Material and Methods
At Careggi University Hospital in Florence (Italy) a total of 205 women were treated with Arabin cervical pessary for prevention of preterm birth from June 2010 to June 2020. The treatment was performed by three clinicians who had received extensive training before. The average treatment per physician was 68.3 in this series with individual differences. After the insertion of a cervical pessary there was a second control after 48 hours to verify whether the pessary was still surrounding the cervix and not displaced. Only in case of patients with an extremely short cervical length, an additional transvaginal ultrasound examination was performed to exclude rapid progress of cervical shortening.
Retrospectively the electronic database was used to contact the total cohort. 34/205 women (16.6%) had changed address and 5/205 (2%) refused to participate. The remaining 166 women were contacted and were administered a questionnaire inquiring about their experience before the insertion (adequacy of the information received), during treatment (follow-up, impact on daily life, perceived discomfort and other side effects) and at the time of removal (presence of pain, degree to which patient’s expectation about the treatment were met). The questionnaire is available as Supporting Information (Supporting file 1). For vaginal discharge and pain, numerical rating scales (NRS) from 0 to 10 were used. The pain-intensity level was assigned as follows: NRS: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.29 This study was approved by the Institutional Ethics Committee (Comitato Etico Regionale per la Sperimentazione Clinica della Regione Toscana; approval number: 18058).
The total cohort and specific subgroups were analysed. We chose to compare women who delivered either before or after 34 weeks because this more or less defines the success of treatment, and earlier delivery might have an impact on patient’s reported experience or expectations.
Statistical analysis was performed with Graph Pad INSTAT3 software package (San Diego, CA, USA). Continuous variables were expressed as mean and standard deviation; categorical variables were indicated by percentage. We used the one sample z-test for proportions or the multinomial test to compare questionnaire’s answers in the study population, and the chi-square test to compare the answers between the subgroups. A p-value of < 0.05 was considered significant.