Cervical Pessary for Prevention of Preterm Birth in Individuals With a Short Cervix: The TOPS Randomized Clinical Trial.

Importance: A 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. Objective: To 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 Participants: We 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. Interventions: Participants 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 Measures: The primary outcome was delivery or fetal death prior to 37 weeks. Results: A 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 Relevance: Cervical 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 Registration: ClinicalTrials.gov Identifier: NCT02901626.

Advancements in the Application of Ultrasound Elastography in the Cervix.

Ultrasound elastography is a modern imaging technique that has developed rapidly in recent years. It enables objective measurement of tissue stiffness, a physical property intuitive to the human sense of touch. This novel technology has become a hotspot and plays a major role in scientific research and academic practice. Presently, ultrasound elastography has been used in the identification of benign and malignant tumors in superficial organs, such as breast and thyroid, providing clinically accurate diagnosis and treatment. The method has also been widely used for the liver, kidney, prostate, lymph nodes, blood vessels, skin and muscle system. In the application of cervical lesions, ultrasound elastography can distinguish normal cervix from abnormal cervix and differentiate benign from malignant lesions. It can significantly improve the diagnostic specificity for cervical cancer and is also useful for assessing infiltration depth and stage of cervical cancer, as well as predicting chemoradiotherapy treatment response. For cervical evaluation during pregnancy, ultrasound elastography is useful for assessing cervical softening and predicting premature delivery and outcome of induced labor. This article reviews the principles of ultrasound elastography as well as the current status and limitations in its application for cervical lesions and the cervix during pregnancy.

Ultrasonographic features of uterine cervical lesions.

Currently, ultrasound (US) is a valuable imaging tool for the initial assessment and evaluation of the female genital organs, uterus, and adnexa. However, it is easy to overlook the uterine cervix while conducting a pelvic US. Uterine cervical lesions may range from benign to malignant in nature. Therefore, meticulous examination with US may play a key role in assessing uterine cervical lesions. Although there is substantial overlap in the US findings across various uterine cervical lesions, some US features, in tandem with clinical characteristics, may suggest a specific diagnosis. Familiarity with the clinical settings and US characteristics of different uterine cervical lesions can support prompt and accurate diagnosis of suspicious lesions. This review article aims to describe the features of US and possible values for distinction of these lesions in the uterine cervix.

Accuracy of transvaginal sonoelastography for differential diagnosis between malignant and benign cervical lesions: A systematic review and meta-analysis.

BACKGROUND: To evaluate the performance of transvaginal sonoelastography (TVSE) for differential diagnosis between malignant and benign cervical lesions using a meta-analysis. METHODS: An independent literature search was conducted on the English medical database, including PubMed, Embase and Medline, Cochrane Library, Web of Science, and OVID. The diagnostic accuracy of TVSE was compared with that of histopathology, which is the gold reference standard for diagnosis. The accuracy of TVSE was assessed by calculating the pooled sensitivity, specificity, diagnostic odds ratio, and area under the curve (AUC). The imaging mechanisms, assessment methods, and QUADAS scores were assessed with a meta-regression analysis. A Deeks funnel plot was performed for evaluating publication bias. RESULTS: Six eligible studies reported a total sample of 615 cervical lesions (415 cancers, 200 benign lesions). TVSE showed a pooled diagnostic odds ratio of 21.42 (95% CI 13.65-33.61), sensitivity of 0.87 (95% CI 0.84-0.90), specificity of 0.79 (95% CI 0.72-0.84), and an AUC of 0.892 (Q* = 0.822). The results of the meta-regression analysis showed that the imaging mechanism (P = .253), the assessment method (P = .279), or QUADAS score (P = .205) did not affect the study heterogeneity. CONCLUSION: TVSE has a relatively high and satisfactory value for differential diagnosis between malignant and benign cervical lesions. The diagnostic performance of strain elastography and shear wave elastography were similar and good. However, to accommodate heterogeneity and publication bias, high-quality studies are required to further comparative effectiveness analyses to verify the efficacy of ultrasound detection.

Impact of additional risk factors on the incidence of preterm delivery among pregnant women diagnosed with short cervix.

