Cerclage, Cervical

环扎术,宫颈
  • 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: 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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  • 文章类型: Journal Article
    妊娠34周之前的大多数分娩发生在没有早产史的个体中。通过经阴道超声评估中期宫颈长度是自发性早产的最佳临床预测因素之一。本咨询为无早产史的个体短宫颈的诊断和管理提供指导。以下是母胎医学协会的建议:(1)我们建议所有用于指导治疗建议的宫颈长度测量都应使用经阴道方法进行,并按照围产期质量基金会或胎儿医学基金会(GRADE1C)等组织描述的标准程序进行,(2)我们建议使用中期宫颈长度≤25毫米的宫颈长度≤25毫米的宫颈,在单胎妊娠前,我们建议在20个月妊娠的个体中诊断为21毫米(GRA包括复合制剂,不用于治疗短宫颈(1B级);(6)在没有早产史的个体中,有超声检查短宫颈(10-25毫米),我们建议不要在没有宫颈扩张的情况下放置环扎术(Grade1B);(7)我们建议不要放置宫颈阴道栓以预防单胎妊娠和子宫颈短(Grade1B)的早产;(8)我们建议不要常规使用孕酮,子宫托,或环扎术治疗宫颈缩短双胎妊娠在临床试验的背景下(等级1B)。
    Most deliveries before 34 weeks of gestation occur in individuals with no previous history of preterm birth. Midtrimester cervical length assessment using transvaginal ultrasound is one of the best clinical predictors of spontaneous preterm birth. This Consult provides guidance for the diagnosis and management of a short cervix in an individual without a history of preterm birth. The following are Society for Maternal-Fetal Medicine recommendations: (1) we recommend that all cervical length measurements used to guide therapeutic recommendations be performed using a transvaginal approach and in accordance with standardized procedures as described by organizations such as the Perinatal Quality Foundation or the Fetal Medicine Foundation (GRADE 1C); (2) we recommend using a midtrimester cervical length of ≤25 mm to diagnose a short cervix in individuals with a singleton gestation and no previous history of spontaneous preterm birth (GRADE 1C); (3) we recommend that asymptomatic individuals with a singleton gestation and a transvaginal cervical length of ≤20 mm diagnosed before 24 weeks of gestation be prescribed vaginal progesterone to reduce the risk of preterm birth (GRADE 1A); (4) we recommend that treatment with vaginal progesterone be considered at a cervical length of 21 to 25 mm based on shared decision-making (GRADE 1B); (5) we recommend that 17-alpha hydroxyprogesterone caproate, including compounded formulations, not be prescribed for the treatment of a short cervix (GRADE 1B); (6) in individuals without a history of preterm birth who have a sonographic short cervix (10-25 mm), we recommend against cerclage placement in the absence of cervical dilation (GRADE 1B); (7) we recommend that cervical pessary not be placed for the prevention of preterm birth in individuals with a singleton gestation and a short cervix (GRADE 1B); and (8) we recommend against routine use of progesterone, pessary, or cerclage for the treatment of cervical shortening in twin gestations outside the context of a clinical trial (GRADE 1B).
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  • 文章类型: Journal Article
    背景:双胎妊娠在妊娠不到28周时发生极端早产(PTB)的风险很高,这与新生儿发病和死亡的风险增加有关。目前,对于双胎妊娠和宫颈短或宫颈扩张的妇女,缺乏有效的治疗方法。在妊娠中期无症状的子宫颈短或扩张的双胎妊娠中,减少极端PTB的一种可能有效的手术方法是放置阴道环扎术。
    方法:我们设计了两项多中心随机试验,涉及荷兰的8家医院(其他国家的研究点可能会在以后添加)。根据目前的荷兰妇产科协会指南(无环扎),16岁以上双胎妊娠且无症状宫颈短≤25mm或宫颈扩张的女性将被随机分配(1:1)进行阴道环扎和标准治疗的两项试验。大小为2和4的置换块将用于最小化失衡的风险。主要结果测量是<28周的PTB。分析将通过意向治疗。第一个试验是证明短宫颈组的风险从25%降低到10%,需要招募194名患者。第二项试验表明,扩张组的风险从80%降低到35%,并将招募44名女性。将从社会角度进行成本效益分析。
    背景:这项研究已于2023年3月30日获得荷兰研究伦理委员会的批准。参与者将被要求签署知情同意书。结果将在会议上发表,并在同行评审的期刊上发表。参与者将被告知结果。
    背景:ClinicalTrials.gov,NCT05968794。
    BACKGROUND: Twin pregnancies have a high risk of extreme preterm birth (PTB) at less than 28 weeks of gestation, which is associated with increased risk of neonatal morbidity and mortality. Currently there is a lack of effective treatments for women with a twin pregnancy and a short cervix or cervical dilatation. A possible effective surgical method to reduce extreme PTB in twin pregnancies with an asymptomatic short cervix or dilatation at midpregnancy is the placement of a vaginal cerclage.
