Use Of Cervical Pessary Research Articles

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

BackgroundMiscarriage and preterm birth are leading causes of loss and disability in monochorionic twins following laser treatment for twin-twin transfusion syndrome. ObjectiveWe investigated the use of the cervical pessary to reduce preterm birth before 32 weeks in monochorionic diamniotic twin pregnancies after fetal surgery for twin-twin transfusion syndrome. Study designIn 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. Secondary outcomes were birth before 28, 30, 34 or 37 weeks, preterm 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. Two interim analyses were planned. ResultsThe trial was stopped prematurely after the first planned interim analysis for futility. One hundred thirty-seven women were included in the analysis, 67 in the pessary and 70 in the conservative management group. A preterm birth before 32 weeks occurred in 27/67 women (40.3%) in the pessary group and in 25/70 women (35.7%) in the conservative management group (aOR, 1.19; 95%CI, 0.58-2.47, P=.63). No significant differences between groups were observed in the rate of deliveries before 28, 30, 34 and 37 weeks, respectively. Overall survival to delivery was 91.2% (125/137) for at least one twin and 70.8% (97/137) for both twins, with no differences between groups. Neonatal survival at 30 days was 76.5% (208/272). There were no differences between groups in maternal or neonatal morbidity. ConclusionIn monochorionic diamniotic twin pregnancies requiring fetal therapy for twin-twin transfusion syndrome, routine use of cervical pessary did not reduce the rate of preterm delivery before 32 weeks.

Screening and prevention of preterm birth in twin pregnancies.

Preterm birth (PTB) is commonest cause of perinatal mortality and morbidity in multiple pregnancies with significant long-term sequelae. The etiology of PTB is multifactorial. Universal screening by a transvaginal assessment of cervical length (CL) at midtrimester scan is recommended for all women with twin pregnancies. Women with CL≤25mm should be offered prophylactic vaginal progesterone to mitigate the risk of PTB. Other modalities like home uterine activity monitoring, digital cervical examination, fetal fibronectin (FFN) assessment, and screening for infections are not recommended. History-indicated cerclage is not advised in unselected twin pregnancies, but a combination of physical examination-indicated cerclage, tocolytics, and antibiotics may be considered in twin pregnancies with a dilated cervix prior to 24 weeks' gestation. Routine use of cervical pessary is not advised and should be limited to research settings. Neither transvaginal CL nor FFN assessment is supported by evidence to predict the risk of PTB in symptomatic women with multiple pregnancies. More research is warranted to develop and validate algorithms to predict PTB to provide individualized care to these high-risk pregnancies.

Prevention of preterm birth with pessary in singletons (PoPPS): randomized controlled trial.

To determine if pessary use prevents preterm birth (PTB) in women with singleton pregnancy, with short cervical length (CL) measured on transvaginal sonography (TVS) and without prior spontaneous PTB (sPTB). This was an open-label multicenter randomized trial of asymptomatic women presenting at 18 + 0 to 23 + 6 weeks' gestation with a singleton pregnancy, CL ≤ 25 mm on TVS and no prior sPTB. sPTB included those with spontaneous onset of labor and those with rupture of membranes prior to labor. Subjects were randomized to receive either a Bioteque cup pessary or no pessary. Pessaries were inserted by trained maternal-fetal medicine staff. Vaginal progesterone was recommended to women with CL ≤ 20 mm. The primary outcome was PTB < 37 weeks. A sample size of 121 women in each group (n = 242) was needed to detect a reduction in the primary outcome from 30% in the no-pessary group to 15% in the pessary group. The trial was stopped early before complete enrollment. Between 17 March 2014 and 29 July 2016, 17 383 women underwent CL measurement on TVS. Of these, 422 (2.4%) had CL ≤ 25 mm and 391 (92.7%) met the full eligibility criteria, of which 122 (31.2%) agreed to randomization. Sixty-one (50%) women were randomized to the pessary group and 61 (50%) to the no-pessary group. Baseline characteristics were similar between the groups. There were no significant differences between the pessary and no-pessary groups in the rate of PTB < 37 weeks (43% vs 40%; relative risk 1.09; 95% CI, 0.71-1.68) or in secondary outcomes, such as rate of PTB < 34 weeks, rate of PTB < 28 weeks, gestational age at delivery, birth weight and rate of composite adverse neonatal outcome. Cervical pessary use was not associated with prevention of PTB in women with a singleton pregnancy, short CL on TVS and no prior sPTB in this small, underpowered randomized controlled trial. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

First Experience Using Brazilian Ingamed&amp;lt;sup&amp;gt;&amp;amp;reg&amp;lt;/sup&amp;gt; Cervical Pessary in Twin Pregnancy: A Case Series

Background: The rate of prematurity in twin pregnancies is higher than 50%. Due to its multifactorial nature, different strategies are necessary to reduce the incidence of premature birth or to increase the gestational age at birth of pregnancies at risk. In this context, cervical pessary may be indicated in twin pregnancies with short cervix. Methods: In this case series, we describe six twin pregnancies that were considered as high-risk for preterm labor due to short cervix (CL < 30 mm) at second trimester and multiple risk factors for prematurity. Several strategies were associated for the goal of delaying gestational age at birth. The main strategies were: removal of labor activities, treatment of infections, vaginal micronized progesterone 400 mg/day and vaginal pessary insertion (Ingamed&reg Brazil). Results: The gestational age of insertion of the pessary ranged from 16 to 24 weeks. The gestational age of birth ranged from 26 to 34 weeks. Three of the pregnancies were delivered due to spontaneous onset of labor, and three were delivered due to medical reasons. The mean length of pregnancy since pessary insertion to birth was 9 weeks (range 2 to 17 weeks). All infants without severe fetal malformation were discharged from the hospital without major sequelae. Conclusion: The use of cervical pessaries associated to micronized progesterone at a dose of 400 mg/day may be an option in the management of twins at risk for preterm birth. More controlled studies are needed to evaluate the simultaneous use of cervical pessary and progesterone on twin pregnancies.

Retrospective Cohort Study of Cervical Pessary Use in Women with Short Cervix at Risk of Preterm Delivery

ObjectiveA paucity of effective interventions exists for the prevention of preterm birth (PTB). Renewed interest has focused on cervical pessaries, which have the benefits of being inexpensive, nonsurgical, and easily inserted and removed. In this study, we aim to describe our experience with this device in a Canadian tertiary care centre. Primary outcomes were rates of spontaneous or iatrogenic PTB before 37, 34, and 28 weeks gestation in pregnancies complicated by short cervix treated with cervical pessary. MethodsThis was a retrospective cohort study of women with singleton, twin, and triplet pregnancies with pessary placement from August 2013 to March 2015 in the Urogynecology Clinic at the Lois Hole Hospital for Women in Edmonton, AB. Included women were deemed to be at high risk of PTB due to short cervix (≤25 mm) found on ultrasound. ResultsAmong 115 women included, pessaries were placed at a mean gestation of 25.3 weeks. Forty-nine singleton women (52.7%) delivered at term. Of these deliveries, 75% were spontaneous. Rates of PTB before 34 and 28 weeks gestation for all deliveries, respectively, were 37.4% and 10.4%. Removal data were available for 87.8% of patients, and the pessary remained in situ for a mean of 48 days. ConclusionIn this study's high-risk obstetrical population, the rates of preterm birth remained high. The effectiveness of pessary use, particularly when compared to other preventative strategies, remains a topic in need of further investigation. To our knowledge, this is the first study to contribute pessary data from a Canadian population.

Maternal sepsis complicating arabin cervical pessary placement for the prevention of preterm birth: a case report

BackgroundPreterm delivery is a major health problem and contributes to more than 50% of all neonatal and infant deaths. Recently, there has been a renewed interest in the use of cervical pessaries as a safe and effective intervention with few maternal side-effects for the prevention of preterm birth in both single and twin pregnancies.Case presentationA 43-year-old gravida 5, para 1 (previous preterm birth at 24 weeks) patient with an in vitro fertilization twin pregnancy had an Arabin cervical pessary placed at 19 weeks of pregnancy due to the presence of cervical funneling identified by ultrasound screening. She developed chorioamnionitis and sepsis and delivered at 21 3/7 weeks after extraction of the pessary.ConclusionSevere maternal infection may complicate pessary treatment for the prevention of preterm birth. Careful follow-up is necessary in women with a cervical pessary during pregnancy, particularly when important funneling is present.

Use of Cervical Pessary in the Management of Cervical Insufficiency.

Prevention of spontaneous preterm birth is an important public health priority. Pessary may be a potential therapy in cases of cervical insufficiency, in singleton and multiple gestations. Availability of transvaginal sonography for accurate assessment of cervical length is allowing for the tailoring of therapy to a more specific subset of patients who may benefit from this treatment. Pessary therapy is attractive given the favorable side effect profile, low cost, and ease of placement and removal. Large randomized trials are ongoing to validate initial favorable findings.

Prophylactic use of the Arabin cervical pessary in fetuses with severe congenital diaphragmatic hernia treated by fetoscopic endoluminal tracheal occlusion (FETO): preliminary experience.

The aim of this study was to describe whether the prophylactic use of a cervical pessary decreases the rate of premature birth in congenital diaphragmatic hernia (CDH) fetuses treated with fetoscopic tracheal occlusion (FETO). The study concerns a consecutive series of cases with CDH and FETO and a group of CDH without FETO. In a subgroup of the FETO group, a prophylactic cervical pessary was inserted the day following the procedure. Gestational age (GA) at birth was the primary outcome. Fifty-nine fetuses with FETO and 47 expectantly managed were included. The last 15 FETO had a cervical pessary inserted. The median GA at delivery in the FETO group with pessary was 35.1 weeks and was not different from that in the FETO group without a pessary (34.3 weeks; p = 0.28) but was below that in the expectantly managed group (38.3 weeks; p < 0.001). Early results suggest that prophylactic use of an Arabin cervical pessary does not prolong gestation of CDH fetuses treated with FETO. © 2015 John Wiley & Sons, Ltd.

Cervical pessary use and preterm birth.

Preterm birth remains a considerable public health concern and priority. Little headway has been made in the prevention of preterm birth despite considerable research in this area. New ideas and treatments are desperately needed. The pessary has emerged as a possible treatment for the prevention of preterm birth in both singleton and twin gestations. It appears to be low cost with minimal side effects. This review focuses on the available evidence for the use of cervical pessaries for the prevention of preterm birth, especially in a high-risk population with a shortened cervical length. Larger scale randomized-controlled trials are warranted before incorporation of the pessary into standard obstetrical practice.

Cervical pessaries for prevention of spontaneous preterm birth: past, present and future

This Review describes the rationale for the use of cervical pessaries to prevent spontaneous preterm birth and their gradual introduction into clinical practice, discusses technical aspects of the more commonly used designs and provides guidance for their use and future evaluation. Possible advantages of cervical pessaries include the easy, ‘one-off’ application, good side-effect profile, good patient tolerance and relatively low cost compared with current alternatives. Use of transvaginal sonography to assess cervical length in the second trimester allows much better selection of patients who may benefit from the use of a cervical pessary, but future clinical trials are needed to establish clearly the role of pessaries as a preterm birth prevention strategy worldwide.

Cervical pessary for preventing preterm birth.

Preterm 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. To evaluate the efficacy of cervical pessary for the prevention of preterm birth in women with risk factors for cervical incompetence. We 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). We 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. Two review authors independently assessed trials for inclusion. The 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). The 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.

Preterm Labor: Understanding of the Mechanism Involved to Improve Prediction and Prevention

Preterm birth is a significant problem occurring in around 10% of all deliveries and its increase is remarkable, even in developed countries. Being born under 37 weeks, and most importantly under 32 weeks, is the major cause of perinatal morbidity and mortality and accounts for the majority of neonatal deaths. Recent advances in perinatology and neonatology have increased survival rates, particularly for the extremely preterm baby. The associated morbidity for these survivors' remains significant, and up to one-quarter will have at least one major disability. This special issue focused in some aspect of the physiopathology of the preterm labor and different strategies to predict the patient at risk in order to improve the prevention of this pathology. This issue highlights the diversity of the physiopathology of preterm labor by including different points of view, such as focusing in the expression of steroid receptor coactivators in fetal membranes and its relationship with preterm labor. Using immunohistochemistry, western blot analysis, and real-time PCR, they demonstrate that SRC-1, SCR-2, p300, and PCAF proteins are present in nuclear extracts and display tissue-specific and labor-associated differential expression. In another paper, the authors propose a novel putative target for the prevention of infection-triggered preterm labor. They suggest that uterotonic effects of endothelin-1 (E-1) are mediated via sphingosine kinase (SphK). E-1 is a molecule that exerts potent oxytocic effects and is elevated in amniotic fluid obtained from preterm births. SphK plays a key role in ET-1-induced myometrial contractions and may represent a potential target for tocolysis to prevent preterm birth. In terms of prediction, a review accessing the accuracy of transvaginal sonographic cervical length in predicting preterm birth in women with twin pregnancy and symptoms of preterm birth is presented. The authors present a meta-analysis, using bivariate regression analysis, accounting for correlation between sensitivity and specificity. Despite the large variation in definition of preterm birth and cut-off point of cervical length and gestational age, they concluded that there is insufficient evidence to recommend the measurement of cervical length as a predictor of preterm birth in women with a twin pregnancy and symptoms of preterm birth because specificity and sensibility are low. With respect to prevention of preterm birth, a systematic review of the use of cervical pessaries and adjunctive therapies to cerclage is presented. The aim of one study was to evaluate the effective use of the cervical pessary to prevent preterm birth before 28, 34, and 37 weeks of gestation. Interestingly, one randomized controlled trial demonstrated a lower delivery rate prior to 34 weeks in the pessary group. Other studies, however, showed no positive effect. The author concluded that the cervical pessaries represent an affordable, safe, and reliable alternative for prevention of preterm birth in selected at-risk pregnant women. Nevertheless, more randomized clinical trials are needed before this device can be used in clinical practice. In another study, the authors reviewed publications that assessed the efficacy of adjunctive therapies used in addition to cervical cerclage as a preventive measure for preterm birth. The adjunctive therapies identified were progesterone, reinforcing or second cerclage placement, tocolytics, antibiotics, bedrest, and pessary. Even though small numbers of patients limited the strength of the conclusions, none of the studies clearly show the benefit of any adjunctive therapy used. By compiling these papers, we hope to improve the knowledge of clinicians and researchers with respect to this important cause of perinatal morbidity and mortality. Increasing the understanding of the physiopathology of the preterm labor and the strategies to prevent it are essential steps to avoid the consequence of this disease. S. E. Illanes J. K. Nien G. E. Rice

