Management of short cervix in twin-to-twin transfusion syndrome: a role for pessary placement following fetoscopic laser surgery?

BACKGROUND: Preterm labor and delivery is a major concern for patients with twin-to-twin transfusion syndrome undergoing fetoscopic laser surgery. A preoperative short cervix is a risk factor for preterm labor. Pessary placement is a short-acting intervention that may be useful to reduce this adverse event. OBJECTIVE: This study aimed to investigate the relationship between pessary placement and preterm delivery in monochorionic twin pregnancies with twin-to-twin transfusion syndrome and a short cervix before fetoscopic laser surgery. STUDY DESIGN: This was a retrospective study in 2 centers, including all pregnancies affected by twin-to-twin transfusion syndrome that underwent fetoscopic laser surgery with the Solomon technique between 2013 and 2022 (center A) and 2014 and 2022 (center B) with a preoperative cervical length below 25 mm. This study explored the correlation between cervical length and fetoscopic laser surgery-to-delivery interval following active or expectant management and compared perinatal outcomes between patients managed expectantly and patients managed with pessary placement, using multivariate analysis to control for potential confounders. Patients with a cervical length below 5 mm were not included in the comparative analysis. RESULTS: Of 685 patients, 134 met the inclusion criteria. Moreover, 21 patients were treated with a cervical cerclage and excluded from the analysis, leaving 113 patients for the final analysis. There was a significant negative correlation between cervical length at fetoscopic laser surgery and the risk of early delivery (adjusted odds ratio, 0.66; 95% confidence interval, 0.49-0.81; P<.001). The use of a pessary correlated with fewer patients delivering before 28 weeks of gestation (adjusted odds ratio, 0.28; 95% confidence interval, 0.09-0.75), fewer double neonatal demise (adjusted odds ratio, 0.2; 95% confidence interval, 0.05-0.75). Posthoc subgroup analysis suggested that these improvements were essentially noticeable for cervical lengths between 5 and 18 mm, where pessary placement was associated with an increased fetoscopic laser surgery-to-delivery interval (+24 days; 95% confidence interval, 0.86-42; P=.042) and later gestational age at delivery (+3.3 weeks; 95% confidence interval, 0.86-42; P=.035). CONCLUSION: Patients with a moderately shortened cervix, between 5 and 18 mm, may benefit from pessary placement after fetoscopic surgery for twin-to-twin transfusion syndrome, resulting in a reduction of adverse neonatal outcomes, double neonatal demise, and severe preterm delivery.

Use of the Arabin pessary in women at high risk for preterm birth: long-term experience at a single tertiary center in Malaysia.

BACKGROUND: Spontaneous preterm birth is a global issue that contributed to perinatal morbidities and mortalities worldwide. The study aimed to describe the experience at UKM Medical Center in managing women at high risk for spontaneous preterm birth using the Arabin pessary. METHODS: This is a retrospective observational study involving 58 pregnancies from 1st January 2013 to 31st December 2019. Inclusion criteria were previous mid-trimester miscarriage and/or preterm birth, previous cervical surgery or short cervical length on routine sonogram. The demographic data, characteristics of each pregnancy and details of outcomes and management were described. RESULTS: The majority of women were Malay with mean age and body mass index of 32.9 ± 4.2 years and 27.1 ± 6.3 kg/m2 respectively. The most frequent indications for Arabin pessary insertion were previous mid-trimester miscarriage (46.4%) and early preterm birth (17.2%). A total of 73.4% of these women had the pessary inserted electively at a mean cervical length of 31.6 ± 9.1 mm at median gestation of 15.0 weeks. They were managed as outpatient (56.9%), inpatient (24.1%) or mixed (19.0%) with combination of progestogen (81.0%) and 53.4% received antenatal corticosteroids. Spontaneous preterm birth at or more than 34 weeks gestation occurred in 74.1% with birthweight at or more than 2000 g (82.4%). Despite cervical funneling in 12 women (20.7%), 66.7% delivered at or later than 34 weeks gestation and 2 (16.7%) resulted in miscarriage. CONCLUSIONS: Insertion of the Arabin pessary is beneficial to prevent spontaneous preterm birth in pregnant women who are at high risk. In particular, early insertion and close monitoring allows the best possible outcomes. TRIAL REGISTRATION: This study was retrospectively registered with ClinicalTrials.gov ( NCT04638023 ) on 20/11/2020.

