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

Introduction 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. Material and methods 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). Results 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. Conclusion 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.

The importance of experience in using cervical pessary for prevention of preterm birth

Cervical pessary is a new treatment for preterm birth and have obtained a lot of space in clinical practice because its real efficacy, which unconsidered the bias produced by some research. There is a lack of evidence about cervical pessary in many aspects and only those who handle this device every day can note and call for attention. Experience is the central point about cervical pessary in this article, and important centers with training and expertise must be taken the front of this issue, because low experience probably is one of the causes of contradictory results in literature. In fact, we have a lot of aspects that need attention and never were treated because always the efficacy is questioned and do not open space for other important aspects. We have a lot of o issues to discuss during this article such as the indication of a cervical pessary, the needs of guidelines about pessary, including a learning curve of pessary treatment, the relevant aspects about insertion of the device, its association with other medications, needs for hospitalization, which is the best management for the vaginal discharge pessary related, how to handle the pelvic pain after insertion, the urinary symptoms, the obstipation, and the inhibition of preterm labor during pessary treatment, and finally, what are the relevant aspects about the withdrawal of cervical pessary?

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

Background Preterm-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 findings We 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. Conclusions These 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 registration ClinicalTrials.gov ISRCTN 02235181. ClinicalTrials.gov NCT02235181.