OBJECTIVE: Additional risk factors for preterm delivery in pregnant women with cervical shortening are not fully understood; however, mid-trimester cervical shortening is accepted as a risk factor for preterm delivery. This study aimed to identify risk factors associated with subsequent preterm delivery among patients with short cervix detected after late mid-trimester. MATERIALS AND METHODS: This was a retrospective study of medical data from a single perinatal tertiary facility. We identified 134 asymptomatic women with singleton pregnancies where cervical shortening (≤25 mm) was detected during routine universal screening at 22-33 weeks. Statistical analyses were conducted to identify causal relationships between the incidence of preterm delivery and known risk factors for preterm delivery. RESULTS: Incidence of preterm delivery was 27.6% (37/134) and preterm premature rupture of membrane was preceded in 46.0% (17/37) of the women with preterm delivery. Using logistic regression analysis, we identified uterine contractions [aOR 4.25, 95% confidence intervals (CI):1.68-12.1] and increased C-reactive protein (CRP) and increased white blood cell (WBC) in blood test (CRP: aOR 3.45, 95% CI:1.50-9.71; WBC: aOR 1.28, 95% CI: 1.08-1.55) as risk factors which significantly increased the risk of preterm delivery among women diagnosed with short cervix. Preterm delivery occurred in 91% of women positive for both uterine contractions and CRP >0.5 mg/dl. CONCLUSIONS: Uterine contraction and elevated CRP were additional risk factors for preterm delivery among women with short cervix. These results might be clinically useful to evaluate subsequent risk for preterm delivery in asymptomatic pregnant women presenting with short cervix in mid-pregnancy.

A large nabothian cyst causing chronic urinary retention: A case report.

RATIONALE: Nabothian cysts are mucus-filled cervical cysts that are usually asymptomatic unless they become very large. Chronic urinary retention is the persistent inability to empty the bladder despite maintaining an ability to urinate. Chronic urinary retention caused by a large, deep nabothian cyst has not been reported previously. PATIENT CONCERNS: A 46-year-old woman presented with chronic urinary retention and a cervical cyst that gradually increased in size. DIAGNOSIS: Based on histopathological evidence, our patient was diagnosed with a nabothian cyst. INTERVENTIONS: A hysterectomy was performed. OUTCOMES: The urinary symptoms of the patient resolved after she performed clean, intermittent self-catheterizations for 5 days after the operation. She was discharged on postoperative day 6. LESSONS: Large nabothian cysts are rare but may account for some unusual symptoms including unexplained urinary difficulties in women. We recommend treating symptomatic nabothian cysts with local cystectomies or hysterectomies.

Transvaginal Real-time Shear Wave Elastography in the Diagnosis of Cervical Disease.

OBJECTIVES: To explore the value of shear wave elastography in the diagnosis of cervical disease. METHODS: This work was a retrospective analysis of 246 cases of cervical lesions confirmed by transvaginal conventional ultrasound, shear wave elastography, and a cytologic test. The lesions were divided into 2 groups according to the final pathologic results: a malignant cervical group and a benign cervical group. In addition, the normal cervix was set as the control group. RESULTS: The maximum and mean shear wave velocity values ± SD were 5.24 ± 1.11 and 4.91 ± 1.12 m/s for the malignant cervical group, 3.93 ± 0.39 and 3.53 ± 0.52 m/s for the benign cervical group, and 3.27 ± 0.31 and 2.86 ± 0.23 m/s for the normal cervix, respectively. The areas under the receiver operating characteristic curves for the maximum and mean shear wave velocity in the differential diagnosis of a normal cervix and benign cervical tumors were 0.909 and 0.878 (both P < .001), whereas in the differential diagnosis of benign and malignant cervical tumors, they were 0.909 and 0.895 (both P < .001). CONCLUSIONS: Shear wave elastography can quantitatively analyze the elastic characteristics of cervical diseases, help differentially diagnose cervical diseases, accurately determine the extent of tumor invasion, and improve effective clinical staging and treatment.

Computer-Aided Diagnosis of Label-Free 3-D Optical Coherence Microscopy Images of Human Cervical Tissue.

