or two fetal deaths before 20 weeks of gestation were excluded. Maternal characteristics, including prenatal cervical length (CL) and obstetric outcomes, were retrieved from the electronic medical records.
    UNASSIGNED: A total of 1,473 patients had available data regarding the CL measured before 24 weeks of gestation. Seven patients without CL data obtained prior to cerclage were excluded from the analysis. The study population was divided into two groups according to the CL measured during the mid-trimester: the CL ≤2.5 cm group (n = 127) and the CL >2.5 cm group (n = 1,339). A total of 127 patients (8.7%) were included in the CL ≤2.5 cm group, including 41.7% (53/127) who received cerclage. Patients in the CL >2.5 cm group who received cerclage had significantly lower gestational age at delivery than the control group (hazard ratio (HR): 1.8; 95% confidence interval (CI): 1.11-2.87; p = .016). Patients in the CL ≤2.5 cm group who received cerclage had a significantly higher gestational age at delivery than the control group (HR: 0.5; 95% CI: 0.30-0.82; p value = .006).
    UNASSIGNED: In twin pregnancies with a CL ≤2.5 cm, cerclage significantly prolongs gestation. However, unnecessary cerclage in women with a CL >2.5 cm may result in a higher risk of preterm labor and histologic chorioamnionitis although this study has a limitation originated from retrospective design.
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