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Objective: To study and compare the clinical effects of cervical pessary and progesterone for preventing preterm birth in singleton pregnant women with a short cervical length (CL). Methods: This study was a prospective cohort study. A total of 148 pregnant women with CL≤25 mm, as determined by ultrasound examination performed before 28 weeks of pregnancy, were included in the study. All subjects were admitted to West China Second Hospital, Sichuan University between August 2020 and December 2022. According to their treatment plans, the pregnant women were divided into a cervical pessary group (n=55) and a progesterone group (n=93). Spontaneous preterm birth before 37 weeks of pregnancy was defined as the main outcome index. Preterm birth (abortion) or spontaneous preterm birth (abortion) before 37, 34, 32, 30, and 28 weeks of pregnancy, mean extended gestational age, neonatal morbidity, and neonatal mortality were the secondary outcome indicators. The pregnancy outcomes and the neonatal outcomes of the two groups were compared and statistically analyzed. Results: There was no statistically significant difference in the incidence of preterm birth (including iatrogenic preterm birth, spontaneous preterm birth, and abortion) before 37, 34, 32, 30, and 28 weeks between the cervical pessary group and the progesterone group. When iatrogenic preterm birth was excluded, the incidence of spontaneous preterm birth before 37 weeks was lower in the cervical pessary group (23.6%) than that in the progesterone group (41.9%), with the difference between the two groups being statistically significant (P=0.024). There was no statistically significant difference in the incidence of spontaneous preterm birth (including miscarriage) before 34, 32, 30, and 28 weeks. There was no statistically significant difference in the incidence of neonatal morbidity, the rate of transfer to the neonatal care unit after birth, and the neonatal mortality rate between the two groups. Multivariate logistic analysis showed that treatment with cervical pessary was a protective factor for spontaneous preterm birth before 37 weeks compared to progesterone therapy. Conclusion: Using cervical pessary to prevent spontaneous preterm birth in singleton pregnant women with a short cervical length in the second trimester can significantly reduce the incidence of spontaneous preterm birth before 37 weeks.

SMFM Consult Series #70: Management of short cervix in individuals without a history of spontaneous preterm birth.

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).

Risk factors of early spontaneous preterm birth despite carrying a cervical pessary in singleton pregnancies with a short cervix: Development of a risk prediction model.

Introduction: We aimed to identify the incidence and risk factors of spontaneous preterm birth in pessary carriers with singleton pregnancies and a short cervix in the mid-trimester of pregnancy. Material and Methods: Patient data were obtained from the PECEP Trial. We analyzed singleton pregnancies in pessary carriers with a short cervix (≤25 mm) between 18 and 22 gestational weeks. Demographics and obstetric history were compared to identify risk factors for spontaneous preterm birth < 34 gestational weeks. Each demographic and obstetric variable was compared between spontaneous preterm birth < 34 and ≥ 34 weeks of gestation.Regression analysis was used to identify risk factors. A risk score model was generated using the odds ratio for significant factors. The risk score model and spontaneous preterm birth risk were assessed using the receiver operating characteristic curve. Perinatal outcomes were compared by risk score. Results: Among 190 pregnant individuals, 12 (6.3%) had spontaneous preterm birth < 34 gestational weeks. In the bivariate analysis, statistically significant differences between those with and without spontaneous preterm birth were only observed for mean cervical length at diagnosis and mean cervical length after pessary placement. By multiple logistic regression analysis, maternal age (OR 0.818; 95% CI 0.69-0.97; P 0.020), cervical length at diagnosis (OR 0.560; 95% CI 0.43-0.73; P < 0.001) and smoking status (OR 7.276; 95% CI 1.02-51.80; P 0.048) remained significantly associated with spontaneous preterm birth.The ROC curve from the multiple logistic regression analysis, including cervical length, maternal age and smoking status, had an area under the curve (AUC) of 0.952 (P < 0.001). The ROC curve for the risk score model incorporating all three variables had an AUC of 0.864 (95% CI 0.77-0.96; P < 0.001). A high-risk score was predictive of spontaneous preterm birth with a sensitivity of 75%, specificity of 84%, positive predictive value of 24%, and negative predictive value of 98%.Women with a high-risk score had a significantly reduced latency to delivery and poorer neonatal outcomes than those with a low-risk score. Conclusions: Patients at a high risk for spontaneous preterm birth despite pessary therapy may be identified using cervical length at diagnosis added to maternal age and smoking status.

The effect of cervical pessary on increasing gestational age at delivery in twin pregnancies with asymptomatic short cervix: a systematic review and meta-analysis of randomized controlled trials.