OBJECTIVE: Ultrahigh-resolution optical coherence microscopy (OCM) has recently demonstrated its potential for accurate diagnosis of human cervical diseases. One major challenge for clinical adoption, however, is the steep learning curve clinicians need to overcome to interpret OCM images. Developing an intelligent technique for computer-aided diagnosis (CADx) to accurately interpret OCM images will facilitate clinical adoption of the technology and improve patient care. METHODS: 497 high-resolution three-dimensional (3-D) OCM volumes (600 cross-sectional images each) were collected from 159 ex vivo specimens of 92 female patients. OCM image features were extracted using a convolutional neural network (CNN) model, concatenated with patient information [e.g., age and human papillomavirus (HPV) results], and classified using a support vector machine classifier. Ten-fold cross-validations were utilized to test the performance of the CADx method in a five-class classification task and a binary classification task. RESULTS: An 88.3 ± 4.9% classification accuracy was achieved for five fine-grained classes of cervical tissue, namely normal, ectropion, low-grade and high-grade squamous intraepithelial lesions (LSIL and HSIL), and cancer. In the binary classification task [low-risk (normal, ectropion, and LSIL) versus high-risk (HSIL and cancer)], the CADx method achieved an area-under-the-curve value of 0.959 with an 86.7 ± 11.4% sensitivity and 93.5 ± 3.8% specificity. CONCLUSION: The proposed deep-learning-based CADx method outperformed four human experts. It was also able to identify morphological characteristics in OCM images that were consistent with histopathological interpretations. SIGNIFICANCE: Label-free OCM imaging, combined with deep-learning-based CADx methods, holds a great promise to be used in clinical settings for the effective screening and diagnosis of cervical diseases.

Conservative Management of Huge Symptomatic Endocervical Polyp in Pregnancy: A Case Report.

Cervical polyp is very rare in pregnancy, usually asymptomatic and small. There are several reports of different sizes of cervical polyp in pregnancy but, huge cervical polyp causing funnelling and shortening of cervical length was first reported in 2014. It was managed by polypectomy causing cervical length to return to normal value. We present the second case report in literature of a huge endocervical polyp in pregnancy that caused funnelling and shortening of cervical length. Unlike the earlier report this patient presented with preterm contractions and antepartum haemorrhage (APH). She was managed conservatively by polypectomy at 38 weeks of gestation without complications. This is the first case report in the literature of a huge symptomatic endocervical polyp in pregnancy presenting with preterm contractions and APH that was conservatively managed. The role of such management has been emphasized.

Plicae palmatae in neonates: tumor mimic on sonography.

Plicae palmatae are uterine cervical folds that can be misdiagnosed as a uterine septum on magnetic resonance imaging (MRI). Previous studies in the literature generally tend to include only adults and are limited to MRI findings. Here, we present the case of a 6-day-old girl with a tumorous lesion in her uterine isthmus on sonography. Although we considered uterine tumor as a differential diagnosis, the smooth surface and continuity with a cervical fold on the caudal side suggested that the lesion was, in fact, the tip of plicae palmatae. MRI was subsequently performed, and no restricted diffusion was found, which was useful in ruling out a malignant tumor. Our case highlights that plicae palmatae in neonates can mimic a tumor on sonography. Meticulous observation of a continuity with a cervical fold is essential for correct diagnosis.

Cervical varices: An unusual source of first-trimester hemorrhage.

Endocervical varices are a rare cause of obstetrical hemorrhage. Usually presenting in the second and third trimesters, bleeding varices often require pregnancy termination or indicated preterm birth via cesarean delivery. Our patient experienced variceal hemorrhage at 12 weeks' gestation in a dichorionic twin pregnancy conceived through in vitro fertilization. A low-lying placenta resolved at 19 weeks followed by variceal regression at 22 weeks' gestation. Endocervical varices causing first-trimester hemorrhage may regress with resolution of a coexisting low placental implantation, permitting planned vaginal delivery, despite progressive hemodynamic changes of pregnancy. © 2017 Wiley Periodicals, Inc. J Clin Ultrasound 46:218-221, 2018.

Cervical length in adolescents versus adults.

