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.