    METHODS: We designed two multicentre randomised trials involving eight hospitals in the Netherlands (sites in other countries may be added at a later date). Women older than 16 years with a twin pregnancy at <24 weeks of gestation and an asymptomatic short cervix of ≤25 mm or cervical dilatation will be randomly allocated (1:1) to both trials on vaginal cerclage and standard treatment according to the current Dutch Society of Obstetrics and Gynaecology guideline (no cerclage). Permuted blocks sized 2 and 4 will be used to minimise the risk of disbalance. The primary outcome measure is PTB of <28 weeks. Analyses will be by intention to treat. The first trial is to demonstrate a risk reduction from 25% to 10% in the short cervix group, for which 194 patients need to be recruited. The second trial is to demonstrate a risk reduction from 80% to 35% in the dilatation group and will recruit 44 women. A cost-effectiveness analysis will be performed from a societal perspective.
    BACKGROUND: This study has been approved by the Research Ethics Committees in the Netherlands on 3/30/2023. Participants will be required to sign an informed consent form. The results will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results.
    BACKGROUND: ClinicalTrials.gov, NCT05968794.
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  • 文章类型: Journal Article
    目的:本研究的目的是评估与安慰剂相比,口服益生菌对环扎术孕妇妊娠结局的影响。
    方法:本研究是一项在Yasuj进行的双盲随机临床试验,伊朗。114名接受环扎的合格参与者被随机分为接受益生菌佐剂或17α-OHP(250毫克,IM)从怀孕第16-37周开始服用安慰剂,采用“阻滞”随机方法。我们的主要结局是早产(PTB)(晚期和早期),次要结局是其他产科和新生儿结局,包括早产胎膜破裂(PPROM)。产前胎膜破裂(PROM),交货方式,和新生儿结局,包括人体测量特征和Apgar评分(1分钟和5分钟)。
    结果:结果表明,在<34岁时,两组之间的PTB没有统计学上的显着差异(15.51%vs.17.86%;P=0.73)和怀孕34-37周(8.7%vs.16.1%;P=0.22),和交货方式(P=0.09)。PPROM(8.7%与28.5%;P=0.006)PROM(10.3%vs.25%;P=0.04)与对照组相比,接受益生菌佐剂的患者显着降低。交货后,本研究的结果表明,新生儿体重无显著差异(3082.46±521.8vs.2983.89±623.89),头部情况(36.86±1.53vs.36.574±1.52),高度(45.4±5.34vs.47.33±4.92)和Apgar评分在一个(0.89±0.03vs.0.88±0.05)和五分钟(0.99±0.03vs.出生后0.99±0.03)。
    结论:我们的研究结果表明,从第16周到第37周服用Lactofem益生菌可以减少PPROM和PROM等并发症。
    OBJECTIVE: The purpose of this study is to evaluate the oral probiotic effect on pregnancy outcomes in pregnant women undergoing cerclage compared to placebo.
    METHODS: This study was a double-blind randomized clinical trial undertaken in Yasuj, Iran. 114 eligible participants who have undergone cerclage were randomly divided to either receive probiotic adjuvant or 17α-OHP (250 mg, IM) with placebo from the 16th -37th week of pregnancy by \"block\" randomization method. Our primary outcomes were preterm labor (PTB) (late and early) and secondary outcomes were other obstetrical and neonatal outcomes included preterm pre-labor rupture of membranes (PPROM), pre-labor rupture of membranes (PROM), mode of delivery, and neonatal outcomes including anthropometric characterize and Apgar score (one and fifth-minute).
    RESULTS: Results show that there are no statistically significant differences between the two groups in terms of PTB in < 34th (15.51% vs. 17.86%; P = 0.73) and 34-37th weeks of pregnancy (8.7% vs. 16.1%; P = 0.22), and mode of delivery (P = 0.09). PPROM (8.7% vs. 28.5%; P = 0.006) PROM (10.3% vs. 25%; P = 0.04) was significantly lower in patients receiving probiotic adjuvant compared to the control group. After delivery, the findings of the present study showed that there were no significant differences in newborn\'s weight (3082.46 ± 521.8vs. 2983.89 ± 623.89), head circumstance (36.86 ± 1.53vs. 36.574 ± 1.52), height (45.4 ± 5.34 vs. 47.33 ± 4.92) and Apgar score in one (0.89 ± 0.03 vs. 0.88 ± 0.05) and five minutes (0.99 ± 0.03vs. 0.99 ± 0.03) after birth.
    CONCLUSIONS: Our result has shown that the consumption of Lactofem probiotic from the 16th week until 37th of pregnancy can lead to a reduction of complications such as PPROM and PROM.
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