Physical Examination-indicated Cerclage Research Articles

Efficacy of physical examination-indicated cerclage in twin pregnancies compared with singleton pregnancies: a systematic review and meta-analysis.

To compare the pregnancy outcomes of physical examination-indicated cerclage (PEIC) between twin and singleton pregnancies with acute cervical insufficiency. We searched Medline, Ovid, Scopus, EBSCO, ClinicalTrials.gov and the Cochrane Central Register of Controlled Trials from their commencement until Dec 2019 for relevant studies. Patient-level data abstraction and analysis were done by two independent authors. A total of five studies with 786 women were included in the final analysis. The pooled outcomes showed that PEIC was associated with a similar reduction in preterm birth (PTB) at <32 (Risk ratio [RR] 0.93, 95% CI 0.79-1.11, I2=0%, P=0.43), and 28 (RR 1.03, 95% CI 0.82-1.29, I2=0%, P=0.81) weeks of gestation; however, a much higher frequency of PTB was observed at <36 (RR 0.74, 95% CI 0.66-0.83, I2=0%, P<0.000), and 34 (RR 0.80, 95% CI 0.68-0.93, I2=0%, P=0.004) weeks of gestation in twin pregnancies than in singleton pregnancies. No significant differences in perinatal outcomes, including neonatal death (RR 1.03, 95% CI 0.64-1.67, I2=52%, P=0.900), stillbirth (RR 0.73, 95% CI 0.37-1.44, I2=0%, P=0.360), perinatal mortality (RR 0.94, 95% CI 0.65-1.38, P=0.760) and neonatal complications were found between twin and singleton pregnancies. Our meta-analysis indicated that PEIC achieved good perinatal prognosis in both singleton and twin pregnancies. However, because the available evidence is insufficient to attain a strong conclusion, so further high-quality trials are needed to confirm our findings.

Latencia al parto tras cerclaje de emergencia en gestación múltiple

IntroductionCurrent guidelines support the use of physical-examination indicated cerclage (PEIC) as a treatment for cervical insufficiency and membrane exposure in single pregnancies. However, PEIC in twin pregnancies is a controversial issue as no data from random clinical trial are available to demonstrate its efficacy. Few studies suggest that PEIC may prolong pregnancy also in twin pregnancies. The aim of this study was to evaluate the results of twin pregnancies that underwent a PEIC in our health centre. Material and methodsA retrospective review was performed on women that underwent a PEIC from 2007-2016 in our centre. Women were not eligible if they were carrying foetuses with major foetal anomalies, more than two foetuses or monochorionic-monoamniotic pregnancies, or three or more foetuses or requesting an elective termination of pregnancy. Primary outcomes: latency to spontaneous delivery and gestational age (GA) at delivery. Secondary outcomes: neonatal mortality and Neonatal Intensive Care Unit admission, preterm premature rupture of membranes (PPROM), chorioamnionitis and cerclage displacement. ResultsThe study included a total of 17 women. The median (inter-quartile range) gestational age at delivery was 27.1 (24.5-32.3) weeks, and median (inter-quartile range) latency, from cervical cerclage to delivery, was 43 (21-64) days. There were 4/17 (23.5%) cases of delivery before 24 weeks of pregnancy, and 2/26 (7.7%) cases of neonatal death. DiscussionThese results suggest that latency to delivery after PEIC in twins is remarkable. Therefore, it could be considered as an optional management. Nevertheless, evidence based on random clinical trial is required to make firm recommendations on its formal use.

