Cervical stitch (cerclage) in combination with other treatments for preventing spontaneous preterm birth in singleton pregnancies.
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SUBMITTER: Eleje GU
PROVIDER: S-EPMC8094629 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ImportanceSpontaneous preterm birth is a major cause of perinatal morbidity and mortality. It is unclear if a cervical pessary can reduce the risk of spontaneous preterm delivery.ObjectiveTo test whether in asymptomatic women with singleton pregnancies and no prior spontaneous preterm birth but with short cervical length on transvaginal ultrasound, use of a cervical pessary would reduce the rate of spontaneous preterm birth at less than 34 weeks of gestation.Design, setting, and participantsParallel-group, nonblinded, randomized clinical trial conducted from March 1, 2016, to May 25, 2017, at a single center in Italy. Asymptomatic women with singleton gestations, no previous spontaneous preterm births, and cervical lengths of 25 mm or less at 18 weeks 0 days to 23 weeks 6 days of gestation were eligible.InterventionsPatients were randomized 1:1 to receive either cervical pessary (n = 150) or no pessary (n = 150). The pessary was removed between 37 weeks 0 days and 37 weeks 6 days of gestation or earlier if clinically indicated. The control group received standard care. For cervical length of 20 mm or shorter, women in both groups were prescribed vaginal progesterone, 200 mg/d, until 36 weeks 6 days of gestation. No bed rest or activity restriction was recommended.Main outcomes and measuresThe primary end point was spontaneous preterm birth at less than 34 weeks of gestation. Secondary outcomes were adverse events.ResultsAmong 300 women who were randomized (mean age, 29 [SD, 6.3] years; mean gestational age, 22 [SD, 1.3] weeks), 100% completed the trial. The primary end point occurred in 11 women (7.3%) in the pessary group and 23 women (15.3%) in the control group (between-group difference, -8.0% [95% CI, -15.7% to -0.4]; relative risk, 0.48 [95% CI, 0.24-0.95]). During follow-up, the pessary group had a higher rate of increased or new vaginal discharge (86.7% vs 46.0%; between-group difference, +40.7% [95% CI, +30.1%-+50.3%]; relative risk, 1.88 [95% CI, 1.57-2.27]).Conclusions and relevanceAmong women without prior spontaneous preterm birth who had asymptomatic singleton pregnancies and short transvaginal cervical length, use of a cervical pessary, compared with no pessary use, resulted in a lower rate of spontaneous preterm birth at less than 34 weeks of gestation. The results of this single-center, nonblinded study among selected pregnant women require confirmation in multicenter clinical trials.Trial registrationclinicaltrials.gov Identifier: NCT02716909.
| S-EPMC5820698 | biostudies-literature
Project description:BackgroundThis study aimed to evaluate the outcome of repeat cerclage (RC) in singleton pregnancies with prolapsed membranes following a prior cerclage and analyze predictive factors for delivery at ≥26 weeks of gestation following RC.Materials and methodsPatients who underwent RC between 2010 and 2020 at the Hallym University Medical Center were reviewed. Women with singleton pregnancies with prolapsed membranes following prior cerclage were candidates for RC. We analyzed the characteristics, pregnancy outcomes, perioperative clinical and laboratory findings, and postoperative cervical length (CL) to identify the factors for predicting delivery at ≥26 weeks following RC.ResultsThirty-five women with RC were identified; the median gestational age (GA) at a prior cerclage was 14 weeks, the average GA at RC was 21 + 3 weeks, and the median GA at delivery following RC was 26 + 2 weeks. Patients were divided into two groups based on their delivery status at 26 weeks: 17 women delivered at <26 weeks (range, 18 + 4-25 + 6 weeks) (Group A) and 18 women delivered at ≥26 weeks (range, 26 + 2-40 + 3 weeks) (Group B). The median GA at delivery in group A was 22 + 4 weeks, whereas that in group B was 33 + 4 weeks (p < 0.001). No differences in preoperative clinical and laboratory findings were observed between the two groups. However, the postoperative CL in group A was significantly shorter than that in group B (12 mm vs. 21.5 mm, p < 0.001). The ROC curve of postoperative CL predicting delivery at ≥26 weeks showed an AUC of 0.843; a CL of 20 mm showed a sensitivity of 61.1% and a specificity of 100%.ConclusionRC may prolong singleton pregnancies with prolapsed membranes following prior cerclage. A postoperative CL ≥20 mm may predict the success of RC.