Objective: The incidence of preterm delivery is much higher in twin pregnancies than in singletons and even higher if a short cervical length is detected in the second trimester. Studies are contradictory regarding the efficacy of a cervical pessary to decrease preterm birth in twin pregnancies and short cervical length. To conduct a systematic review and meta-analysis investigating the efficacy of cervical pessary in prolonging gestation, preventing preterm birth, and reducing adverse neonatal outcomes in twin pregnancies with an asymptomatic short cervix. Data sources: PubMed, Scopus, Web of Science, and ClinicalTrials.org were searched for randomized controlled trials from inception to June 2023. Study eligibility criteria: In this study, randomized controlled trials comparing the cervical pessary to expectant management in the pregnant population with twin gestations and asymptomatic short cervix were included. Methods: The Cochrane risk-of-bias-2 tool for randomized controlled trials was used for the evaluation of the risk of bias in included studies. A meta-analysis was performed by calculating risk ratio and mean difference with their 95% confidence interval using the random effects model or fixed effect model on the basis of heterogeneity and accounting for potential covariates among the included randomized controlled trials. Results: A total of 6 randomized controlled trials were included in the analysis. Cervical pessary did not significantly increase the gestational age at delivery in twin pregnancies with asymptomatic patients (mean difference, 0.36 weeks [-0.27 to 0.99]; P=.270; I2=72.0%). Moreover, the cervical pessary use did not result in a reduction of spontaneous or all-preterm birth before 37 weeks of gestation (risk ratio, 0.88 [0.77-1.00]; P=.061; I2=0.0%). There was no statistically significant difference in the composite neonatal adverse outcomes (risk ratio, 1.001 [0.86-1.16]; P=.981; I2=20.9%), including early respiratory morbidity, intraventricular hemorrhage, necrotizing enterocolitis, and confirmed sepsis. Conclusion: The use of cervical pessary in twin pregnancies with asymptomatic short cervix does not seem to be effective in increasing the gestational age at delivery, preventing preterm birth, or reducing adverse neonatal outcomes. This indicates that alternative interventions should be sought for the management of this patient population.

Utility of cervical pessary in the prevention of preterm birth in triplet pregnancies: A single-center observational retrospective study of 165 triplet pregnancies.

OBJECTIVE: Premature births are a health problem arising in triplet pregnancies, resulting in high levels of morbidity and mortality. The objective of this study is to evaluate the utility of cervical pessaries in reducing prematurity (<34 weeks) in triplet pregnancies. METHODS: This is a single-center, retrospective case-control study regarding triplet pregnancies with follow-up at the La Paz University Hospital between 2000 and 2023. Maternal characteristics, obstetric and perinatal outcomes, and the use of cervical pessaries were examined. RESULTS: 165 triplet pregnancies were analyzed: 87 (52.7 %) in the case group (premature triplet pregnancies) and 78 in the control group (non-premature triplet pregnancies). A cervical pessary was inserted in 15 (17.2 %) triplet pregnancies in the case group and in 12 (16.7 %) triplet pregnancies in the control group (p = 0.92; OR = 1.04 (0.46-2.35)). A pessary was later inserted in the non-premature group (p = 0.01). The risk of preterm labor and the use of tocolytics ± glucocorticoids were found to be significantly more frequent in the premature group, with p = 0.01; OR = 2.30 (1.21-4.36) and p < 0.01; OR = 2.36 (1.23-4.44), respectively. Protocol-based cesarean sections were more frequent in the non-premature group (p < 0.01), while cesarean sections due to maternal complications (p < 0.01) and premature membrane rupture (p < 0.01) were more frequent in the premature group. CONCLUSION: The cervical pessary is not useful in preventing preterm births (< 34 weeks) in triplet pregnancies. It is likely that being pregnant with triplets is a powerful independent factor associated with prematurity, despite other pregnancy conditions. Women who are pregnant with triplets and at risk of preterm labor and those taking tocolytics ± glucocorticoids may benefit from pessary insertion.

Are Cervical Pessaries Effective in Preventing Preterm Birth?

Preterm births are a significant concern, as they can have serious consequences for both infants and mothers. It is crucial to identify risk factors associated with preterm birth and to implement effective interventions, such as progesterone, cervical pessary, and cervical cerclage, to prevent it. This systematic review aims to evaluate the efficacy of cervical pessary in reducing spontaneous preterm delivery. However, cervical pessaries have limited research and conflicting findings when compared to other interventions for preventing preterm labor. Therefore, this review seeks to analyze various studies to evaluate their overall effectiveness and better understand their role in treating this vulnerable population. The literature search was conducted using PubMed between January and September 2023, and the systematic review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The results of this review highlight the importance of continued research into mitigation strategies for preterm birth. There is some evidence that indicates that using cervical pessaries before 34 weeks can be effective. While some studies have reported positive outcomes when cervical pessaries are combined with other treatments like progesterone, there is no solid statistical evidence to support this claim. Furthermore, additional research is needed to comprehend the impact of singleton pregnancies and long-term outcomes for both mothers and infants.