Influence of preoperative light vaginal bleeding for perinatal adverse outcomes on physical examination-indicated cerclage

Purpose To clarify the relationship between light vaginal bleeding (LVB) before physical examination-indicated cerclage (PEIC) and perinatal adverse outcomes. Methods This was a retrospective cohort study involving 94 singleton pregnancies undergoing PEIC <26 weeks of gestation at a single perinatal medical center between 2008 and 2015. The primary outcome was set as spontaneous preterm birth (sPTB) <34 weeks of gestation. The secondary outcomes were set as the second-trimester loss prior to 22 weeks of gestation, sPTB before 28 weeks of gestation, sPTB before 37 weeks of gestation, and stillbirth or neonatal death. Relationships between LVB and adverse outcomes were evaluated using logistic regression analysis. Results Preoperative LVB was detected in 16 cases (17.0%). Multivariate logistic regression analyses revealed that preoperative LVB was an independent risk factor for sPTB <34 weeks of gestation (adjusted odds ratio [aOR]: 8.42; 95% confidence interval [CI]: 1.72–41.1; p < .01), sPTB <28 weeks of gestation (aOR: 5.98; 95% CI: 1.67–21.4; p < .01) and perinatal death (aOR: 8.47; 95% CI: 1.11–64.5; p = .04). Conclusions Vaginal bleeding prior to PEIC, even nonsignificant or self-limiting, is associated with sPTB before 28 or 34 weeks of gestation and perinatal death.

470: Comparison of physical examination and ultrasound indicated cerclages between singleton and twin pregnancies

Physical examination indicated cerclage (PEIC) and Ultrasound indicated cerclage (UIC) are well stablished strategies for reducing preterm birth in singleton pregnancies. However, their indication in twin pregnancies is a controversial issue as no data from RCT are available to demonstrate their efficacy. The aim of this study was to compare perinatal outcomes after PEIC and UIC between singleton and twin gestations. Retrospective observational study including patients having PEIC or UIC in Hospital Clinic of Barcelona, from 2007 to 2016. Exclusion criteria were: monochorionic-monoamniotic placentation, major fetal anomalies and elective termination of pregnancy. Wilcoxon-test and Chi-square and Fisher’s exact test were used to compare continuous and categorical variables, respectively. Differences were considered statistically significant when p-value <0.05. 129 women with cercalge were evaluated. 60 women (43 singletons and 17 twins) underwent PEIC, and 2singleton pregnancies were lost to follow-up. 69women (56 singleton and 13 twins) underwent UIC, and 7 (6 singleton and 1 twin) were lost to follow up. Basal characteristics were similar between both PEIC groups, except that there were more twin pregnancies conceived by ART. Between UIC groups, there were more nulliparous and women with a previous preterm birth among twin pregnancies. Perinatal outcomes of PEIC and UIC are shown in Tables 1 and 2, respectively. No significant differences in the perinatal outcomes between singleton and twin pregnancies who underwent PEIC were observed. Regarding UIC, and despite latency to delivery in twins with UIC was significantly shorter compared to singletons, latency to delivery reached a median of 12 weeks. More PPROM and NICU admission were observed in twin pregnancies who underwent a UIC. Outcomes of PEIC were comparable between singleton and twin pregnancies. Outcome of UIC in twins show worse results compared to singletons but latency to delivery is still clinically relevant. Therefore, PEIC and UIC in twin pregnancies deserve further study as they may play a role as a therapeutic approach.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Amniotic fluid HIF1α and exosomal HIF1α in cervical insufficiency patients with physical examination-indicated cerclage