Cervical pessary for preventing preterm birth in twin pregnancies with maternal short cervix after an episode of threatened preterm labor: randomised controlled trial.

BACKGROUND: No intervention has proved effective to date in reducing the spontaneous preterm birth rate in twin pregnancies following an episode of threatened preterm labor and with a short cervix remaining. This study was designed to ascertain whether cervical pessaries are useful in preventing spontaneous preterm birth in women with twin pregnancies and a short cervix remaining after a threatened preterm labor episode. STUDY DESIGN: This open, randomized, controlled trial was conducted in 132 pregnant women who had not delivered 48 hours after a threatened preterm labor episode and had a short cervix remaining (≤20 mm between 240 and 296 weeks and ≤10 mm between 300 and 336 weeks). Patients were randomly assigned to cervical pessary (n = 67) or routine management (n = 65). The primary outcome was the spontaneous preterm birth rate before 34 weeks. Spontaneous preterm birth before 28 and 37 weeks and neonatal morbidity and mortality were also evaluated in an intention-to-treat analysis. RESULTS: Significant differences were observed in the spontaneous preterm birth rate before 34 weeks between the pessary and routine management groups (11 of 67 [16.4%] in the pessary group vs 21 of 65 [32.3%] in the control group; relative risk, 0.51 [confidence interval, 0.27-0.97]; P = .03). No significant differences were observed in the preterm birth rate < 28 weeks or < 37 weeks between groups. The pessary group less frequently required readmission for new threatened preterm labor episodes (4 of 67 [5.6%] vs 14 of 65 [21.5%]; relative risk, 0.28 [confidence interval, 0.10-0.80]; P = .009). Significant reduction was observed in the number of neonates weighing less than 2500 g (17.9% [24 of 134] vs 70.8% [92 of 130]; relative risk, 0.25 [confidence interval, 0.15-0.43]; P < .0001). CONCLUSION: Pessary use did significantly lower the spontaneous preterm birth rate before 34 weeks in twin pregnancies with maternal short cervix remaining after a threatened preterm labor episode. Pessary use also reduced the threatened preterm labor recurrence and neonates' weight less than 2500 g.

Should phenotype of previous preterm birth influence management of women with short cervix in subsequent pregnancy? Comparison of vaginal progesterone and Arabin pessary.

OBJECTIVE: To 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. METHODS: This 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. RESULTS: Between 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. CONCLUSIONS: Cervical 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.

Cervical pessary to reduce preterm birth <34 weeks of gestation after an episode of preterm labor and a short cervix: a randomized controlled trial.

BACKGROUND: To date, no intervention has proved effective in reducing the spontaneous preterm birth rate in singleton pregnancies following an episode of threatened preterm labor and short cervix remaining. OBJECTIVE: This study was designed to ascertain whether cervical pessaries could be useful in preventing spontaneous preterm birth in women with singleton pregnancies and a short cervix after a threatened preterm labor episode. STUDY DESIGN: This open randomized controlled trial was conducted in 357 pregnant women (between 240-336 weeks) who had not delivered 48 hours after a threatened preterm labor episode and had a short cervix remaining (≤25 mm at 240-296 weeks; ≤15 mm at 300-336 weeks). Patients were randomly assigned to cervical pessary (179) or routine management (178). The primary outcome was the spontaneous preterm birth rate <34 weeks. Spontaneous preterm birth <28 and 37 weeks and neonatal morbidity and mortality were also evaluated in an intention-to-treat analysis. RESULTS: No significant differences between the pessary and routine management groups were observed in the spontaneous preterm birth rate <34 weeks (19/177 [10.7%] in the pessary group vs 24/175 [13.7%] in the control group; relative risk, 0.78; 95% confidence interval, 0.45-1.38). Spontaneous preterm birth <37 weeks occurred less frequently in the pessary group (26/175 [14.7%] vs 44/175 [25.1%]; relative risk, 0.58; 95% confidence interval, 0.38-0.90; P = .01). Preterm premature rupture of membranes rate was significantly lower in pessary carriers (4/177 [2.3%] vs 14/175 [8.0%]; relative risk, 0.28; 95% confidence interval, 0.09-0.84; P = .01). The pessary group less frequently required readmission for new threatened preterm labor episodes (8/177 [4.5%] vs 35/175 [20.0%]; relative risk, 0.23; 95% confidence interval, 0.11-0.47; P < .0001). No serious adverse maternal events occurred; neonatal morbidity and mortality were similar in both groups. CONCLUSION: Pessary use did not significantly lower the spontaneous preterm birth rate <34 weeks in women with a short cervix remaining after a threatened preterm labor episode but did significantly reduce the spontaneous preterm birth rate <37 weeks, threatened preterm labor recurrence, and the preterm premature rupture of membranes rate.

