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.