499: Use of cervical pessary for prevention of preterm birth in the short cervix population: a cost-effectiveness analysis

499: Use of cervical pessary for prevention of preterm birth in the short cervix population: a cost-effectiveness analysis

MOST WOMEN USE LESS‐EFFECTIVE CONTRACEPTIVE METHODS

In the Journal of Midwifery and Woman’s Health’s “Updates from the Literature” several recent studies are discussed. The Contraceptive CHOICE Project was designed to promote use of long-acting reversible contraception (LARC): intrauterine devices (IUDs) and subdermal implants. This article presents results of their prospective cohort study designed to determine failure rates for different forms of reversible contraception and to identify women at greatest risk for contraceptive failure. A second article presents results from the Pesario Cervical para Evitar Prematurida (PECEP) trial which examined cervical pessary use for women with short cervix gathering data from 5 hospitals in Spain. The PECEP trial supplies strong evidence that routine ultrasounds for cervical length followed by pessary placement in women with short cervix might be a relatively noninvasive and low-cost way to decrease the rate of preterm birth. A third article describes a study compared the normal progress of spontaneous and induced labors the finding of which support an unhurried approach to labor induction. Other literature of interest to midwives includes studies showing that women with hypertensive disorders of pregnancy are at greater risk for cardiovascular disease and that children born before 39 weeks’ gestation have lower school achievement in third grade. An additional study calls for more research needed on nonnutritive sweeteners and cardiovascular health.

Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial

Most previous studies of the use of cervical pessaries were either retrospective or case controlled and their results showed that this intervention might be a preventive strategy for women at risk of preterm birth; no randomised controlled trials have been undertaken. We therefore undertook a randomised, controlled trial to investigate whether the insertion of a cervical pessary in women with a short cervix identified by use of routine transvaginal scanning at 20-23 weeks of gestation reduces the rate of early preterm delivery. The Pesario Cervical para Evitar Prematuridad (PECEP) trial was undertaken in five hospitals in Spain. Pregnant women (aged 18-43 years) with a cervical length of 25 mm or less were randomly assigned according to a computer-generated allocation sequence by use of central telephone in a 1:1 ratio to the cervical pessary or expectant management (without a cervical pessary) group. Because of the nature of the intervention, this study was not masked. The primary outcome was spontaneous delivery before 34 weeks of gestation. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00706264. 385 pregnant women with a short cervix were assigned to the pessary (n=192) and expectant management groups (n=193), and 190 were analysed in each group. Spontaneous delivery before 34 weeks of gestation was significantly less frequent in the pessary group than in the expectant management group (12 [6%] vs 51 [27%], odds ratio 0·18, 95% CI 0·08-0·37; p<0·0001). No serious adverse effects associated with the use of a cervical pessary were reported. Cervical pessary use could prevent preterm birth in a population of appropriately selected at-risk women previously screened for cervical length assessment at the midtrimester scan. Instituto Carlos III.

Cervical pessary use and preterm birth: how little we know

Cervical pessary use and preterm birth: how little we know