Cervical pessary placement for prevention of preterm birth in unselected twin pregnancies: a randomized controlled trial.

BACKGROUND: Preterm birth is the leading cause of neonatal death and handicap in survivors. Although twins are found in 1.5% of pregnancies they account for about 25% of preterm births. Randomized controlled trials in singleton pregnancies reported that the prophylactic use of progestogens, cervical cerclage and cervical pessary reduce significantly the rate of early preterm birth. In twin pregnancies, progestogens and cervical cerclage have been shown to be ineffective in reducing preterm birth. OBJECTIVE: The objective of this study was to test the hypothesis that the insertion of a cervical pessary in twin pregnancies would reduce the rate of spontaneous early preterm birth. STUDY DESIGN: This was a multicenter, randomized controlled trial in unselected twin pregnancies of cervical pessary placement from 20(+0)-24(+6) weeks' gestation until elective removal or delivery vs. expectant management. Primary outcome was spontaneous birth <34 weeks. Secondary outcomes included perinatal death and a composite of adverse neonatal outcomes (intraventricular haemorrhage, respiratory distress syndrome, retinopathy of prematurity or necrotizing enterocolitis) or need for neonatal therapy (ventilation, phototherapy, treatment for proven or suspected sepsis, or blood transfusion). Analysis was by intention to treat. This trial is registered in the ISRCTN registry, number 01096902. RESULTS: A total of 1,180 (56.0%) of the 2,107 eligible women agreed to take part in the trial; 590 received cervical pessary and 590 had expectant management. Two of the former and one of the latter were lost to follow up. There were no significant differences between the pessary and control groups in rates of spontaneous birth <34 weeks (13.6% vs. 12.9%; relative risk 1.054, 95% confidence interval [CI] 0.787-1.413; p=0.722), perinatal death (2.5% vs. 2.7%; relative risk 0.908, 95% CI 0.553-1.491; p=0.702), adverse neonatal outcome (10.0 vs. 9.2%; relative risk 1.094, 95% CI 0.851-1.407; p=0.524) or neonatal therapy (17.9% vs. 17.2%; relative risk 1.040, 95% CI 0.871-1.242; p=0.701). A post hoc subgroup analysis of 214 women with short cervix (≤25 mm) showed no benefit from the insertion of a cervical pessary. CONCLUSION: In women with twin pregnancy, routine treatment with cervical pessary does not reduce the rate of spontaneous early preterm birth.

Rationale and design of SuPPoRT: a multi-centre randomised controlled trial to compare three treatments: cervical cerclage, cervical pessary and vaginal progesterone, for the prevention of preterm birth in women who develop a short cervix.

BACKGROUND: Clinically, once a woman has been identified as being at risk of spontaneous preterm birth (sPTB) due to a short cervical length, a decision regarding prophylactic treatment must be made. Three interventions have the potential to improve outcomes: cervical cerclage (stitch), vaginal progesterone and cervical pessary. Each has been shown to have similar benefit in reduction of sPTB, but there have been no randomised control trials (RCTs) to compare them. METHODS: This open label multi-centre UK RCT trial, will evaluate whether the three interventions are equally efficacious to prevent premature birth in women who develop a short cervix (<25 mm on transvaginal ultrasound). Participants will be asymptomatic and between 14+0 and 23+6 weeks' gestation in singleton pregnancies. Eligible women will be randomised to cervical cerclage, Arabin pessary or vaginal progesterone (200 mg once daily) (n = 170 women per group). The obstetric endpoints are premature birth rate <37 weeks' of gestation (primary), 34 weeks and 30 weeks (secondary outcomes) and short-term neonatal outcomes (a composite of death and major morbidity). It will also explore whether intervention success can be predicted by pre-intervention biomarker status. DISCUSSION: Preterm birth is the leading cause of perinatal morbidity and mortality and a short cervix is a useful way of identifying those most at risk. However, best management of these women has presented a clinical conundrum for decades. Given the promise offered by cerclage, Arabin pessary and vaginal progesterone for prevention of preterm birth in individual trials, direct comparison of these prophylactic interventions is now essential to establish whether one treatment is superior. If, as we hypothesise, the three interventions are equally efficacious, this study will empower women to make a choice of treatments based on personal preference and quality of life issues also explored by the study. Our exploratory analysis into whether the response to intervention is related to the pre-intervention biomarker status further our understanding of the pathophysiology of spontaneous preterm birth and help focus future research questions. TRIAL REGISTRATION: EudraCT Number: 2015-000456-15 . Registered 11th March 2015.