Objective: Hypoxia inducible factor 1α (HIF1α) has been reported to activate inflammatory cascade. Recently, exosomes have been known to have pivotal roles in intercellular communication. The aim of this study was to compare the concentration of amniotic fluid (AF) HIF1α, exosomal HIF1α, and inflammatory cytokines such as interleukin 1α (IL1α), interleukin 1β (IL1β), interleukin 6 (IL6), and tumor necrosis factor α (TNFα) between physical examination-indicated cerclage (PEIC) and control group. We also investigated the associations between biomarkers and amniocentesis-to-delivery interval and the correlations of inflammatory cytokines, HIF1α, and exosomal HIF1α.Methods: Case-control study was performed. Cases are defined as 16 patients who underwent PEIC and controls are 19 women who underwent amniocentesis for confirming chromosomal abnormalities. The concentration of IL1α, IL1β, IL6, TNFα, HIF1α, and exosomal HIF1α were measured using enzyme-linked immunosorbent assay (ELISA). Exosomes were confirmed by tumor susceptibility Gene 101 (TSG 101) and transmission electron microscopy (TEM).Results: The mean HIF1α in PEIC group was higher than control group (PEIC, 15.03 ± 9.60-pg/mL versus control, 2.96 ± 1.99 pg/mL; p < .01). There were significant differences in inflammatory cytokines between two groups. A significant difference in exosomal HIF1α was shown between two groups (PEIC, 27.97 ± 28.61-µg/mL versus control, 12.42 ± 8.20 µg/mL; p < .01). HIF1α, IL1α, IL6, TNFα, and exosomal HIF1α showed significantly negative association with cerclage-to-delivery interval. However, IL1β was not associated with cerclage-to-delivery interval. HIF1α was positively correlated with exosomal HIF1α (rho = 0.93, p < .01). Both HIF1α and exosomal HIF1α were significantly associated with TNFα (rho = 0.94, p < .01; rho = 0.97, p < .01). Both HIF-1α and exosomal HIF1α had positive correlation with IL1α (rho = 0.96, p < .01; rho = 0.91, p < .01). However, IL1β showed no correlations with HIF1α and exosomal HIF1α. A positive correlation between HIF-1α and IL6 was observed (rho = 0.58, p = .01.) Exosomal HIF1α also had correlation with IL6 (rho = 0.52, p = .03).Conclusions: This study demonstrated that amniotic fluid (AF) HIF1α and AF exosomal HIF1α were higher in physical examination-indicated cerclage (PEIC) group than control group. AF HIF1α and AF exosomal HIF1α were associated with shorter amniocentesis-to-delivery interval. More importantly, they had positive correlations with AF inflammatory cytokines such as IL1α, IL6, and TNFα. Our results may indicate that AF HIF1α and AF exosomes interact with AF inflammatory cytokines and contribute inflammatory cascade in complicated pregnancies.

Cervical Cerclage During Periviability: Can We Stabilize a Moving Target?

The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine recently published consensus guidelines on periviable birth recommending that obstetric interventions (antenatal corticosteroids, tocolysis, magnesium sulfate, antibiotics for preterm premature rupture of membranes or group B streptococcus prophylaxis, and cesarean delivery for fetal indications) may be considered at 23 0/7 weeks of gestation and neonatal resuscitation at 22 0/7 weeks of gestation. Cervical cerclage significantly decreases preterm delivery and improves perinatal outcomes in women with a singleton pregnancy, prior spontaneous preterm birth, and transvaginal cervical length less than 25 mm before 24 0/7 weeks of gestation or in women who experience painless cervix dilation in the second trimester. Randomized trials assessing ultrasonogram-indicated and physical examination-indicated cerclage report a procedure-related complication rate of 0.3% and 0.9%, respectively. If previability is a requisite for receiving a cerclage, an increasing subset of women may not be afforded an intervention that has known benefit, because obstetric and neonatal interventions are likely to occur at earlier gestational ages. Given the low procedure-related complication rate demonstrated in randomized trials, appropriately selected women should continue to be offered the procedure up to 24 0/7 weeks of gestation. Based on current evidence, cerclage placed after 24 0/7 weeks of gestation cannot be recommended, and future inquiry in the form of a well-designed randomized trial after this gestational age should be considered. The goal of this commentary is to review the history of cerclage and discuss the indications, risks, benefits, and implications on future research of this procedure as it relates to gestational age during periviability.

