Dataset Information

The Feasibility of Cervical Elastography in Predicting Preterm Delivery in Singleton Pregnancy with Short Cervix Following Progesterone Treatment.

ABSTRACT: Previous studies demonstrated an association between cervical strain and risk of spontaneous preterm delivery (sPTD). The present study aimed to assess the efficacy of elastography in predicting sPTD at <32 weeks of gestation in women with singleton pregnancies receiving progesterone for short cervix (≤2.5 cm) diagnosed between 16 and 28 weeks of gestation Among 115 participants eligible for analysis, nine had sPTD at <32 weeks. Preprogesterone (PP0) mean internal os strain (IOS), elasticity contrast index (ECI), hardness ratio (HR), one-week postprogesterone (PP1) IOS, mean external os strain (EOS), ECI, and HR were significantly different between groups. Higher PP0 IOS, PP1 IOS, and PP1 EOS were associated with a 2.92, 4.39 and 3.65-fold increase in the risk of sPTD at <32 weeks, respectively (adjusted for cervical length (CL) at diagnosis; p = 0.04, 0.012 and 0.026, respectively). A combination of CL at diagnosis, PP0 IOS and PP1 EOS showed a significantly higher area under the receiver operating characteristic curve (0.858) than that of CL alone (p = 0.041). In women with singleton pregnancies receiving progesterone for short cervix, cervical elastography performed before and one week after progesterone treatment may be useful in predicting sPTD at <32 weeks of gestation.

SUBMITTER: Jung YJ

PROVIDER: S-EPMC7922916 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The Feasibility of Cervical Elastography in Predicting Preterm Delivery in Singleton Pregnancy with Short Cervix Following Progesterone Treatment.

Jung Yun Ji YJ Kwon Hayan H Shin Jeongeun J Park Yejin Y Heo Seok-Jae SJ Park Hyun Soo HS Oh Soo-Young SY Sung Ji-Hee JH Seol Hyun-Joo HJ Kim Hyun Mi HM Seong Won Joon WJ Hwang Han Sung HS Jung Inkyung I Kwon Ja-Young JY

International journal of environmental research and public health 20210219 4

Previous studies demonstrated an association between cervical strain and risk of spontaneous preterm delivery (sPTD). The present study aimed to assess the efficacy of elastography in predicting sPTD at <32 weeks of gestation in women with singleton pregnancies receiving progesterone for short cervix (≤2.5 cm) diagnosed between 16 and 28 weeks of gestation Among 115 participants eligible for analysis, nine had sPTD at <32 weeks. Preprogesterone (PP0) mean internal os strain (IOS), elasticity con ...[more]

PMID: 33669696

Similar Datasets

Project description:BackgroundLimited studies have used cervical shear wave elastography (SWE) as a tool to investigate the predictive effect of cervical changes on preterm delivery (PTD) in twin pregnancy. This study is aimed to predict the risk of PTD by cervical SWE in dichorionic diamniotic (DCDA) twin pregnancy.MethodsA total of 138 women with dichorionic diamniotic (DCDA) twins were included in this prospective study. The mean SWE value of the cervix was obtained from the inner, middle and outer regions of the anterior and posterior cervical lips using a transvaginal ultrasound transducer and measured consecutively across three different gestations (20-23+ 6 weeks, 24-27+ 6 weeks, and 28-32 weeks). Follow-up was performed on all subjects, and we compared the mean SWE value between the PTD and term delivery (TD) groups.ResultsA total of 1656 cervical mean SWE data were collected for analysis. Among the 138 twin pregnant women, only 92 women completed the three elastography examinations; PTD occurred in 58.7% (54/92), and TD in 41.3% (38/92). The mean (SD) maternal age was 33.1 ± 4.1 years, and the mean (SD) body mass index was 21.1 ± 2.6 kg/m2. As gestational age increased, the mean SWE value of each part of the cervix decreased. The cervical mean SWE value was lower in the preterm group than in the term group in all three gestations, except for the anterior cervical lip at 28-32 weeks. Receiver operating characteristics (ROC) curves showed the sensitivity of mean SWE value of the anterior cervical lip was 83.3% (95% CI, 70.7-92.1) with a specificity of 57.9% (95% CI, 40.8-73.7) for predicting PTD at a cutoff value of 7.94 kPa. The positive likelihood ratio (LR+) was 1.67 (95% CI, 1.19-2.34), and the negative likelihood ratio (LR-) was 0.33 (95% CI, 0.17-0.64).ConclusionsThere is a significant negative correlation between cervical stiffness and gestational age in DCDA twin pregnancy. SWE is a potential tool for assessing cervical stiffness and predicting PTD in DCDA twin pregnancy.