| S-EPMC10475578 | biostudies-literature
Project description:The study aimed to explore the impact of cervical conization size (CCS) with subsequent cervical length (USCL) changes on preterm birth (PTB) rates in asymptomatic singleton pregnancies as compared to pregnancy outcomes in healthy women with an intact cervix (ICG), and to estimate PTB prevention efficiency in patients with a short cervix. Pregnancy outcomes in populations of similar age, ethnicity, residency, education and harmful habits having undergone cervical conization (CCG) were retrospectively analyzed and compared to ICG and cervical conization sub-populations adjusted by USCL during pregnancy (adequate cervical length vs. a short cervix) and a progesterone-only group (POG) vs. a progesterone-pessary group (PPG). Cervical conization was not associated with an increased PTB risk (CCG vs. ICG) when parameters of CCS and USCL were not adjusted (p = NS). A significantly higher proportion of parous women was observed in the CCG population than in the ICG (p = 0.0019). CCS turned out to be a key PTB risk during pregnancy, the larger CCS being associated with a short cervix (p = 0.0001) and higher PTB risks (p = 0.0001) with a notably increased PTB rate (p = 0.0001) in nulliparous women (p = 0.0022), whereas smaller CCS with adequate cervical length and a lower PTB rate was predominantly observed in women with prior parity. An initial equal USCL size was to be considerably elongated in women with adequate cervical length (p < 0.0001), and shortened in those with a short cervix (p < 0.0001). USCL assessment during pregnancy proved to be the PTB risk-predicting tool, with CCS supplementation apt to increase its diagnostic value. No substantial impact on pregnancy outcomes could be linked to any particular PTB prevention mode (POG or PPV). However, during pregnancy, the USCL changes relating to CCS proved to be more critical in pregnancy outcomes.
| S-EPMC8492699 | biostudies-literature
Project description:BackgroundPreterm birth is the leading cause of childhood mortality and morbidity. We aimed to provide a comprehensive systematic review on randomized controlled trials (RCTs) on progesterone, cerclage, pessary, and acetylsalicylic acid (ASA) to prevent preterm birth in asymptomatic women with singleton pregnancies defined as risk of preterm birth and multifetal pregnancies.MethodsSix databases (including PubMed, Embase, Medline, the Cochrane Library) were searched up to February 2022. RCTs published in English or Scandinavian languages were included through a consensus process. Abstracts and duplicates were excluded. The trials were critically appraised by pairs of reviewers. The Cochrane risk-of-bias tool was used for risk of bias assessment. Predefined outcomes including preterm birth, perinatal/neonatal/maternal mortality and morbidity, were pooled in meta-analyses using RevMan 5.4, stratified for high and low risk of bias trials. The certainty of evidence was assessed using the GRADE approach. The systematic review followed the PRISMA guideline.ResultsThe search identified 2,309 articles, of which 87 were included in the assessment: 71 original RCTs and 16 secondary publications with 23,886 women and 32,893 offspring. Conclusions were based solely on trials with low risk of bias (n = 50).Singleton pregnancies: Progesterone compared with placebo, reduced the risk of preterm birth <37 gestational weeks: 26.8% vs. 30.2% (Risk Ratio [RR] 0.82 [95% Confidence Interval [CI] 0.71 to 0.95]) (high certainty of evidence, 14 trials) thereby reducing neonatal mortality and respiratory distress syndrome. Cerclage probably reduced the risk of preterm birth <37 gestational weeks: 29.0% vs. 37.6% (RR 0.78 [95% CI 0.69 to 0.88]) (moderate certainty of evidence, four open trials). In addition, perinatal mortality may be reduced by cerclage. Pessary did not demonstrate any overall effect. ASA did not affect any outcome, but evidence was based on one underpowered study.Multifetal pregnancies: The effect of progesterone, cerclage, or pessary was minimal, if any. No study supported improved long-term outcome of the children.ConclusionProgesterone and probably also cerclage have a protective effect against preterm birth in asymptomatic women with a singleton pregnancy at risk of preterm birth. Further trials of ASA are needed. Prevention of preterm birth requires screening programs to identify women at risk of preterm birth.Systematic review registration[https://www.crd.york.ac.uk/prospero/], identifier [CRD42021234946].