The Arabin cervical pessary for the prevention of preterm birth in twin-to-twin transfusion syndrome treated by fetoscopic laser coagulation: a multicenter randomized controlled trial.

BACKGROUND: Miscarriage and preterm birth are leading causes of loss and disability in monochorionic twins after laser treatment of twin-twin transfusion syndrome. OBJECTIVE: This study aimed to investigate the use of cervical pessary to reduce preterm birth before 32 weeks of gestation in monochorionic diamniotic twin pregnancies after fetal surgery for twin-twin transfusion syndrome. STUDY DESIGN: In this open-label multicenter randomized trial, pregnant women carrying monochorionic diamniotic twins requiring fetoscopic laser coagulation for twin-twin transfusion syndrome were randomly assigned in a 1:1 ratio to pessary placement or conservative management. The primary outcome was birth before 32 weeks of gestation. The secondary outcomes were birth before 28, 30, 34, or 37 weeks of gestation; preterm premature rupture of membranes; fetal and neonatal survival; and a composite of maternal and neonatal complications. The estimated sample size was 364 patients, with 182 cases in each arm of the study. The analysis was performed according to the intention-to-treat principle. Moreover, 2 interim analyses were planned. RESULTS: The trial was stopped prematurely after the first planned interim analysis for futility. Overall, 137 women were included in the analysis, 67 in the pessary group and 70 in the conservative management group. Preterm birth before 32 weeks of gestation occurred in 27 of 67 women (40.3%) in the pessary group and in 25 of 70 women (35.7%) in the conservative management group (adjusted odds ratio, 1.19; 95% confidence interval, 0.58-2.47; P=.63). No differences between groups was observed in the rate of deliveries before 28, 30, 34, and 37 weeks of gestation. Overall survival to delivery was 91.2% (125/137) for at least 1 twin, and 70.8% (97/137) for both twins, with no difference between groups. Neonatal survival at 30 days was 76.5% (208/272). There was no difference between the groups in maternal or neonatal morbidity. CONCLUSION: In monochorionic diamniotic twin pregnancies requiring fetal therapy for twin-twin transfusion syndrome, routine use of cervical pessary did not reduce the rate of preterm birth before 32 weeks of gestation.

Development of children born to women with twin pregnancies treated with cervical pessary or vaginal progesterone: Follow-up of a randomized controlled trial.

INTRODUCTION: Preterm birth is the most common cause of neonatal morbidity and mortality. Women with twin pregnancies and a short cervical length are at high risk for preterm birth. Vaginal progesterone and cervical pessary have been proposed as potential strategies to reduce preterm birth in this high-risk population. Therefore, we aimed to compare the effectiveness of cervical pessary and vaginal progesterone in improving developmental outcomes of children born to women with twin pregnancies and mid-trimester short cervical length. MATERIAL AND METHODS: This was a follow-up study (NCT04295187) of all children at 24 months of age, born from women treated with cervical pessary or progesterone to prevent preterm birth in a randomized controlled trial (NCT02623881). We used a validated Vietnamese version of Ages & Stages Third Edition Questionnaires (ASQ-3) and a red flag questionnaire. In surviving children, we compared the mean ASQ-3 scores, abnormal ASQ-3 scores, the number of children with any abnormal ASQ-3 scores and red flag signs between the two groups. We reported the composite outcome of perinatal death or survival with any abnormal ASQ-3 score in offspring. These outcomes were also calculated in a subgroup of women with a cervical length ≤28 mm (<25th percentile). RESULTS: In the original randomized controlled trial, we randomized 300 women to pessary or progesterone. After counting the number of perinatal deaths and lost to follow-up, 82.8% parents in the pessary group and 82.5% parents in progesterone group returned the questionnaire. The mean ASQ-3 scores of the five skills and red flag signs did not differ significantly between the two groups. However, the percentage of children having abnormal ASQ-3 scores in fine motor skills was significantly lower in the progesterone group (6.1% vs 1.3%, P = 0.01). There were no significant differences in the composite outcome of perinatal death or survival with any abnormal ASQ-3 score in unselected women and in those with cervical length ≤28 mm. CONCLUSIONS: Cervical pessary and vaginal progesterone may have comparable effects on developmental outcomes in children at ≥24 months of age, born to women with twin pregnancies and short cervical length. However, this finding could be likely due to a lack of study power.

Prevention of Preterm Birth by Cervical Pessary Combined with Vaginal Progesterone: a Systematic Review and Meta-analysis with Trial Sequential Analysis.