Project description:ObjectiveTo investigate whether the classification of a previous spontaneous preterm birth (sPTB) as preterm labor (PTL) with intact membranes (IM) or as preterm prelabor rupture of membranes (PPROM) impacts the efficacy of cervical pessary or vaginal progesterone for prevention of sPTB in pregnant women with short cervix on transvaginal ultrasound.MethodsThis was a retrospective cohort study of asymptomatic high-risk singleton pregnancies with a short cervix and history of sPTB, treated using Arabin pessary or vaginal progesterone for primary PTB prevention, conducted at four European hospitals. A log-rank test on Kaplan-Meier curves was used to assess the difference in performance of pessary and progesterone, according to history of PTL-IM or PPROM. Linear regression analysis was used to evaluate significant predictors of gestational age at delivery.ResultsBetween 2008 and 2015, 170 women were treated with a pessary and 88 with vaginal progesterone. In women treated with a pessary, rate of sPTB < 34 weeks was 16% in those with a history of PTL-IM and 55% in those with a history of PPROM. In women treated with progesterone, rate of sPTB < 34 weeks was 13% in those with a history of PTL-IM and 21% in those with a history of PPROM. Treatment with a pessary resulted in earlier delivery in women with previous PPROM than in any other subgroup (P < 0.0001). Linear regression analysis showed a clear effect of PPROM history (P < 0.0001), combination of PPROM history and treatment (P = 0.0003) and cervical length (P = 0.0004) on gestational age at birth.ConclusionsCervical pessary may be a less efficacious treatment option for women with previous PPROM; however, these results require prospective validation before change in practice is recommended. Phenotype of previous preterm birth may be an important risk predictor and treatment effect modifier; this information should be reported in future clinical trials. © 2018 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of the International Society of Ultrasound in Obstetrics and Gynecology.

Project description:BackgroundSpontaneous preterm birth (sPTB) stands as a leading cause of neonatal mortality. Consequently, preventing sPTB has emerged as a paramount concern in healthcare. Therefore, our study aimed to develop a nomogram, encompassing patient characteristics and cervical elastography, to predict sPTB in singleton pregnancies. Specifically, we targeted those with a short cervix length (CL), no history of sPTB, and who were receiving vaginal progesterone therapy.MethodsA total of 568 patients were included in this study. Data from 392 patients, collected between January 2016 and October 2019, constituted the training cohort. Meanwhile, records from 176 patients, spanning November 2019 to January 2022, formed the validation cohort. Following the univariate logistic regression analysis, variables exhibiting a P-value less than 0.05 were integrated into a multivariable logistic regression analysis. The primary objective of this subsequent analysis was to identify the independent predictors linked to sPTB in the training cohort. Next, we formulated a nomogram utilizing the identified independent predictors. This tool was designed to estimate the likelihood of sPTB in singleton pregnancies, particularly those with a short CL, devoid of any sPTB history, and undergoing vaginal progesterone therapy. The C-index, Hosmer-Lemeshow (HL) test, calibration curves, decision curve analysis (DCA), and receiver operating characteristic (ROC) were used to validate the performance of the nomogram.ResultsUpon finalizing the univariate analysis, we progressed to a multivariable analysis, integrating 8 variables with P < 0.05 from the univariate analysis. The multivariable analysis identified 7 independent risk factors: maternal age (OR = 1.072; P < 0.001), cervical length (OR = 0.854; P < 0.001), uterine curettage (OR = 7.208; P < 0.001), GDM (OR = 3.570; P = 0.006), HDP (OR = 4.661; P = 0.003), C-reactive protein (OR = 1.138; P < 0.001), and strain of AI (OR = 7.985; P < 0.001). The nomogram, tailored for sPTB prediction, was grounded on these 7 independent predictors. In predicting sPTB, the C-indices manifested as 0.873 (95% CI, 0.827-0.918) for the training cohort and 0.916 (95%CI, 0.870-0.962) for the validation cohorts, underscoring a good discrimination of the model. Additionally, the ROC curves served to evaluate the discrimination of nomogram model across both cohorts. Calibration curves were delineated, revealing no statistically significant differences in both the training (χ2 = 5.355; P = 0.719) and validation (χ2 = 2.708; P = 0.951) cohorts as evidenced by the HL tests. Furthermore, the DCA underscored the model's excellence as a predictive tool for sPTB.ConclusionsBy amalgamating patient characteristics and cervical elastography data from the second trimester, the nomogram emerged as a visually intuitive and dependable tool for predicting sPTB. Its relevance was particularly pronounced for singleton pregnancies characterized by a short CL, an absence of prior sPTB incidents, and those receiving vaginal progesterone therapy.