| S-EPMC10015499 | biostudies-literature
Project description:Ultrasound-indicated cerclage (UIC) is recommended to prevent spontaneous preterm birth (sPTB) in women with a short cervix at mid-trimester and a history of PTB. We assessed the factors related to sPTB after UIC and determined the corresponding risks. This retrospective cohort study was conducted at a university hospital. UIC was performed between 15 and 26 weeks of gestation in women with a cervical length of <2.5 cm. Univariate and multivariate analyses were used to examine factors associated with sPTB after UIC. An earlier gestational age and shorter cervical length at UIC were associated with sPTB after UIC. While PTB history was not associated with an increased risk of sPTB, it did increase the risk of repeat cerclage after UIC. Higher levels of preoperative serum inflammatory markers and obesity significantly increased the risk of sPTB after UIC. These findings provide helpful guidance for patient counseling and management in predicting the delivery timing after UIC in women with a short cervix in the mid-trimester.
| S-EPMC10744759 | biostudies-literature
Project description:BackgroundPreterm birth is a major health problem and contributes to more than 50% of the overall perinatal mortality. Preterm birth has multiple risk factors including cervical incompetence and multiple pregnancy. Different management strategies have been tried to prevent preterm birth, including cervical cerclage. Cervical cerclage is an invasive technique that needs anaesthesia and may be associated with complications. Moreover, there is still controversy regarding the efficacy and the group of patients that could benefit from this operation. Cervical pessary has been tried as a simple, non-invasive alternative that might replace the above invasive cervical stitch operation to prevent preterm birth.ObjectivesTo evaluate the efficacy of cervical pessary for the prevention of preterm birth in women with risk factors for cervical incompetence.Search methodsWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 September 2012), Current Controlled Trials and the Australian New Zealand Clinical Trials Registry (1 September 2012).Selection criteriaWe selected all published and unpublished randomised clinical trials comparing the use of cervical pessary with cervical cerclage or expectant management for prevention of preterm birth. We did not include quasi-randomised trials. Cluster-randomised or cross-over trials were not eligible for inclusion.Data collection and analysisTwo review authors independently assessed trials for inclusion.Main resultsThe review included one randomised controlled trial. The study included 385 pregnant women with a short cervix of 25 mm or less who were between 18 to 22 weeks of pregnancy. The use of cervical pessary (192 women) was associated with a statistically significantly decrease in the incidence of spontaneous preterm birth less than 37 weeks' gestation compared with expectant management (22% versus 59 %; respectively, risk ratio (RR) 0.36, 95% confidence interval (CI) 0.27 to 0.49). Spontaneous preterm birth before 34 weeks was statistically significantly reduced in the pessary group (6% and 27% respectively, RR 0.24; 95% CI 0.13 to 0.43). Mean gestational age at delivery was 37.7 + 2 weeks in the pessary group and 34.9 + 4 weeks in the expectant group. Women in the pessary group used less tocolytics (RR 0.63; 95% CI 0.50 to 0.81) and corticosteroids (RR 0.66; 95% CI 0.54 to 0.81) than the expectant group. Vaginal discharge was more common in the pessary group (RR 2.18; 95% CI 1.87 to 2.54). Among the pessary group, 27 women needed pessary repositioning without removal and there was one case of pessary removal. Ninety-five per cent of women in the pessary group would recommend this intervention to other people. Neonatal paediatric care admission was reduced in the pessary group in comparison to the expectant group (RR 0.17; 95% CI 0.07 to 0.42).Authors' conclusionsThe review included only one well-designed randomised clinical trial that showed beneficial effect of cervical pessary in reducing preterm birth in women with a short cervix. There is a need for more trials in different settings (developed and developing countries), and with different risk factors including multiple pregnancy.