PURPOSE: Two of the known risk factors for spontaneous preterm birth (sPTB) are short cervical length (CL) ≤ 25 mm and adolescence (≤19 years). Our objective was to evaluate whether adolescent women have a higher incidence of short CL compared to their 20-24 year old counterparts. MATERIALS AND METHODS: Retrospective cohort of nulliparous singleton gestations undergoing universal second trimester transvaginal ultrasound (TVU) CL screening between January 2012 and June 2013. Adolescent women ≤19 years of age were compared to women 20-24 years of age. Primary outcomes were mean CL and incidence of CL ≤25 mm. Secondary outcomes were incidence of PTB <37 weeks, delivery mode, birth weight, and NICU admission. RESULTS: One hundred and five adolescents and 236 women 20-24 years underwent TVU CL screening. There was no difference in mean CL (40.6 mm vs. 40.6 mm, p = 0.51) or incidence of CL ≤25 mm (1.0% vs. 1.7%; OR 0.56 [0.06-5.1]). After controlling for maternal differences, there still was no significant correlation between maternal age and CL. There was no significant difference in PTB, birth weight, or NICU admission between the groups. CL measurements did not significantly differ across all maternal ages (14-42 years). CONCLUSIONS: There is no difference in mean CL or incidence of CL ≤25 mm among adolescents compared to women 20-24 years.

Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length: the Quadruple P randomised controlled trial.

BACKGROUND: Preterm birth is in quantity and in severity the most important topic in obstetric care in the developed world. Progestogens and cervical pessaries have been studied as potential preventive treatments with conflicting results. So far, no study has compared both treatments. METHODS/DESIGN: The Quadruple P study aims to compare the efficacy of vaginal progesterone and cervical pessary in the prevention of adverse perinatal outcome associated with preterm birth in asymptomatic women with a short cervix, in singleton and multiple pregnancies separately. It is a nationwide open-label multicentre randomized clinical trial (RCT) with a superiority design and will be accompanied by an economic analysis. Pregnant women undergoing the routine anomaly scan will be offered cervical length measurement between 18 and 22 weeks in a singleton and at 16-22 weeks in a multiple pregnancy. Women with a short cervix, defined as less than, or equal to 35 mm in a singleton and less than 38 mm in a multiple pregnancy, will be invited to participate in the study. Eligible women will be randomly allocated to receive either progesterone or a cervical pessary. Following randomization, the silicone cervical pessary will be placed during vaginal examination or 200 mg progesterone capsules will be daily self-administered vaginally. Both interventions will be continued until 36 weeks gestation or until delivery, whichever comes first. Primary outcome will be composite adverse perinatal outcome of perinatal mortality and perinatal morbidity including bronchopulmonary dysplasia, intraventricular haemorrhage grade III and IV, periventricular leukomalacia higher than grade I, necrotizing enterocolitis higher than stage I, Retinopathy of prematurity (ROP) or culture proven sepsis. These outcomes will be measured up until 10 weeks after the expected due date. Secondary outcomes will be, among others, time to delivery, preterm birth rate before 28, 32, 34 and 37 weeks, admission to neonatal intensive care unit, maternal morbidity, maternal admission days for threatened preterm labour and costs. DISCUSSION: This trial will provide evidence on whether vaginal progesterone or a cervical pessary is more effective in decreasing adverse perinatal outcome in both singletons and multiples. TRIAL REGISTRATION: Trial registration number: NTR 4414 . Date of registration January 29th 2014.

Sonovaginography: A Useful Technique in the Assessment of the Lower Genital Tract.

Conventional sonographic evaluation of the cervix and vagina is compromised by inattention, poor subject contrast, and obscuring artifacts. We describe a technique involving distention of the vaginal canal and fornices with ultrasound gel, providing an acoustic window for improved definition of the cervix and vagina. This exam is usually performed in concert with transvaginal sonography, but a transabdominal or transperineal approach may be more useful in selected scenarios. A wide variety of formerly sonographically inconspicuous conditions are demonstrable with this technique, many of which were undetected or inadequately characterized on the physical exam. Cervical polyps were the most commonly seen abnormality.