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.

Project description:Objective: To evaluate the effectiveness of vaginal progesterone in preventing preterm birth in women with a singleton gestation and short cervical length and to determine which of the two formulations, micronized progesterone vaginal capsule versus vaginal gel containing micronized progesterone, is more effective for preventing preterm birth. Data sources: A systematic search was performed in the following databases: EMBASE, PubMed (MEDLINE), The Cochrane Library, and the Clinical Trials Registry (clinicaltrials.gov). Study eligibility criteria: Randomized controlled trials (RCTs), prospective and retrospective observational studies were included. We searched for progesterone administration to prevent preterm birth in asymptomatic women with a shortened cervix (<25 mm) measured by ultrasound in the second trimester of singleton pregnancy. Study appraisal and synthesis methods: Assessments of the risk of bias of RCTs were performed by applying the Cochrane Collaboration's Risk of Bias Tool; non-randomized control trials were evaluated with the Newcastle-Ottawa Scale (NOS). The primary outcome was preterm birth ≤33 weeks of gestation. Pooled relative risks (RR) and 95% CI's were calculated for dichotomous outcomes. Heterogeneity of treatment effect was assessed with the I2 statistic. We pooled results of the primary outcome for individual studies using a random-effect model. We then performed a network meta-analysis to pool indirect comparisons between the two formulations (gel vs capsule). This analysis was performed using the network meta-analysis package within the R environment. Results: Five studies met the inclusion criteria (4 RCTs, one cohort study) including 1,048 women. The meta-analysis demonstrated that vaginal micronized progesterone significantly reduces preterm birth risk, Risk Ratio = 0.63; 95% CI, 0.48-0.82; p = 0.0006; with no heterogeneity between the studies: I 2 = 0%. In the network meta-analysis, no significant difference was demonstrated (OR = 0.85; 95% CI, 0.43-1.69) between the effect of the two formulations of vaginal micronized progesterone (vaginal gel versus vaginal capsules) on the risk of PTB. Conclusion: Vaginal progesterone is associated with a decreased risk of premature birth in women with a shortened cervix in the second trimester of pregnancy. No differences were found between vaginal micronized progesterone in gel or capsule formulations. Systematic Review Registration: PROSPERO, identifier CRD42020165198.