| S-EPMC6491132 | biostudies-literature
Project description:We aimed to develop, train, and validate machine learning models for predicting preterm birth (<37 weeks' gestation) in singleton pregnancies at different gestational intervals. Models were developed based on complete data from 22,603 singleton pregnancies from a prospective population-based cohort study that was conducted in 51 midwifery clinics and hospitals in Wenzhou City of China between 2014 and 2016. We applied Catboost, Random Forest, Stacked Model, Deep Neural Networks (DNN), and Support Vector Machine (SVM) algorithms, as well as logistic regression, to conduct feature selection and predictive modeling. Feature selection was implemented based on permutation-based feature importance lists derived from the machine learning models including all features, using a balanced training data set. To develop prediction models, the top 10%, 25%, and 50% most important predictive features were selected. Prediction models were developed with the training data set with 5-fold cross-validation for internal validation. Model performance was assessed using area under the receiver operating curve (AUC) values. The CatBoost-based prediction model after 26 weeks' gestation performed best with an AUC value of 0.70 (0.67, 0.73), accuracy of 0.81, sensitivity of 0.47, and specificity of 0.83. Number of antenatal care visits before 24 weeks' gestation, aspartate aminotransferase level at registration, symphysis fundal height, maternal weight, abdominal circumference, and blood pressure emerged as strong predictors after 26 completed weeks. The application of machine learning on pregnancy surveillance data is a promising approach to predict preterm birth and we identified several modifiable antenatal predictors.
| S-EPMC10941650 | biostudies-literature
Project description:IntroductionPreterm birth (PTB) is the leading cause of death in children under 5 years. Preventive therapies targeted towards women with risk factors such as a prior PTB or a short cervix reduce the rate of PTB. Cervical cerclage, vaginal progesterone and a combination of the two have been used with no consensus as to whether combined treatment is more effective than any single treatment alone. The objective of this review is to determine the efficacy of combined treatment compared with cerclage alone and combined treatment compared with progesterone alone.Methods and analysisStudies will be sourced from the electronic databases Medline (Ovid), EMBASE (Ovid), PsycINFO (Ovid), Scopus, CINAHL (EBSCOhost) and Cochrane Library (Wiley) and reference lists. We will not exclude any papers due to publication date. Randomised control trials (RCTs), non-RCTs and cohort studies assessing single therapy (either progesterone or cerclage) versus combined therapy in women with a singleton pregnancy will be included. Two independent reviewers will conduct study screening (at abstract and full-text level), data extraction and risk of bias assessment with disagreements resolved by an experienced researcher. Random or fixed effects models will be used depending on data heterogeneity and data will be presented as risk ratio for dichotomous data or mean difference for continuous data with a CI of 95% used for all outcomes.Ethics and disseminationNot applicable due to nature of the study type.Prospero registration numberCRD42020195975.
