Arabin Cervical Pessary Research Articles

Cervical pessary versus vaginal progesterone in women with a singleton pregnancy, a short cervix, and no history of spontaneous preterm birth at less than 34 weeks’ gestation: open label, multicentre, randomised, controlled trial

ObjectiveTo compare the effectiveness of cervical pessary and vaginal progesterone in the prevention of adverse perinatal outcomes and preterm birth in pregnant women of singletons with no prior spontaneous preterm...

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.

Microbiological safety of the Dr. Arabin cervical pessary in pregnant women with short cervix

BACKGROUND: The insertion of a cervical pessary is a method for treating short cervix and preventing preterm birth. The study of the vaginal microbiota composition and the need for its routine correction after the pessary insertion remain to be investigated. To date, there are no works devoted to the assessment of changes in vaginal microbiocenosis after the cervical pessary insertion.
 AIM: The aim of this study was to assess the microbiological safety of the Dr. Arabin cervical pessary in pregnant women with short cervix.
 MATERIALS AND METHODS: This prospective study included 22 pregnant women with singleton or multiple pregnancies with short cervix (25 L.J. Salomon scale) and threatened miscarriage in the second and third trimesters who received the Dr. Arabin cervical pessary. The obtained clinical materials included the secretion of the posterolateral vaginal fornix. We used the Femoflor 16 test (NPO DNA-Technology Ltd., Moscow, Russia) as a method of molecular biological analysis. In addition, the patients independently controlled the pH of the vaginal contents using the pH-balance express test. Vaginal microbiocenosis was assessed in a dynamic manner: before the cervical pessary insertion, then every two to four weeks after it, and on the day the pessary was removed. In all 22 pregnant women, clinical material was obtained twice: before the cervical pessary was inserted and when it was removed; in 15 women (68.18%) three times, and in nine pregnant women (40.91%) four times.
 RESULTS: The analysis of vaginal microbiocenosis showed no significant changes in vaginal microbiocenosis in the examined pregnant women before and after the insertion of the cervical pessary (p 0.05). The concentration of lactobacilli remained high (in the range of 107 lg DNA copies/ml) during the entire observation period. The numbers of facultative and obligate anaerobic bacteria, as well as yeast-like fungi of the Candida genus, Ureaplasma spp., and Mycoplasma hominis were within the physiological levels. No pathogenic microorganisms such as Mycoplasma genitalium were detected in any patient. After the cervical pessary insertion against the background of normocenosis, 72.73% of pregnant women noted an increase in the amount of light and odorless discharge from their genital tract. However, we found no changes in the vaginal microbiota composition.
 CONCLUSIONS: The insertion of the Dr. Arabin cervical pessary under conditions of vaginal normocenosis is a microbiologically safe way to correct short cervix and prevent preterm birth, and does not disrupt the vaginal microflora in pregnant women before delivery.

The effectiveness of the Dr. Arabin cervical pessary in the prevention of extreme preterm birth and very preterm birth in twins

BACKGROUND: Multiple pregnancy remains a serious obstetrical problem, as it is a high risk factor for miscarriage/preterm birth at any gestational age. On average, in 54% of patients with twins, pregnancy ends in preterm birth, regardless of the economic situation and the level of perinatal care in the state, and is characterized by high childhood morbidity and mortality.
 AIM: The aim of this study was to identify risk factors for spontaneous preterm birth and to evaluate the effectiveness of a cervical pessary in pregnant women with twins and a short cervix.
 MATERIALS AND METHODS: This prospective, open, randomized cohort study included 91 women with twins, a short cervix (25 according to the L.J. Salomon scale) and a threatened miscarriage / preterm birth in the second and third trimesters of pregnancy, who received the Dr. Arabin cervical pessary. We analyzed pregnancy outcomes and identified risk factors for spontaneous preterm birth.
 RESULTS: Based on the pregnancy outcomes, all patients were categorized into two main groups after 16 pregnant women with induced preterm birth were excluded from further study. The study was continued by 75 pregnant women, with term birth in 40 (53.3%) women in group I and spontaneous preterm birth in 35 (46.7%) women in group II.
 The average period of pregnancy prolongation was statistically different between groups II and I (8.86 4.86 and 12.32 4.38 weeks, p 0.01). The average gestational age of labor initiation was 37.73 0.62 weeks in group I and 34.24 2.08 weeks in group II (p 0.001). We found no extreme preterm birth (22-27 6/7 weeks) in group II, the perinatal mortality of newborns being the highest at this gestational age. Labor at a gestational age of 28-33 6/7 weeks was in 14 (18.67%) women and of 34-36 6/7 weeks in 21 (28.00%) women. The detailed analysis of the course and outcomes of pregnancy and labor in high-risk groups identified two factors that affect the occurrence of spontaneous preterm birth in twin pregnancies: the Bishop score 5 points (p = 0.03579; odds ratio 4.93, 95% confidence interval 1.2319.74) and cervical length on bimanual vaginal examination 20 mm (p = 0.014; odds ratio 4.67, 95% confidence interval 1.4714.82).
 CONCLUSIONS: The use of a cervical pessary in the group of pregnant women with twins and at a high risk of spontaneous preterm birth not only allows for prolonging pregnancy and excluding the birth of extremely premature babies, but also reduces the number of spontaneous extreme and very preterm births.

Assessment of the risk of spontaneous preterm birth in pregnant women with the Dr. Arabin cervical pessary

BACKGROUND: Preterm birth has a multifactorial etiology, including both maternal and fetal complications, amid the effect of functionally impaired variants of multiple genes. Preterm birth is therefore considered as the major obstetric syndrome. One of the anatomical components of this syndrome is a short cervix, and a cervical pessary is used as a prevention of preterm birth in these patients.
 AIM: The aim of this study was to identify risk factors for spontaneous preterm birth in pregnant women who received a cervical pessary.
 MATERIALS AND METHODS: This prospective, open, randomized cohort study included 189 women with a singleton pregnancy and a short cervix (25 according to the Salomon scale) and a threatened miscarriage / preterm birth in the second and third trimesters trimester, who received the Dr. Arabin cervical pessary. We analyzed 183 parameters and identified the main risk factors leading to spontaneous preterm birth based on pregnancy outcomes.
 RESULTS: Based on the pregnancy outcomes, all patients were categorized into two main groups: group I included 167 women with term birth and group II consisted of 19 pregnant women with spontaneous preterm birth. The main risk factors for spontaneous preterm birth in singleton pregnancies in descending order were: the Bishop score 7 points (p = 0.00032, OR 12.38, 95 % CI [3.5043.87]), the modified Steinberg score 8 points (p = 0.00056, OR 10.55, 95% CI [3.0936.03]), cervical length 15 mm by transvaginal cervicometry (p 0.001, OR 7.94, 95% CI [2.8322.26]), history of preterm birth (p = 0.00128, OR 6.91, 95% CI [2.3220.56]), chronic placental insufficiency (p = 0.00307, OR 5.06, 95 % CI [1.8214.01]), genital anomalies (p = 0.07452, OR 5.03, 95% CI [1.1522.06]), and history of surgical manipulations on the cervix (p = 0.07003, OR 2.90, 95% CI [1.058.00]). In multivariate analysis, the risk of spontaneous preterm birth was five times higher in pregnant women with the concomitant presence of three risk factors: cervical length 15 mm, the modified Steinberg score 8 points, and the Bishop score 7 points (83.33% of spontaneous preterm birth compared to 16.67% of term birth; p 0.05, OR 59.29, 95% CI [6.47543.29]).
 CONCLUSIONS: Among patients with a short cervix and the Dr. Arabin cervical pessary, we have identified groups at higher risk for spontaneous preterm birth.

Patient's experience with the Arabin cervical pessary during pregnancy: A questionnaire survey.

The cervical pessary is used in women with precocious cervical ripening to prevent preterm birth. Up to now however, there have been no systematic studies on compliance and tolerance, which vary among different study cohorts. A questionnaire was administered to 166 women treated with the Arabin cervical pessary in one center. Data were analysed about the patient's experience before insertion (adequacy of information received), during treatment (follow-up, impact on daily life, perceived discomfort, side effects) and at the time of removal (pain, if the patient's expectations had been met regarding the treatment). Information received before the insertion of the Arabin cervical pessary was considered adequate in 163/166 (98.2%) women. An increase in vaginal discharge was experienced by 70/166 (42.2%) women. Discomfort or other side effects were reported in 13.8% and 16.3% of cases, respectively. Overall, 77% of women reported an improved quality of life and 94% considered the follow-up during pregnancy adequate. Removal was moderately painful for 58/166 (35%) of women. Patient's expectations regarding the treatment were exceeded in the majority of cases (75.3%). In a final step, we compared our results to previous studies regarding the use of the pessary in singleton and twin pregnancies. Although some trials report high rates of non-compliant patients, this could not be confirmed by our study. In contrast, most women reported having a positive experience and that they were motivated to continue the treatment when they were continuously followed by experienced clinicians.