Arabin cervical pessary in women at high risk of preterm birth: a magnetic resonance imaging observational follow-up study.

OBJECTIVE: To help elucidate the mechanism of action of the Arabin cervical pessary in pregnancies at high risk for preterm delivery. METHODS: Cervical length and uterocervical angle were evaluated in relation to gestational age in 198 pregnancies not at high risk for preterm birth that underwent clinical fetal magnetic resonance imaging (MRI). Additionally, in 73 singleton pregnancies at high risk for preterm birth, an Arabin cervical pessary was placed at 14-33 weeks' gestation. We performed MRI of the cervix immediately before and after placement and at monthly follow-up until removal of the pessary. In a subgroup of 54 pregnancies with a short cervix and pessary placement at 17-31 weeks' gestation, the uterocervical angle and cervical length at follow-up were compared with the preplacement values. RESULTS: In pregnancies not at high risk for preterm birth, the uterocervical angle did not vary, but cervical length showed a significant decrease with gestational age (r = -0.15, P < 0.05). Among the high-risk patients, the cervical pessary was successfully placed at first attempt in 60 (82.2%) and by the second attempt in 66 (90.4%), remaining well positioned until removal. In five patients we failed to place the pessary after two attempts, in one patient the pessary dislodged during follow-up and in one case the pessary was partly placed in the external cervical canal and triggered labor the next day. Among the subgroup of 54 patients, the median uterocervical angle immediately after pessary placement was significantly more acute than that prior to placement in the 46 (85.2%) who delivered after 34 weeks (132° vs 146°, P < 0.01), but was unchanged in the eight patients who delivered before 34 weeks (143° vs 152°, P > 0.05). CONCLUSION: In patients at high risk for preterm delivery, correct placement of the Arabin cervical pessary should be checked immediately; this can be performed quickly and easily using MRI. This study provides some evidence that, in singleton pregnancies with a short cervix, a cervical pessary delays birth through a mechanical effect on the uterocervical angle.

Use of an Arabin pessary to prevent preterm birth in pregnancy complicated by a short cervix after cervical conization for cervical adenocarcinoma with residual disease: A case report and literature review.

Surgical conization of the cervix for cervical cancer increases the risk of preterm birth in subsequent pregnancies. The ideal intervention to prevent preterm births in women with cervical insufficiency resulting from conization is not known. When histological margins of the cone biopsy are suspected to have residual malignancy, surveillance and oncological management during a concurrent pregnancy can be challenging. This case outlines the management of a pregnancy complicated by a short cervix secondary to conization for adenocarcinoma of cervix, with margins suspected to be not clear of disease. The patient had progressive shortening of the cervix despite vaginal progesterone, but maintained a cervical length of 16 mm following Arabin pessary insertion. She delivered a healthy neonate at 34 + 3 weeks of gestation (105 days following pessary insertion). The cervical pessary in combination with vaginal progesterone may be safe and effective in preventing preterm birth in a pregnancy with possible residual cervical cancer and a short cervix.

Pregnancy outcomes in women with large uterine fibroids.