Project description:ObjectiveTo evaluate the long-term outcomes of children born to women with a short cervix and otherwise low risk for preterm birth, after antenatal exposure to vaginal progesterone vs placebo.MethodsThis was a follow-up study of the Triple P trial, which randomized 80 low-risk women with a short cervix (≤ 30 mm) at 18-22 weeks' gestation to progesterone (n = 41) or placebo (n = 39). At 2 years of corrected age, children were invited for a neurodevelopmental assessment, using the Bayley Scales of Infant and Toddler Development, third edition (BSID-III), and a neurological and physical examination by an assessor blinded to the allocated treatment. Parents filled out the Ages and Stages Questionnaire, the Child Behavior Checklist (CBCL) and a general-health questionnaire. The main outcome of interest was mean BSID-III cognitive and motor scores. Additionally, a composite score of mortality and abnormal developmental outcome, including BSID-III ≤-1 SD, CBCL score in the clinical range and/or parental reported physical problems (at least two operations or at least two hospital admissions in the previous 2 years), was evaluated. Our sample size, dictated by the original sample of the Triple P trial, provided 80% power to detect a mean difference (MD) of 15 points (1 SD) between groups for the BSID-III tests.ResultsOf the 80 children born to the randomized women, one in the progesterone group and two in the placebo group died in the neonatal period. Follow-up data were obtained for 59/77 (77%) children and BSID-III outcomes in 57 children (n = 28 in the progesterone group and n = 29 in the placebo group) born at a median gestational age of 38 + 6 weeks (interquartile range (IQR), 37 + 3 to 40 + 1 weeks) with a median birth weight of 3240 g (IQR, 2785-3620 g). In the progesterone vs placebo groups, mean BSID-III cognitive development scores were 101.6 vs 105.0 (MD, -3.4 (95% CI, -9.3 to 2.6); P = 0.29) while mean motor scores were 102.4 vs 107.3 (MD, -4.9 (95% CI, -11.2 to 1.4); P = 0.13). No differences were seen between the two groups in physical (including genital and neurological examination), behavioral and health-related outcomes.ConclusionIn this sample of children born to low-risk women with a short cervix at screening, no relevant differences in neurodevelopmental, behavioral, health-related and physical outcomes were found between offspring exposed to vaginal progesterone and those exposed to placebo. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Project description:ImportanceA short cervix as assessed by transvaginal ultrasound is an established risk factor for preterm birth. Study findings for a cervical pessary to prevent preterm delivery in singleton pregnancies with transvaginal ultrasound evidence of a short cervix have been conflicting.ObjectiveTo determine if cervical pessary placement decreases the risk of preterm birth or fetal death prior to 37 weeks among individuals with a short cervix.Design, setting, and participantsWe performed a multicenter, randomized, unmasked trial comparing a cervical pessary vs usual care from February 2017 through November 5, 2021, at 12 centers in the US. Study participants were nonlaboring individuals with a singleton pregnancy and a transvaginal ultrasound cervical length of 20 mm or less at gestations of 16 weeks 0 days through 23 weeks 6 days. Individuals with a prior spontaneous preterm birth were excluded.InterventionsParticipants were randomized 1:1 to receive either a cervical pessary placed by a trained clinician (n = 280) or usual care (n = 264). Use of vaginal progesterone was at the discretion of treating clinicians.Main outcome and measuresThe primary outcome was delivery or fetal death prior to 37 weeks.ResultsA total of 544 participants (64%) of a planned sample size of 850 were enrolled in the study (mean age, 29.5 years [SD, 6 years]). Following the third interim analysis, study recruitment was stopped due to concern for fetal or neonatal/infant death as well as for futility. Baseline characteristics were balanced between participants randomized to pessary and those randomized to usual care; 98.9% received vaginal progesterone. In an as-randomized analysis, the primary outcome occurred in 127 participants (45.5%) randomized to pessary and 127 (45.6%) randomized to usual care (relative risk, 1.00; 95% CI, 0.83-1.20). Fetal or neonatal/infant death occurred in 13.3% of those randomized to receive a pessary and in 6.8% of those randomized to receive usual care (relative risk, 1.94; 95% CI, 1.13-3.32).Conclusions and relevanceCervical pessary in nonlaboring individuals with a singleton gestation and with a cervical length of 20 mm or less did not decrease the risk of preterm birth and was associated with a higher rate of fetal or neonatal/infant mortality.Trial registrationClinicalTrials.gov Identifier: NCT02901626.

Dataset Information

The Feasibility of Cervical Elastography in Predicting Preterm Delivery in Singleton Pregnancy with Short Cervix Following Progesterone Treatment.

Publications

The Feasibility of Cervical Elastography in Predicting Preterm Delivery in Singleton Pregnancy with Short Cervix Following Progesterone Treatment.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets