Discussion
One of the main findings of this study was that apart from vaginal discharge no significant side effects or discomfort were experienced by the vast majority of patients. Moreover, the level of patient’s satisfaction was high and only one patient required early removal due to discomfort.
In contrast to the PECEP trial,13,17 in which all women treated with a cervical pessary had vaginal discharge, this symptom was only present in about 50% of our patients. Other clinical trials report a higher rate of vaginal discharge in women with pessary treatment compared to women without pessary in pregnancy, with a highly variable rate reported in the pessary group, depending on the study: 10.5% in Nicolaides et al.,15 86.7% in Saccone et al.,14 and 73.3% in Dugoff et al.30On the other hand, pelvic discomfort is less frequently reported (Table 4). Since in most studies increased vaginal discharge is the most common side effect of pessary treatment, the patient should be advised of this even before positioning it. To prevent accumulation of vaginal fluids, Arabin cerclage pessaries that we used are characterized by perforations of the silicone ring that favour release of vaginal discharge.20 However, it should be remembered that vaginal discharge due to Arabin pessary is not the same as that observed in “triple I” or pPROM. Therefore, there is no indication to treat it with antibiotics. As our study showed, 77.1% of women reported that they had received adequate and comprehensive information about the possibility of vaginal discharge. Communication is an essential part of treatment, as accurate counselling can be helpful in increasing patient’s compliance and satisfaction with the treatment.
Encouraging data in relation to the impact of the treatment on patient’s daily life emerged from our study. The fact that the majority of patients reported positive changes in their lives during treatment may be in part related to the decreased concern about the risk of preterm birth. In addition, the presence of the pessary supporting the cervix may give relief of pressure sensations while walking or standing in some patients.24
Patients of foreign nationality did not report a different experience with the treatment, or a different perception of the assistance and information received compared to Italian patients, while women who delivered before 34 weeks reported adequacy of the information received, positive changes in daily life, sense of satisfaction and consideration of a possible reuse of the device with a lower frequency compared to women who delivered after 34 weeks. This could be explained by the fact that childbirth occurred at low gestational ages and, consequently, in some women a negative experience related to the prematurity of their child may also have had an impact on the reported experience with the pessary.
This is the first study of maternal experience about pessary treatment. A strength of this study is that all women included were assisted by operators that were trained in proper pessary placement. This study also has limitations, which include the retrospective design and the absence of a control group.