STUDY AIM: To evaluate the effects of the combination of Arabin pessary or cervical cerclage with vaginal micronised progesterone versus micronised progesterone or no medical management on the outcomes of pregnancies in women with large uterine fibroids. MATERIALS AND METHODS: This was a retrospective, observational, controlled study in 120 women aged 18-45 years with large uterine (≥8 cm) fibroids diagnosed in the first trimester, who underwent treatment in the regional perinatal center of the Omsk Regional Clinical Hospital between 2015 and 2019. Women in Group A (n = 90) were divided into two subgroups. In Subgroup А1 (n = 35), participants received the combination of a cervical procedure (Arabin pessary or cerclage) and micronised progesterone, and in Subgroup А2 (n = 55) all participants additionally underwent myomectomy. In Group B (n = 18), only micronised progesterone was used. In Group C (n = 12), no medical therapy was administered during pregnancy. RESULTS: Large uterine fibroids in pregnancy were associated with a threatened pregnancy loss in 46.4% of women and pain in almost 40% of women. Myomectomy in pregnancy was performed in 55 women. The combination of Arabin pessary or cervical cerclage with micronized progesterone reduced the rates of preterm delivery by 2.2-fold versus the progesterone-only group and by 11.2-fold versus no medical management group (χ2 = 19.4; p = .0001). CONCLUSION: The combination of Arabin pessary or cervical cerclage with micronized progesterone in our study helped achieve term deliveries in >90% of pregnant women with large fibroids.

The use of fetal fibronectin and cervical length measurements in the prediction of spontaneous preterm birth in women with an Arabin pessary in situ.

OBJECTIVES: The ability to predict spontaneous PTB (sPTB) has improved greatly, allowing women at risk to be managed with prophylactic interventions such as cervical cerclage and the Arabin pessary. Cervicovaginal fetal fibronectin (qfFN) concentration and ultrasound measurement of cervical length (CL) are the two most established tools to predict sPTB. There is however limited data regarding the predictive value of qfFN and CL tests following insertion of an Arabin pessary. Our aim was therefore to determine the clinical use of qfFN and CL measurements to predict sPTB in women fitted with an Arabin pessary. STUDY DESIGN: This study is a secondary analysis on the SUPPORT trial data. Data were prospectively collected from women attending high-risk preterm surveillance clinics in 3 London centres between July 2015 and April 2020. The matched control group was pregnant women attending the same high-risk preterm surveillance clinics who had not received an Arabin pessary. Receiver operating characteristic (ROC) curves for prediction of birth by 34 and by 37 weeks' gestation were generated for qfFN and CL measurements combined for both study groups. A formal comparison of area under the curve before 34 weeks' gestation (AUC < 34 weeks) was made between the two study groups. RESULTS: At our primary endpoint of sPTB < 34 weeks' gestation, qfFN was a good predictor of sPTB in cases with an Arabin pessary in situ (AUC, 0.79, 95% CI: 0.62-0.90) and no worse than the control group who did not have an Arabin pessary, (AUC 0.74, 95% CI: 0.48-0.96). CL had good prediction for sPTB < 34 weeks' gestation in the control group (AUC 0.76, 95% CI: 0.63-0.88) but was lower and non-significant in the Arabin pessary case group (AUC 0.60, 95% CI: 0.43-0.76). CONCLUSIONS: This study showed that cervicovaginal qfFN concentration is equally reliable in the prediction of sPTB in pregnant women at increased risk of sPTB with and without an Arabin pessary in situ, and significantly better than CL measurement alone for predicting delivery before 34 weeks. This commonly used test therefore has utility in predicting sPTB in pregnant women fitted with an Arabin pessary.

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.

The impact of funneling shape on the secondary prevention of spontaneous preterm birth in patients treated with either an Arabin pessary, McDonald cerclage or early total cervical occlusion (ETCO).

OBJECTIVE: Cervical funneling is associated with spontaneous preterm birth (sPTB). The aim of this analysis was to assess the relationship between funneling shape and the response to the McDonald cerclage, the Arabin pessary and the early total cervical occlusion (ETCO). METHODS: We retrospectively analyzed data of 312 randomly selected singleton pregnancies with cervical shortening <25 mm or normal cervical length and evaluated them according to the progression of funneling: control group (n = 46), cervical shortening without funneling (n = 107), V-shaped funneling (n = 68), U-shaped funneling (n = 47), and prolapse of the amniotic sac (n = 44). We evaluated sPTB rates <34, <28, <32, and <37 weeks as well as prolongation of gestation and birthweight. RESULTS: Regarding the rate of sPTB <34 weeks there was no statistical significance in either of the comparisons between control group and each of the four risk groups. Regarding prolongation of gestation we demonstrated a statistical significance for all risk groups compared to the control group (all p < .05) with the lowest prolongation rate noted in the group with amnion prolapse and the highest in the group with isolated cervical shortening without funneling. Similarly, progression of funnel shape resulted in an absolute decrease of birthweight for all risk groups compared to the control group, albeit not significant for the group with U-shaped funneling (p = .1058). CONCLUSION: Independent of the treatment, there was a significant impact of funneling shape on pregnancy duration and birthweight.