Physical examination-indicated cerclage in singleton and twin pregnancies: maternal–fetal outcomes

Objectives: To study maternal and perinatal outcomes after physical examination-indicated cerclage in both singleton and twin pregnancies and evaluate the possible risk factors associated.Study design: Retrospective review of all women undergoing physical examination-indicated cerclage at the Hospital Vall d’Hebro, Barcelona from January 2009 to December 2012 after being diagnosed with cervical incompetence and risk of premature birth.Results: During the study period, 60 cases of women diagnosed with cervical incompetence who were carrying live and morphologically-normal fetuses (53 singleton and 7 twin pregnancies), and who had an imminent risk of premature birth were evaluated. Mean gestational age until birth was 35 weeks in singleton and 32 weeks in twin pregnancies. Four cases (7.5%) of immature births and one case (2.0%) of neonatal death were recorded in singleton pregnancies. No cases of immature births or neonatal deaths were recorded in twin pregnancies. Diagnostic amniocentesis was performed IN all cases to rule out possible chorioamnionitis.Conclusions: Physical examination-indicated cerclage for cervical incompetence in women at risk for immature or preterm birth demonstrates good perinatal prognosis without increasing maternal morbidity in either singleton or twin pregnancies. The increase in gestation time in our study may also have been due to the fact that patients with subclinical chorioamnionitis were excluded by diagnostic amniocentesis.

Trends in cerclage use.

The indications of placement of cerclage have recently changed, and so it is important to evaluate how many women are undergoing this procedure. With the recent completion of clinical trials, it is plausible that obstetricians and perinatologists may have become more selective in terms of the best candidates for cerclage. We conducted a retrospective cohort study of women who underwent cerclage for prevention of preterm birth in the Division of Maternal and Fetal Medicine of Thomas Jefferson University Hospital (Philadelphia, USA) over a 16-year period, from 1998 to 2013. We included women with singleton gestations who had a history-indicated (HIC) or ultrasound-indicated cerclage (UIC). Physical examination-indicated cerclage and transabdominal cerclage were excluded. We planned to compare data before and after 2005. From 1998 to 2013, there were 33 353 deliveries, of which 16 871 occurred from 1998 to 2005 and 16 482 from 2006 to 2013. Of all deliveries, 328 women (1.0%) received HIC or UIC, and were therefore included in the analysis. Between 1998-2005 and 2006-2013 there were significant decreases in the overall rate of cerclage (1.4% to 0.6%; p < 0.001), as well as the rate of HIC (0.8% to 0.2%; p < 0.001) and UIC (0.6% to 0.3%; p < 0.001). During the last 16 years, the overall rate of HIC and UIC cerclage at Thomas Jefferson University Hospital significantly declined from 1.4% to 0.6%; significant decreases were seen for both HIC and UIC. The reason for the lower rate of cerclages may be the recently published evidence.

Physical Examination-Indicated Cerclage: A Systematic Review and Meta-analysis.

To estimate the effectiveness of physical examination-indicated cerclage in the setting of second-trimester cervical dilatation by systematic review and meta-analysis of published studies. We searched MEDLINE, EMBASE, Scopus, ClinicalTrials.gov, Web of Science, and the Cochrane Library for studies published between 1966 and 2014 that evaluated cervical cerclage for the treatment of cervical insufficiency. The search yielded 6,314 citations. We included cohort studies and randomized controlled trials comparing cerclage placement with expectant management of women with cervical dilatation between 14 and 27 weeks of gestation. Two investigators independently reviewed each citation for inclusion or exclusion and discordant decisions were arbitrated by a third reviewer. Summary estimates were reported as the mean difference and 95% confidence interval (CI) for continuous variables or relative risk and with 95% CI for dichotomous outcomes. Fixed- and random-effects meta-analysis was used, depending on heterogeneity. Ten studies met inclusion criteria and were included in the final analysis. One was a randomized controlled trial, two were prospective cohort studies, and the remaining seven were retrospective cohort studies. Of the 757 women, 485 (64%) underwent physical examination-indicated cerclage placement and 272 (36%) were expectantly managed. Cerclage was associated with increased neonatal survival (71% compared with 43%; relative risk 1.65, 95% CI 1.19-2.28) and prolongation of pregnancy (mean difference 33.98 days, 95% CI 17.88-50.08). Physical examination-indicated cerclage is associated with a significant increase in neonatal survival and prolongation of pregnancy of approximately 1 month when compared with no such cerclage. The strength of this conclusion is limited by the potential for bias in the included studies.