This study was to assess the effectiveness of cervical pessary combined with vaginal progesterone for the prevention of preterm birth (PTB). Ten studies about singleton [five randomized controlled trials (RCTs), vs vaginal progesterone; four cohorts, vs vaginal progesterone; two cohorts, vs cervical cerclage + vaginal progesterone] and two cohort studies about multiple pregnancies (vs vaginal progesterone) were included after searching electronic databases. For singleton pregnancies, the meta-analysis of three non-RCTs [relative risk (RR) = 0.41, p = 0.001] or total trials in non-Asian country (RR = 0.56, p = 0.03) revealed that compared with vaginal progesterone alone, cervical pessary + vaginal progesterone treatment had significant effectiveness on preventing PTB < 34 weeks, but not for five RCTs; meta-analysis of two trials showed that cervical pessary + vaginal progesterone had no significant prevention effects of PTB compared with cervical cerclage + vaginal progesterone. For multiple pregnancies, meta-analysis of two trials showed that compared with vaginal progesterone, cervical pessary + vaginal progesterone treatment increased neonatal birth weight (standardized mean difference = 0.50, p = 0.01). Trial sequential analysis implied additional studies were required. Four studies vs other controls (pessary, three-combined, tocolysis, conservative or no treatment; one study, each) were selected for systematic review. In conclusion, cervical pessary combined with vaginal progesterone may be safe and effective to prevent PTB in singleton pregnancies and increase neonatal birth weight in the multiple pregnancies compared with vaginal progesterone alone.

Implications of training for pessary placement and accuracy of cervical length measurements after pessary placement: A prospective, double-blind, randomized clinical trial.

BACKGROUND: Cervical pessary placement as an intervention for preterm birth prevention in women with a short cervix is a simple, painless procedure with few complications and a reasonable cost. Its efficacy depends on the expertise of the obstetrician performing the procedure. Therefore, it is reasonable to assume that untrained obstetricians with no expertise in pessary placement are more likely to insert the pessary incorrectly, thereby reducing its efficacy. Nevertheless, the impact of pessary placement expertise and training, as well as the accuracy of cervival length measurements, has never been evaluated. OBJECTIVE: To evaluate the impact of providing training for pessary placement to obstetricians with no expertise in this intervention. To this end, the percentage of correct pessary placements and accuracy of cervical length measurements after pessary placement achieved by obstetricians who received such training was compared with the results achieved by obstetricians who did not receive any training. METHODS: This prospective, double-blind, randomized clinical trial included 91 pregnant women requiring a cervical pessary due to a short cervix. Patients were assigned at random to a group treated by untrained obstetricians with no expertise in pessary placement (untrained group, n = 45) or to a group treated by trained obstetricians with no expertise in pessary placement (trained group, n = 46). The primary outcomes were the quality of pessary placement and the accuracy of cervical length measurements after pessary placement. RESULTS: Obstetricians in the trained group achieved a significantly higher percentage of correct pessary placements than obstetricians in the untrained group (97.8 % and 65.2 %, respectively; p < 0.001). No significant differences were observed between groups in terms of the accuracy of cervical length measurements after pessary placement (p = 0.661), and both groups showed moderate to good agreement with the expert's measurements (intraclass correlation coefficient 0.840 and 0.749, respectively). No differences in pregnancy outcomes were observed between groups. CONCLUSION: This study showed that providing training in pessary placement to obstetricians with no expertise in this procedure increases the quality of pessary placement. Furthermore, the inconsistent results found in pessary studies may be explained, in part, by a lack of training in pessary placement.

Does a cervical pessary reduce the rate of preterm birth in women with a short cervix?

OBJECTIVES: To evaluate neonatal outcomes after the use of a cervical pessary in Japanese women with short cervical length (CL) less than 25 mm. METHODS: This multicenter study involved women with singleton pregnancies between 20 and 29+6 gestational weeks and a CL of less than 25 mm. The primary outcome was preterm birth (PTB) before 34 weeks of gestation. This study was registered in the Japan Registry of Clinical Trials (JRCT: jRCTs042180102). RESULTS: Two hundred pregnant women were enrolled; 114 in the pessary group and 86 in the expectant management group as controls. In the pessary group, all 114 neonates were investigated for perinatal outcomes, and 112 pregnant women were investigated for primary, and secondary outcomes. In the control group, 86 pregnant women were investigated for primary and secondary outcomes and 86 neonates were investigated for neonatal outcomes. There were no significant differences in PTB in ≤34, ≤37, and ≤28 weeks of gestation or in preterm rupture of membranes (PROM) ≤34 weeks between the groups. The gestational weeks at birth and birth weight were significantly higher in the pessary group. Regression analysis demonstrated that the CL decreased without a pessary, whereas the shortening rate was suppressed during the intervention. No significant differences were observed in adverse neonatal outcomes, chorioamnionitis, or preterm PROM. CONCLUSIONS: The cervical pessary effectively reduced CL shortening during pregnancy resulting in an average increased gestational age, however, did not reduced the rates of preterm birth.

Transvaginal Sonographic Assessment Following Cervical Pessary Placement for Preterm Birth Prevention.

Background Transvaginal sonographic cervical length assessment identifies pregnant women at risk for preterm birth, and the subsequent placement of a cervical pessary may reduce this risk. The mechanism of action remains uncertain, and postplacement transvaginal sonography may provide further insight into the controversial efficacy of this therapy. Objective To identify any pre- or postplacement sonographic findings associated with preterm delivery following cervical pessary insertion among at-risk women. Materials and Methods This retrospective cohort study utilized electronic medical record and imaging review of all women identified within a large tertiary care health system having undergone cervical pessary placement for preterm birth risk reduction and subsequently delivered between January 2013 (the adoption of this therapeutic option in our system) and March 2017. Indications for cervical pessary placement were guided by maternal-fetal medicine consultation and required a functional cervical length measurement on transvaginal sonography of 25 mm or less. Criteria for initial transvaginal cervical assessment included obstetric history, multiple gestation, and current concern on transabdominal imaging for cervical shortening. All pre- and postplacement transvaginal sonographic measurements were determined for study purposes by re-review of each patient's images by a single author blinded to outcome. Results A total of 88 women were identified as having undergone cervical pessary placement for preterm birth prevention, and 52 yielded complete delivery and imaging data for inclusion. As expected, this was a high-risk population with 51.9% carrying multiple gestations, 32.7% with a history of prior preterm birth, and 11.6% with a history of cervical conization. Although previously hypothesized to represent the mechanism of action, neither the change in uterocervical or intracervical angle was associated with gestational age at delivery. Alternatively, preplacement imaging measurements of cervical funneling, anterior cervical length, and cervical diameter were significantly associated with appropriate pessary placement and decreased preterm birth. Forty-two subjects (80.8%) demonstrated both the anterior and posterior aspects of the cervix within the pessary (appropriate placement) and 95.2% of these subjects demonstrated cervical funneling on initial imaging compared with 25% of those with inappropriate placement ( p = 0.002). Anterior cervical length less than 20 mm and cervical diameter less than 33 mm were associated with preterm delivery less than 28 weeks (16.7 vs. 0%, p = 0.039), and anterior cervical length less than 20 mm was associated with preterm delivery less than 32 weeks (41.7 vs. 10.7%, p = 0.025). Cervical diameter less than 33 mm correlated with an "inappropriately placed" pessary among 83.3% in comparison to 48.7% ( p = 0.048) of women with a cervical diameter less than 33 mm. Significant associations were noted between postplacement functional cervical length measurements and preplacement anterior cervical length ( p = 0.001) and cervical diameter ( p = 0.012). Conclusion Contrary to current thinking, no significant changes in uterocervical and intracervical angle following cervical pessary placement were identified. However, preplacement sonographic measurement of funneling, anterior cervical length, and cervical diameter are predictive of appropriate pessary placement and extreme preterm birth. These may represent markers for candidacy of cervical pessary placement. Postplacement transvaginal sonography represents an important tool to assess potential efficacy of this therapeutic modality, and further investigation of these factors is warranted.

Cervical pessary for preventing preterm birth in singletons and twin pregnancies: an update systematic review and meta-analysis.

OBJECTIVES: To evaluate the effectiveness of cervical pessary in preventing preterm birth (PTB) and improving perinatal outcomes among singleton and twin pregnancies. METHODS: Electronic databases were systematically searched from their inception until 14 March 2019. Randomized clinical trials comparing the effectiveness of cervical pessary placement with expectant management were included. The primary outcome was the incidence of PTB <34 weeks. RESULTS: Thirteen studies were included, involving eight studies about singleton and six studies about twin pregnancies. For singleton pregnancies with short cervical length, cervical pessary, comparing with expectant treatment, seemed have no effectiveness in preventing PTB <34 weeks (relative risk, 95% confidence interval, 0.73, 0.42-1.28), <37 weeks (0.69, 0.43-1.09), and <28 weeks (0.79, 0.42-1.48); while for twin pregnancies with short cervical length, cervical pessary also did not reduce the risk of PTB <34 weeks (0.81, 0.49-1.35), <37 weeks (0.93, 0.83-1.05), and <28 weeks (0.72, 0.38-1.38). However, cervical pessary seemed have the effectiveness of reducing the risk of spontaneous PTB <28 weeks (0.50, 0.25-0.99) and low birth weight (<1500 g) (0.68, 0.50-0.94) among twin pregnancies with short cervical length. In addition, cervical pessary increased the rate of vaginal discharge and did not improve perinatal outcomes among both singleton and twin pregnancies. CONCLUSIONS: Comparing with the expectant treatment, the effectiveness of cervical pessary for reducing the risk of PTB remains uncertain. Additional trials are warranted to further evaluate the effectiveness of cervical pessary.