| S-EPMC8237739 | biostudies-literature
Project description:The objective was to characterise cervical leukocyte populations and inflammatory mediators associated with term and recurrent spontaneous preterm birth (SPTB) in pregnant women with a history of SPTB. A prospective observational study was undertaken on 120 women with a history of SPTB. A cytobrush was used to sample cells from the cervix at 12-25 weeks' gestation. Cells were enumerated and characterised by flow cytometry. Cytokines and chemokines were also measured. Participants were then grouped according to delivery at term (>36+6 weeks), late SPTB (34-36+6 weeks) or early SPTB (<34 weeks). Differences in leukocyte sub-populations, cytokine and chemokine levels were compared with outcome. Cervical leukocytes comprised up to 60% of the host-derived cells. Most of these (90-100%) were polymorphonuclear cells (PMN). Most of the remaining cells were mucosal macrophages expressing CD68 and CD103 in addition to markers shared with blood-borne monocytes. Failure to detect cervical macrophages in at least 250,000 cervical epithelial cells was a feature of women who experienced early SPTB (6 out of 6 cases, 95% CI 61-100%) compared with 34% (30 out of 88 cases, 95% CI 25-43%, P<0.001) of women delivering after 34 weeks. CCL2 (MCP-1) was also low in SPTB before 34 weeks and levels above 75 ng/g and/or the presence of macrophages increased the specificity for birth after 34 weeks from 66% to 82% (55 out of 67 cases, 95% CI 73-91%). Absence of cervical macrophages and low CCL2 may be features of pregnancies at risk of early SPTB.
| S-EPMC4764650 | biostudies-literature
Project description:BackgroundPreterm birth remains a major public health issue affecting 10% of all pregnancies and increases risks of neonatal morbidity and mortality. Approximately 50% to 60% of preterm births are spontaneous, resulting from preterm premature rupture of membranes or preterm labor. The pathogenesis of spontaneous preterm birth is incompletely understood, and prediction of preterm birth remains elusive. Accurate prediction of preterm birth would reduce infant morbidity and mortality through targeted patient referral to hospitals equipped to care for preterm infants. Two previous studies have analyzed cervical microRNAs in association with spontaneous preterm birth and the length of gestation, but the extent to which microRNAs serve as predictive biomarkers remains unknown.ObjectiveThis study aimed to examine associations between cervical microRNA expression and spontaneous preterm birth, with the specific goal of identifying a subset of microRNAs that predict spontaneous preterm birth.Study designWe performed a prospective, nested, case-control study of 25 cases with spontaneous preterm birth and 49 term controls. Controls were matched to cases in a 2:1 ratio on the basis of age, parity, and self-identified race. Cervical swabs were collected at a mean gestational age of 17.1 (4.8) weeks of gestation, and microRNAs were analyzed using a quantitative polymerase chain reaction array. Normalized microRNA expression was compared between cases and controls, and a false discovery rate of 0.2 was applied to account for multiple comparisons. Histopathologic analysis of slides of cervical swab samples was performed to quantify leukocyte burden for adjustment in conditional regression models. We explored the use of Relief-based unsupervised identification of top microRNAs and support vector machines to predict spontaneous preterm birth. We performed microRNA enrichment analysis to explore potential biologic targets and pathways in which up-regulated microRNAs might be involved.ResultsOf the 754 microRNAs on the polymerase chain reaction array, 346 were detected in ≥75% of participants' cervical swabs. Average cervical microRNA expression was significantly higher in cases of spontaneous preterm birth than in controls (P=.01). There were 95 significantly up-regulated individual microRNAs (>2-fold change) in cases of subsequent spontaneous preterm birth compared with term controls (P<.05; q<0.2). Notably, miR-143, miR-30e-3p, and miR-199b were all significantly up-regulated, which is consistent with the 1 previous study of cervical microRNA and spontaneous preterm birth. A Relief-based, novel variable (feature) selection machine learning approach had low-to-moderate prediction accuracy, with an area under the receiver operating curve of 0.71. Enrichment analysis revealed that identified microRNAs may modulate inflammatory cell signaling.ConclusionIn this prospective nested case-control study of cervical microRNA expression and spontaneous preterm birth, we identified a global increase in microRNA expression and up-regulation of 95 distinct microRNAs in association with subsequent spontaneous preterm birth. Larger and more diverse studies are required to determine the ability of microRNAs to accurately predict spontaneous preterm birth, and mechanistic work to facilitate development of novel therapeutic interventions to prevent spontaneous preterm birth is warranted.
| S-EPMC9772144 | biostudies-literature