Results
The characteristics of the study cohort of 166 patients that answered
the questionnaire are demonstrated in in Table 1. Table 2 summarizes the
answers given by the patients. Information received before the insertion
of Arabin pessary was considered adequate in 163/166 cases (98.2%). An
increase of moderate vaginal discharge (mean NRS score 5.3), a side
effect that is also indicated in the instructions, was experienced by
70/166 (42.2%) women. Discomfort or any other side effect were reported
in a minority of cases (13.8% and 16.3%, respectively) (Table 2). Most
women (128/166) reported an improved quality of life (77.1%) and even
more (94.0%) considered the follow-up, received by always the same
physician, adequate (Table 2). Removal was moderately painful for 58/166
women (35%), with a mean NRS score of 6.7 ± 2.1. Patient’s expectations
of treatment outcome were exceeded in the majority of cases (75.3%) and
almost all patients (91.6%) reported that they would choose the pessary
treatment again or recommend it to a friend in a similar situation
(Table 2).
Our study population included 118 Italian and 48 foreign women. There
were no significant differences in the answers given between the two
subgroups, including side effects (p = 0.49), perceived adequacy of the
information (p = 0.56) and of the follow-up received (p = 0.33). Among
singleton pregnancies, 26/118 (22%) had a spontaneous preterm birth
before 34 weeks, while 92/118 (78%) delivered after 34 weeks. 16/43
twin pregnancies (37%) and 4/5 triplet pregnancies (80%) delivered
before 34 weeks secondary to spontaneous preterm labor. 3/166 patients
(2%) had iatrogenic preterm birth (two for vaginal bleeding in placenta
previa, one for HELLP syndrome). One patient (0.6%) required early
removal of the pessary due to discomfort. In general, women who
delivered later (≥ 34 weeks) reported more frequently improvements of
daily life, experience better than expected and the wish to re-use the
device (Table 3).
Finally, we compared our results with respect to side effects and
clinical experience with details reported in RCTs investigating the
outcome after cervical pessary treatment. The results are demonstrated
in Table 4. There seems to be a negative association of increased early
removal with the experience of the clinicians involved in the treatment
and the practical training received.