Cervical pessary plus vaginal progesterone in a singleton pregnancy with a short cervix: an experience-based analysis of cervical pessary's efficacy.

BACKGROUND: Several studies were published about cervical pessary, with controversial results. These studies demonstrated that the patient follow-up after pessary insertion is very different between the study centers and the number of pessary insertions per center was often <30 cases. This study aims to determine cervical pessary performance in singleton pregnancies with a short cervix based on a single center learning curve. METHODS: Between 2011 and 2018, 128 singleton pregnancies between 18 and 24 gestational weeks with a short cervix (<25 mm) were referred to our clinic. All cases were treated with progesterone, and when available in our supplies (due to low resources) cervical pessary was also offered. Three groups were created for statistical analysis: Group 1 (n = 33), treated with progesterone-only; Groups 2 and 3, treated with cervical pessary plus progesterone. Group 2 included the first cases (n = 30) of pessary, defined by a learning curve and cumulative sum analysis, while Group 3 included the subsequent 65 cases. The primary outcome was preterm birth (PTB) < 34 gestational weeks. RESULTS: The learning curve was performed with all cases of pessary plus progesterone, and 30 patients were obtained as the number needed for learning, in our study with two operators. The PTB rate < 34 weeks was 27.3, 20, and 4.6% in groups 1, 2, and 3, respectively. There was no significant difference between Group 1 and 2 (OR 1.1; 95% CI 0.066 - 18.45; p = .945). When comparing Groups 1 and 3 there was a significant difference in PTB rates (OR 0.08; CI95% 0.01-0.42; p = .003). Considering Kaplan-Meyer Survival analysis, we can observe that the performance of progesterone alone (Group 1) was similar to Group 2 (progesterone + first 30 cases of pessary) (p = .432), but the performance of Group 3 (progesterone + subsequent 65 cases of pessary) and Group 1 shows a statistically significant difference (p = .011). CONCLUSION: Learning curve and cumulative sum analysis determined that the application and surveillance of at least 30 patients is required to see significant improvements in the primary outcome of PTB < 34 weeks.

Pessary use in patients diagnosed with short cervix and cervical insufficiency.

OBJECTIVE: The aim was to evaluate the effectiveness of Arabin pessary use in patients with cervical insufficiency or short cervix before the 24th week of gestation and the impact of cervical examination findings prior to pessary application on the outcome in terms of the gestational week. MATERIALS AND METHODS: In our study, among the pregnancies between the 12th and 24th gestational weeks, 60 pregnant women with a preterm delivery history and/or cervical length less than 25 mm were included. Among these 60 patients, 43 of them had a short cervix, 17 of them had cervical insufficiency. Routine medical and obstetric history was obtained. In the vaginal examination, the cervix was evaluated in terms of patency, dilatation, and position. Cervical length, presence of debris, and funneling were evaluated by transvaginal ultrasound. After receiving patients' approval a cervical pessary was applied to patients. Pessaries of pregnant women with 37 weeks of gestation were removed. Before reaching the 37th gestation week, pessaries were withdrawn in patients who had ongoing vaginal bleeding, premature rupture of membranes, and preterm contractions unresponsive to tocolytic treatment. RESULTS: Thirty-one pregnant women (51.7%) out of 60 pregnant women who underwent pessary, delivered at 37 weeks and below. Delivery rates in the short cervical measurement group and cervical insufficiency group at ≤28 weeks, ≤34 weeks and ≤37 weeks were respectively (n = 21) 34.8% vs 36.3% (p = 0.976), (n = 29) 41.8% vs 64.7% (p = 0.111), (n = 31) 44.2% vs 70.6% (p = 0.888). The presence of cervical funneling before pessary application shows a statistically significant difference in terms of patient's giving birth before or after 28 weeks (p = 0.033). In patients with cervical funneling, there was a significant increase in a birth before 28 weeks. Depending on whether or not patients applying with pain need for tocolysis, it shows the statistically meaningful difference in terms of the patients giving birth before or after 34 weeks (p = 0.001) (OR 7, 61, 95% GA 2.4-24.6). In the group without the need for tocolysis, there is a meaningful increase in birth after 34 weeks. CONCLUSIONS: Our findings showed that, alongside the defined cervical risk factors, cervical funneling and the need for tocolysis are remarkable prognostic variables in pessary application.

Effectiveness of cervical pessary in women with arrested preterm labor compared to those with asymptomatic cervical shortening.