Impaired Neonatal Outcome after Emergency Cerclage Adds Controversy to Prolongation of Pregnancy.

ObjectiveEmergency cervical cerclage is one of the treatment options for the reduction of preterm birth. The aim of this study is to assess neonatal outcome after cerclage with special focus on adverse effects in very low birth weight infants.Study DesignRetrospective cohort study. Classification of cerclages in history-indicated (HIC, n = 38), ultrasound-indicated (UIC, n = 29) and emergency/ physical examination-indicated (PEIC, n = 33) cerclage. Descriptive analysis of pregnancy and neonatal outcome (admission to NICU, duration of hospitalization, respiratory outcome (intubation, CPAP, FiO2max), neonatal complications (ROP, IVH)). Statistical comparison of perinatal parameters and outcome of neonates <1500 g after cerclage with a birth weight matched control group.ResultsNeonates <1500 g after PEIC show significantly impaired outcome, i.e. prolonged respiratory support (total ventilation in days, CPAP, FiO2max) and higher rates of neonatal complications (IVH ≥ II, ROP ≥ 2). Placental pathologic evaluation revealed a significantly higher rate of chorioamnionitis (CAM) after PEIC. Neonates <1500 g after UIC or HIC show no significant difference in neonatal complications or CAM.ConclusionsIn our study PEIC is associated with adverse neonatal outcome in infants <1500 g. The high incidence of CAM indicates a potential inflammatory factor in the pathogenesis. Large well-designed RCTs are required to give conclusive answers to the question whether to prolong or to deliver.

Elective removal of cervical cerclage and onset of spontaneous labor

ObjectiveTo determine the time interval between elective removal of cervical cerclage and onset of spontaneous labor. MethodsA retrospective cohort study was conducted between January 2005 and December 2012 at a tertiary care hospital in Lisbon, Portugal. All singleton pregnancies with a McDonald or Shirodkar cerclage electively removed at 36–37weeks were evaluated for the time interval between cerclage removal and spontaneous labor. Delivery within 72hours after cerclage removal was compared between patients with elective cerclage and those with non-elective cerclage. In the non-elective group, a sub-analysis of the results for ultrasound- and physical examination-indicated cerclage was performed. ResultsThirty-eight women were included. The time interval between cerclage removal and spontaneous labor did not differ significantly between the elective and the non-elective group (15.6±7.6 vs 10.9±7.4days; P=0.063). A higher incidence of delivery 72hours after cerclage removal was seen in the non-elective group but this was not significant (P=0.061). There were no differences regarding the time interval from elective removal of cervical cerclage to onset of spontaneous labor between ultrasound-indicated and physical examination-indicated cerclage. ConclusionRegardless of the indication for cervical cerclage, the probability of delivery soon after elective cerclage removal is low.

Outcomes after physical examination-indicated cerclage in twin gestations

To compare outcomes of physical examination-indicated cerclage in women with twin gestations to those with singleton gestations and to identify whether risk factors for extremely preterm birth (before 28 weeks) differ between these 2 groups. This is a single institution retrospective cohort study of women who underwent a physical examination-indicated cerclage between Jan. 1, 1980, and Aug. 15, 2012. Differences in characteristics and outcomes were compared between women with twin and singleton gestations. A multivariable analysis was performed to examine whether twin gestation was independently associated with delivery before 28 weeks and whether any effect modification was present between risk factors for preterm birth and the presence of a twin gestation. Of the 442 women who underwent a cerclage during the period of study, 104 (23.5%) had twins. Mean gestational age and digital cervical length at placement did not differ by plurality. Although twins were more likely to deliver at a slightly earlier median gestation than singletons (31.9 weeks; interquartile range, 24.9-35.1 vs 32.7 weeks; interquartile range, 24.6-38.3; P = .015), the frequency of delivery before 28 weeks did not differ between these 2 groups (33.7% vs 35.8%, P = .69). Greater cervical dilation and prolapsing membranes were identified as risk factors for birth <28 weeks in both groups; digital cervical length <2 cm appeared to be a risk factor particularly for women with twin gestations. Women with a twin pregnancy who received a physical examination-indicated cerclage had similar risk factors for extreme preterm birth and may experience similar obstetric outcomes as women with singleton gestations.