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.

Is the Arabin Pessary really useful in preventing preterm birth? A review of literature.

The aim of this review is to describe the state of the art in the use of Arabin Pessary for the prevention of spontaneous preterm birth (SPTB). We conducted a review of the literature in order to collect relevant studies concerning the efficacy of Arabin Pessary in preventing preterm birth, also considering it in addition or in comparison with other methods such as cervical cerclage or vaginal progesterone and in both singleton and twin pregnancy. Despite the large number of studies available there is not a clear consensus about the superiority of one of this methods over the others. In addition to this, although Arabin Pessary is widely used in clinical practice, no guidelines for management and use of cervical pessary during pregnancy have been assessed.

The impact of a short cervix and funneling on the outcome in singleton pregnancies treated with an Arabin-pessary or a McDonald cerclage.

OBJECTIVE: The presence of sonographic funneling is a co-predictor of spontaneous preterm birth (sPTB). The aim of this study was to assess the outcome in patients with a short cervix and funneling after a McDonald cerclage or an Arabin pessary. METHODS: We retrospectively analyzed data of 238 singleton pregnancies with cervical shortening <25 mm subclassified by either isolated cervical shortening (n = 105) or cervical shortening and additional funneling (n = 133). In the group of isolated cervical shortening, a total of 93 patients had received a cervical pessary and 12 had McDonald cerclage. In the group of patients with additional funneling, 98 had received a cervical pessary and 35 had a cerclage. We evaluated PTB rates <28, <32, <34, and <37 weeks as well as prolongation of gestation, birth weight, and admission to NICU. RESULTS: In the pessary groups (n = 191), funneling resulted in a significantly higher rate of PTB before 34 weeks as compared to patients with isolated cervical shortening (26.5 versus 8.6%, p=.0066). Similarly, in the cerclage groups (n = 47), funneling resulted in an absolute increase of PTB, albeit not significant (37.1 versus 0%, p=.1435) due to the smaller number. There were no significant differences in terms of prevention of PTB before 34 weeks in patients treated with pessary or cerclage, neither in the group of patients with isolated shortening nor in the group of patients with additional funneling (p=.9771 and p=.3916, respectively). However, in patients with funneling, we demonstrated a significantly lower neonatal admission rate in the pessary arm (n = 27, 27.6%) as compared to the cerclage arm (n = 31, 88.6%) (p = .0002). Similarly, the NICU admission time was shorter in both pessary groups -with and without funneling - as compared to patients treated with cerclage (p = .0000). CONCLUSION: Pessary placement and cerclage should optimally be considered before the presence of funneling. Furthermore, there were lower rates of neonatal admission during pregnancy and a shorter admission time of babies after birth when mothers received a cervical pessary as compared to the group with cervical cerclage.

Combined treatment of McDonald cerclage and Arabin-pessary: a chance in the prevention of spontaneous preterm birth?

Background: Patients with cervical shortening obtained by transvaginal ultrasound and/or previous preterm delivery are at increased risk for preterm birth in the current pregnancy. The aim of the present cohort study was to compare the rate of preterm birth and early neonatal parameters in patients at risk and screening patients who received either a cerclage or a combined treatment of cerclage and cervical pessary.Methods: A retrospective cohort study was conducted from March 2005 to March 2017 including all patients in our department which received a McDonald cerclage or a combined treatment of McDonald cerclage and an Arabin pessary. A total of 81 women with singleton pregnancies were considered the final sample of this cohort study, of whom 34 patients received a cerclage and 47 patients received a cerclage combined with a pessary. Patients "at risk" with a history of preterm birth at <37 weeks of gestation, late-term abortion, conization, or cervical cerclage in a previous pregnancy because of a cervical shortening <10th percentile and women with no inherent historic risk factors but a current cervical length <3rd percentile (screening group) were analyzed separately. We defined delivery <34 weeks of gestation as the primary outcome. Secondary outcomes were preterm birth (PTB) <28, <32, and <37 weeks of gestation, admission to the neonatal intensive care unit (NICU), neonatal admission time, birthweight, and prolongation of the gestation.Results: There were no differences between the two study groups with regard to baseline characteristics. Delivery <34 weeks of gestation occurred in 32.4 and 27.7% of patients treated with cerclage versus combined treatment respectively (p = .48). Similarly, there was no difference in the rate of preterm birth at <28, <32, or <37 weeks of gestation. The mean neonatal admission time at the neonatal intensive care unit was shorter in the combined treatment group versus in the cerclage group (p = .02). There was a trend for higher birthweight (2368 g ± 962 vs. 2650 g ± 1063) in favor of the combined treatment arm (p = .077).Conclusion: The combined treatment of cerclage with an Arabin pessary seems to be a considerable alternative in the prevention of spontaneous PTB (sPTB), especially for patients with cervical length <3rd percentile, and in particular for patients with amnion prolapse in terms of birthweight and neonatal admission time.