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.

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. 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. 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. Antenatal clinics in the UK and elsewhere in Europe. Women with twin pregnancy at < 21 weeks' gestation with known chorionicity and gestation established by scan at ≤ 16 weeks' gestation. 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. 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. 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. There was the possibility of a type II error around smaller than anticipated benefit. 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. Women with twin pregnancy remain at risk of preterm birth; work is required to find treatments for this. Current Controlled Trials ISRCTN98835694 and ClinicalTrials.gov NCT02235181. 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.

Evaluation of the Arabin cervical pessary for prevention of preterm birth in women with a twin pregnancy and short cervix (STOPPIT-2): An open-label randomised trial and updated meta-analysis.

BackgroundPreterm-labour-associated preterm birth is a common cause of perinatal mortality and morbidity in twin pregnancy. We aimed to test the hypothesis that the Arabin pessary would reduce preterm-labour-associated preterm birth by 40% or greater in women with a twin pregnancy and a short cervix.Methods and findingsWe conducted an open-label randomised controlled trial in 57 hospital antenatal clinics in the UK and Europe. From 1 April 2015 to 14 February 2019, 2,228 women with a twin pregnancy underwent cervical length screening between 18 weeks 0 days and 20 weeks 6 days of gestation. In total, 503 women with cervical length ≤ 35 mm were randomly assigned to pessary in addition to standard care (n = 250, mean age 32.4 years, mean cervical length 29 mm, with pessary inserted in 230 women [92.0%]) or standard care alone (n = 253, mean age 32.7 years, mean cervical length 30 mm). The pessary was inserted before 21 completed weeks of gestation and removed at between 35 and 36 weeks or before birth if earlier. The primary obstetric outcome, spontaneous onset of labour and birth before 34 weeks 0 days of gestation, was present in 46/250 (18.4%) in the pessary group compared to 52/253 (20.6%) following standard care alone (adjusted odds ratio [aOR] 0.87 [95% CI 0.55–1.38], p = 0.54). The primary neonatal outcome—a composite of any of stillbirth, neonatal death, periventricular leukomalacia, early respiratory morbidity, intraventricular haemorrhage, necrotising enterocolitis, or proven sepsis, from birth to 28 days after the expected date of delivery—was present in 67/500 infants (13.4%) in the pessary group compared to 76/506 (15.0%) following standard care alone (aOR 0.86 [95% CI 0.54–1.36], p = 0.50). The positive and negative likelihood ratios of a short cervix (≤35 mm) to predict preterm birth before 34 weeks were 2.14 and 0.83, respectively. A meta-analysis of data from existing publications (4 studies, 313 women) and from STOPPIT-2 indicated that a cervical pessary does not reduce preterm birth before 34 weeks in women with a short cervix (risk ratio 0.74 [95% CI 0.50–1.11], p = 0.15). No women died in either arm of the study; 4.4% of babies in the Arabin pessary group and 5.5% of babies in the standard treatment group died in utero or in the neonatal period (p = 0.53). Study limitations include lack of power to exclude a smaller than 40% reduction in preterm labour associated preterm birth, and to be conclusive about subgroup analyses.ConclusionsThese results led us to reject our hypothesis that the Arabin pessary would reduce the risk of the primary outcome by 40%. Smaller treatment effects cannot be ruled out.Trial registrationISRCTN Registry ISRCTN 02235181.ClinicalTrials.gov NCT02235181.

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.

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.

The role of cervical pessary and progesterone therapy in the phenomenon of placenta previa migration

Objective: This study aimed to evaluate the effects of combined management of placenta previa with the Arabin cervical pessary and progesterone.Study design: In this randomized controlled study, we followed up 217 patients with placenta previa and high risk of preterm birth. The main group (n = 81) underwent combined management with the Arabin cervical pessary and progesterone; the control group (n = 136) received progesterone only. Placental migration was monitored using Doppler scanning from 24 weeks of pregnancy onwards.Results: Patients receiving the combination of the Arabin cervical pessary and progesterone had a three-fold reduced rate of bleeding during pregnancy compared with patients in the control group (11.3% versus 33.1%; p = .006). Placental migration occurred 1.8 times more often in the pessary group (48.1% versus 26.4%; p = .037), and preterm labor <34 weeks occurred 2.7 times less often compared with the control group (p = .031). The use of the Arabin cervical pessary caused a change in the anterior cervico-uterine angle by 7.4 degrees, and reduction in the arcuate artery RI at 32−33 weeks of pregnancy compared with the control group.Conclusions: The use of the Arabin cervical pessary combined with progesterone in patients with placenta previa significantly reduced the rate of preterm delivery <34 weeks and bleeding during pregnancy.

Arabin cervical pessary with vaginal progesterone versus vaginal progesterone for preventing preterm delivery

Purpose: To compare the rate of preterm delivery in pregnant women with a short cervical length managed with Arabin cervical pessary and vaginal progesterone versus vaginal progesterone alone.Methods: This was a retrospective cohort study of singletons pregnancies managed in two tertiary medical centers between September 2011 and May 2017. One center utilized the combined treatment of Arabin cervical pessary and vaginal progesterone (study group) and the second utilized vaginal progesterone approach (control group).Results: During the study period, a total of 202 pregnant women who underwent vaginal ultrasonography between 15 and 29 weeks gestation. They all had short cervical length (≤25 mm). Among them, 94 (46.5%) and 108 (53.5%) patients were in the study and control group, respectively. A significantly higher rate of patients in the study group had either a history of cervical incompetence (9.6 vs. 0.9%, respectively, p = 0.006) or cervical surgery (7.9 vs. 0%, respectively, p = .003). Despite having shorter cervical length at recruitment (14.3 ± 5.9 vs. 16.9 ± 5.7, respectively, p = .002) the rate of spontaneous delivery < 34-week gestation was lower in the study group (7.4 vs. 17.6%, respectively, p = .036) and they delivered 1-week later compared to the control group (37.2 ± 2.1 vs. 36.2 ± 3.7, respectively, p = 0.02).Conclusion: We found that for pregnant women with singletons and who had a short cervical length, the combined treatment of Arabin cervical pessary and vaginal progesterone had lower rate of preterm delivery < 34 weeks of gestation and prolonged gestation compared to those women who were treated with vaginal progesterone alone. Our preliminary findings warrant randomized control studies in order to further illuminate our results.

337: Arabin cervical pessary with vaginal progesterone versus vaginal progesterone for preventing preterm delivery

Preterm birth is the leading cause of perinatal morbidity and mortality. Vaginal progesterone and Arabin cervical pessary are both considered as preventive treatments in women at risk for preterm birth. However, there is little evidence as to which of these two interventions is the preferred management. The objective was to compare the rate of preterm delivery in pregnant women with a short cervical length managed with Arabin cervical pessary and vaginal progesterone versus vaginal progesterone alone This was a retrospective cohort study of singletons pregnancies managed in two tertiary medical centers between September 2011 and May 2017. One center utilized the combined treatment of Arabin cervical pessary and vaginal progesterone (study group) and the second utilized vaginal progesterone approach (control group). During the study period, a total of 202 pregnant women who underwent vaginal ultrasonography between 15-29 weeks gestation. They all had short cervical length (≤25 mm). Among them 94 (46.5%) and 108 (53.5%) patients were in the study and control group respectively. A significantly higher rate of patients in the study group had either a history of cervical incompetence (9.6% vs 0.9% respectively, P=0.006) or cervical surgery (7.9% vs 0% respectively, P=0.003). Despite having shorter cervical length at recruitment (14.3±5.9 vs 16.9±5.7 respectively, P=0.002) the rate of spontaneous delivery<34 weeks gestation was lower in the study group (7.4% vs 17.6% respectively, P=0.036) and they delivered one week later compared to the control group (37.2±2.1 vs 36.2±3.7 respectively, P=0.02). We found that for pregnant women with singletons and who had a short cervical length, the combined treatment of Arabin cervical pessary and vaginal progesterone had lower rate of preterm delivery<34 weeks of gestation and prolonged gestation compared to those women who were treated with vaginal progesterone alone.