OBJECTIVE: To determine whether the effectiveness of cervical pessary is different in women who experienced cervical shortening after a threatened preterm labor episode compared to those with asymptomatic short cervix. METHODS: Retrospective study on singleton pregnancies at risk for preterm delivery (PTD) due to cervical length <25 mm before 28 weeks, who were treated with Arabin cervical pessary. Two groups of patients were compared: those who had contractions causing shortening of the cervix, prior to pessary placement, and those who had asymptomatic cervical shortening. Patients carrying a multiple pregnancy and those who underwent iatrogenic PTD were excluded. The primary outcome was the incidence of PTD at different gestational ages. Secondary outcome was the rate of preterm premature rupture of membrane (pPROM). The groups were compared using univariate and multivariate analyses. RESULTS: 115 patients that met the inclusion criteria were identified. Of these, 91 (79%) had asymptomatic cervical shortening, while 24 (21%) had an episode of threatened preterm labor that resolved, and the pessary was placed after the contractions had stopped. The two groups were similar for maternal characteristics, obstetric history, mean gestational age and length of the cervix at the time of pessary insertion. The median gestational age at delivery was significantly lower (36.4 vs 38.0 weeks, p = .02), and the incidence of PTD significantly higher (58.3% vs 30.8%, OR 4.69, 95% CI 1.68-13.1, p < .01) among women who had arrested preterm labor before the pessary was placed compared to the asymptomatic group, after controlling for confounders. The incidence of PTD before 34 and before 32 weeks was also significantly higher in the symptomatic group (p = .02 and p = .005, respectively). Women with asymptomatic cervical shortening had a longer interval between the placement of the pessary and delivery (median 15 weeks). pPROM occurred with a similar incidence in both groups. CONCLUSIONS: Arabin cervical pessary to prevent preterm delivery seems be less effective in women with a short cervix following an episode of threatened preterm labor than in those with asymptomatic cervical shortening in the second trimester. This finding may help physicians to select patients in which cervical pessary is more likely to be effective, and to improve patient's counseling about this intervention.

The Arabin pessary to prevent preterm birth in women with a twin pregnancy and a short cervix: the STOPPIT 2 RCT.

BACKGROUND: Preterm birth is common in twins and accounts for significant mortality and morbidity. There are no effective preventative treatments. Some studies have suggested that, in twin pregnancy complicated by a short cervix, the Arabin pessary, which fits around the cervix and can be inserted as an outpatient procedure, reduces preterm birth and prevents neonatal morbidity. OBJECTIVE: STOPPIT 2 aimed to evaluate the clinical utility of the Arabin cervical pessary in preventing preterm birth in women with a twin pregnancy and a short cervix. DESIGN: STOPPIT 2 was a pragmatic, open label, multicentre randomised controlled trial with two treatment group - the Arabin pessary plus standard care (intervention) and standard care alone (control). Participants were initially recruited into the screening phase of the study, when cervical length was measured. Women with a measured cervical length of ≤ 35 mm were then recruited into the treatment phase of the study. An economic evaluation considered cost-effectiveness and a qualitative substudy explored the experiences of participants and clinicians. SETTING: Antenatal clinics in the UK and elsewhere in Europe. PARTICIPANTS: Women with twin pregnancy at < 21 weeks' gestation with known chorionicity and gestation established by scan at ≤ 16 weeks' gestation. INTERVENTIONS: Ultrasound scan to establish cervical length. Women with a cervical length of ≤ 35 mm at 18+ 0-20+ 6 weeks' gestation were randomised to standard care or Arabin pessary plus standard care. Randomisation was performed by computer and accessed through a web-based browser. MAIN OUTCOME MEASURES: Obstetric - all births before 34+ 0 weeks' gestation following the spontaneous onset of labour; and neonatal - composite of adverse outcomes, including stillbirth or neonatal death, periventricular leukomalacia, early respiratory morbidity, intraventricular haemorrhage, necrotising enterocolitis or proven sepsis, all measured up to 28 days after the expected date of delivery. RESULTS: A total of 2228 participants were recruited to the screening phase, of whom 2170 received a scan and 503 were randomised: 250 to Arabin pessary and 253 to standard care alone. The rate of the primary obstetric outcome was 18.4% (46/250) in the intervention group and 20.6% (52/253) in the control group (adjusted odds ratio 0.87, 95% confidence interval 0.55 to 1.38; p = 0.54). The rate of the primary neonatal outcome was 13.4% (67/500) and 15.0% (76/506) in the intervention group and control group, respectively (adjusted odds ratio 0.86, 95% confidence interval 0.54 to 1.36; p = 0.52). The pessary was largely well tolerated and clinicians found insertion and removal 'easy' or 'fairly easy' in the majority of instances. The simple costs analysis showed that pessary treatment is no more costly than standard care. LIMITATIONS: There was the possibility of a type II error around smaller than anticipated benefit. CONCLUSIONS: In this study, the Arabin pessary did not reduce preterm birth or adverse neonatal outcomes in women with a twin pregnancy and a short cervix. The pessary either is ineffective at reducing preterm birth or has an effect size of < 0.4. FUTURE WORK: Women with twin pregnancy remain at risk of preterm birth; work is required to find treatments for this. TRIAL REGISTRATION: Current Controlled Trials ISRCTN98835694 and ClinicalTrials.gov NCT02235181. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 44. See the NIHR Journals Library website for further project information.

