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.