Open randomised trial of the (Arabin) pessary to prevent preterm birth in twin pregnancy with health economics and acceptability: STOPPIT-2—a study protocol

IntroductionThe STOPPIT-2 study aims to determine the clinical utility of the Arabin cervical pessary in preventing preterm birth in women with a twin pregnancy and a short cervix, about which...

Arabin cervical pessary for prevention of preterm birth in cases of twin-to-twin transfusion syndrome treated by fetoscopic LASER coagulation: the PECEP LASER randomised controlled trial

BackgroundFetoscopic LASER coagulation of the placental anastomoses has changed the prognosis of twin-twin transfusion syndrome. However, the prematurity rate in this cohort remains very high. To date, strategies proposed to decrease the prematurity rate have shown inconclusive, if not unfavourable results.MethodsThis is a randomised controlled trial to investigate whether a prophylactic cervical pessary will lower the incidence of preterm delivery in cases of twin-twin transfusion syndrome requiring fetoscopic LASER coagulation. Women eligible for the study will be randomised after surgery and allocated to either pessary or expectant management. The pessary will be left in place until 37 completed weeks or earlier if delivery occurs. The primary outcome is delivery before 32 completed weeks. Secondary outcomes are a composite of adverse neonatal outcome, fetal and neonatal death, maternal complications, preterm rupture of membranes and hospitalisation for threatened preterm labour. 352 women will be included in order to decrease the rate of preterm delivery before 32 weeks’ gestation from 40% to 26% with an alpha-error of 0.05 and 80% power.DiscussionThe trial aims at clarifying whether the cervical pessary prolongs the pregnancy in cases of twin-twin transfusion syndrome regardless of cervical length at the time of fetoscopy.Trial registrationClinicalTrials.gov Identifier: NCT01334489. Registered 04 December 2011.

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.

Modification of cervical length after cervical pessary insertion: correlation weeks of gestation

Objectives: To observe the modifications in cervical length (CL) in patients with and without cervical pessary (Arabin® ASQ 65/25/32) and correlate these modifications with gestational age at delivery.Study design: Prospective study of asymptomatic singleton pregnancies (PECEP-Trial) between weeks 20 + 0 and 23 + 6 with maternal short cervix (<25 mm) randomised into two groups: expectant management and cervical pessary.Results: This study included 380 pregnant women: 190 with pessary and 190 without pessary. Mean CL in both groups at the time of randomisation showed no statistically-significant differences (pessary group: 19.0 mm and management group: 19.0 mm; p = 0.9). Mean CL measured after randomisation was 15.4 mm in patients of the expectant management group and 21.5 mm in the pessary group. These differences were statistically significant (p < 0.0001). When means at randomisation and at the second measurement were compared, CL had decreased by 3.6 mm in the expectant management group and increased by 2.6 mm in the pessary group; this difference was statistically significant (p < 0.0001). Coefficients of correlation showed that among patients of both groups with the same CL at 20 weeks of gestation, those with a pessary gave birth later.Conclusions: Insertion of an Arabin cervical pessary increased CL in asymptomatic patients with a short cervix, which correlated with shorter gestational age at delivery. The cervical pessary halted the progressive decrease in CL, which correlated with longer gestational age at delivery.

Arabin cervical pessary to prevent preterm birth in twin pregnancies with short cervix

A retrospective study was conducted to evaluate the effect of Arabin cervical pessary in twin pregnancies with cervical length (CL) <25 mm between 21 and 31 weeks. Forty patients receiving pessary were matched with 40 controls without pessary. They were matched for gestational age (GA) at admission and CL. GA at delivery, delivery before 36, 34 and 32 weeks, latency between detection of short cervix and delivery, and duration of hospital admission were compared between groups. Women with the pessary delivered at higher GA compared to controls (35 vs. 33 weeks, p = 0.02). Cervical pessary significantly reduced the incidence of delivery <36 and < 34 weeks (p < 0.05), but not before 32 weeks. Interval between detection of short cervix and delivery was longer in the pessary group and duration of hospital admission was shorter (p = 0.03) compared to women without pessary.

ISUOG Practice Guidelines: role of ultrasound in twin pregnancy.

ISUOG Practice Guidelines: role of ultrasound in twin pregnancy.