Position Paper of the Task Force for Obstetrics and Prenatal Medicine (AGG - Section Preterm Birth) on the Placement, Removal and Surveillance of the Arabin Cervical Pessary in Patients at Risk for Spontaneous Preterm Birth.

This position paper describes clinically important, practical aspects of cervical pessary treatment. Transvaginal ultrasound is standard for the assessment of cervical length and selection of patients who may benefit from pessary treatment. Similar to other treatment modalities, the clinical use and placement of pessaries requires regular training. This training is essential for proper pessary placement in patients in emergency situations to prevent preterm delivery and optimize neonatal outcomes. Consequently, pessaries should only be applied by healthcare professionals who are not only familiar with the clinical implications of preterm birth as a syndrome but are also trained in the practical application of the devices. The following statements on the clinical use of pessary application and its removal serve as an addendum to the recently published German S2-consensus guideline on the prevention and treatment of preterm birth.

Comparative Evaluation of Arabin Pessary and Cervical Cerclage for the Prevention of Preterm Labor in Asymptomatic Women with High Risk Factors.

OBJECTIVE: Preterm labor is one of the most significant obstetric problems associated with high rate of actual and long-term perinatal complications. Despite the creation of scoring systems, uterine activity monitoring, cervical ultrasound and several biochemical markers, the prediction and prevention of preterm labor is still a matter of concern. The aim of this study was to examine cervical findings for the prediction and the comparative use of Arabin pessary or cerclage for the prevention of preterm birth in asymptomatic women with high risk factors for preterm labor. MATERIAL AND METHODS: The study group was composed of singleton pregnancies (spontaneously conceived) with high risk factors for preterm labor. Cervical length, dilatation of the internal cervical os and funneling, were estimated with transvaginal ultrasound during the first and the second trimesters of pregnancy. RESULTS: Cervical funneling, during the second trimester of pregnancy, was the most significant factor for the prediction of preterm labor. The use of Arabin cervical pessary was found to be more effective than cerclage in the prolongation of pregnancy. CONCLUSION: In women at risk for preterm labor, the detection of cervical funneling in the second trimester of pregnancy may help to predict preterm labor and to apply the appropriate treatment for its prevention. Although the use of cervical pessary was found to be more effective than cerclage, more studies are needed to classify the effectiveness of different methods for such prevention.

Spontaneous preterm birth prevention in multiple pregnancy.

KEY CONTENT: Twin pregnancies are associated with a three-fold greater perinatal mortality than singleton pregnancies. Prematurity is a main contributor, with 50% of twin pregnancies delivering before 37 weeks and 10% delivering before 32 weeks of gestation.The aetiology of preterm delivery in twin pregnancies is likely multifactorial and different from that of singletons.Cervical cerclage reduces preterm birth rates in singletons but has mixed results in twins with some studies showing harm.The use of progesterone to prevent preterm birth in singletons has conflicting results and has not been proven to prevent preterm birth in twins. Studies continue to determine whether the cervical pessary is effective in preventing preterm birth in multiple pregnancies.There is a paucity of data available on the prevention of preterm birth in triplets/higher order multiples but similar principles to twin pregnancy apply. LEARNING OBJECTIVES: To review the burden of preterm birth in multiple pregnancy.To understand the methods available for preventing preterm birth in multiple pregnancies and the evidence surrounding the use of each one.To be aware of the use of the Arabin pessary.