Outcomes of emergency or physical examination-indicated cerclage in twin pregnancies compared to singleton pregnancies

ObjectiveTo report the obstetrical outcomes in patients with twin pregnancies who underwent an emergency/physical exam-indicated cerclage and to compare them to patients with singleton pregnancies undergoing the same procedure. Study designPatients who underwent emergency/physical exam-indicated cerclage in the second trimester in one maternal-fetal medicine practice from July 1997 to March 2012 were reviewed. We defined an emergency/physical exam-indicated cerclage as any cerclage placed in a patient with a dilated cervix on examination or membranes visible at the external cervical os on speculum examination. We compared outcomes between patients with singleton and twin pregnancies using non-parametric testing. ResultsThere were 43 patients (12 twin and 31 singleton pregnancies) who underwent emergency/physical exam-indicated cerclage placement. The median gestational age at cerclage placement, cervical dilation, maternal age, and cerclage type were similar between the groups. Comparing twins to singletons, the median time from cerclage placement to delivery was similar (92 vs. 106 days, p=0.330), as was the median gestational age at delivery (33.5 vs. 35.0 weeks, p=0.244). The likelihood of delivery at >32 weeks (75.0% vs. 71.0%, p>0.999) and the likelihood of neonatal survival to discharge (83.3% vs. 83.9%, p>0.999) were also similar. ConclusionsEmergency/physical exam-indicated cerclage in twin pregnancies can be associated with favorable outcomes, including a high likelihood of delivery at >32 weeks and a high likelihood of survival. Their outcomes appear similar to singleton pregnancies. Cerclage should be considered an option for patients with twin pregnancies and a dilated cervix in the second trimester.

Expectant management compared with physical examination–indicated cerclage (EM-PEC) in selected women with a dilated cervix at 14 0/7-25 6/7 weeks: results from the EM-PEC international cohort study

The objective of the study was to compare pregnancy outcomes in selected women with a dilated cervix who underwent expectant management or physical examination-indicated cerclage. This was a historical cohort study conducted by the Global Network for Perinatal and Reproductive Health. Women between 14(0/7) and 25(6/7) weeks' gestation with a dilated cervix were identified at 10 centers by ultrasound or digital examination. Primary outcome was time from presentation until delivery (weeks). Secondary outcomes were neonatal survival, birthweight greater than 1500 g and preterm birth less than 28 weeks. Multivariate regression was used to assess the likelihood of neonatal outcomes and control for confounders. Of 225 women, 152 received a physical examination-indicated cerclage, and 73 were managed expectantly without cerclage. Cervical dilation, gestational age at presentation, and antenatal steroid use differed between groups. In the adjusted analyses, cerclage was associated with longer interval from presentation until delivery, improved neonatal survival, birthweight greater than 1500 g and preterm birth less than 28 weeks, compared with expectant management. Similar results were obtained in the analyses limited to women dilated between 2 and 4 cm (n = 122). In this study, the largest cohort reported to date, physical examination-indicated cerclage appears to prolong gestation and improve neonatal survival, compared with expectant management in selected women with cervical dilation between 14(0/7) and 25(6/7) weeks. A randomized, controlled trial should be conducted to determine whether these potential benefits outweigh the risks of cerclage placement in this population.