Women who are pregnant with twins have a much higher risk of going into labour early and having an early (preterm) birth than women who are pregnant with only one baby. For this reason, babies who are twins are much more likely to die or to have serious health complications in the first months of life. Although we know that women with twin pregnancy are at risk, there are no treatments that are recommended to prevent early births. Some studies have suggested that the Arabin pessary can help. The Arabin pessary is a silicone ring that fits around the cervix (neck of the womb). The pessary can be put in place in a clinic without any need for an anaesthetic. Some studies have suggested that the Arabin pessary helps and others have suggested that it does not. It appears to be most helpful when the cervix (neck of the womb) is already shortening. Shortening of the neck of the womb is a sign that early birth is even more likely. We asked women with twin pregnancy to take part in STOPPIT 2. Women who agreed had an ultrasound scan of the neck of the womb, which measured its length. Those with a short cervix were randomised to be offered the Arabin pessary (in addition to standard care) or standard care alone. This allocation was carried out 'at random' by a computer. We followed women up until the end of their pregnancy and collected information on the babies' health after birth. We found that the Arabin pessary did not reduce the risk of an early birth; nor did it reduce the risk of health complications for the baby. We conclude that the Arabin pessary should not be used for this purpose.

Uterovesical fistula caused by cervical pessary placed for the prevention of preterm delivery - case report.

Uterovesical fistulas are the rarest of all urogenital fistulas, mostly occurring as a complication of cesarean section. We present a case of a 32-year-old woman, who noticed continuous vaginal urine leakage starting immediately after a vaginal delivery. The shortening of the uterine cervix was reported at 26th week of gestation, and a cervical pessary was placed. Shortly after delivery, the patient noticed the loss of urinary continence control, and she was diagnosed with urinary incontinence and hematuria. The office diagnostic hysteroscopy revealed uterovesical fistula. The correction procedure by transabdominal approach was performed by the team of gynecological and urological surgeons. One year of follow-up, the patient reports no symptoms related to lower urinary tract dysfunction. Based on the literature search, we believe that his is the first study of a uterovesical fistula followed by the use of a cervical pessary for the prevention of preterm delivery. Our case is a clear reminder that symptoms of urinary incontinence after vaginal delivery should be carefully managed.

Combined therapy with vaginal progesterone, Arabin cervical pessary and cervical cerclage to prevent preterm delivery in high-risk women.

PURPOSE: Preterm birth is the leading cause of perinatal morbidity and mortality. Vaginal progesterone cervical cerclage and Arabin cervical pessary are considered as preventive treatments in women at risk for preterm birth. However, there is less evidence as to which of these interventions is the preferred management. The current study aims was to compare the outcome of pregnancy in women with a short cervical length managed with 4 different treatment protocols: therapy with vaginal progesterone, cervical cerclage and an Arabin cervical pessary (group A), Arabin cervical pessary and vaginal progesterone (group B), cervical cerclage and vaginal progesterone (group C), or vaginal progesterone alone (group D). METHODS: A retrospective cohort study of singleton pregnancies managed in three tertiary medical centers between September 2011 and December 2017. RESULTS: In the study period, 286 pregnant women underwent vaginal ultrasonography between 15 and 29 weeks gestation. They all had a short cervical length (≤25 mm). Of these, 18 (6.3%), 120 (41.9%), 38 (13.3%) and 110 (38.5%) patients received treatment classifying them into groups A, B, C, and D, respectively. A significantly higher rate of patients in group A had either a history of cervical incompetence (44.4 versus 9.2 versus 7.9 and 0.9%, respectively, p = .0001) or a cervical procedure (61.1 versus 37.5 versus 28.9 and 27.3%, respectively, p = .027) compared to patients in group B, C, and D. Despite having a shorter cervical length at recruitment in group A (median (range); 14.5 (0-25) versus 15 (0-25) versus 15.5 (0-25) and 19 (2-25) mm, respectively, p = .002) the rate of spontaneous preterm delivery <37-week gestation was similar across groups (44.4 versus 32.5 versus 36.8 versus 32.7%, respectively, p = .665). CONCLUSION: A combined rescue therapy involving vaginal progesterone, cervical cerclage, and Arabin cervical pessary emerges as a promising management strategy in pregnant women who have a short cervical length and a high background risk for preterm delivery. This combination may prolong their pregnancy and safely bring them near term. Additional studies are needed to confirm these preliminary findings.