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\begin{document}

\title{Patient's experience with Arabin cervical pessary during pregnancy: a
questionnaire survey}



\author[1]{Viola Seravalli}%
\author[1]{Noemi Strambi}%
\author[1]{Alessandra  D’Arienzo}%
\author[1]{Francesco Magni}%
\author[1]{Ludovico Bernardi}%
\author[1]{Anna Morucchio}%
\author[1]{Mariarosaria Di Tommaso}%
\affil[1]{University of Florence}%


\vspace{-1em}



  
  \date{May 24, 2024}


\begingroup
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\selectlanguage{english}
\begin{abstract}
Objective To investigate women's experience with the cervical pessary
for prevention of preterm birth. Design: Retrospecitve questionnaire
study. Setting: Tertiary care hospital in Italy. Population: 166
pregnant women treated with Arabin cervical pessary within one center.
Methods: A questionnaire was administered to all women after delivery.
Main outcome measures: Data about patient's experience before the
insertion (adequacy of the information received), during treatment
(follow-up, impact on daily life, perceived discomfort, side effects)
and at the time of removal (pain, patient's expectation met regarding
the treatment) were analysed. Results: Information received before the
insertion of Arabin pessary was considered adequate in 163/166 (98.2\%).
An increase of vaginal discharge was experienced by 70/166 (42.2\%)
women. Discomfort or other side effects were reported in 13.8\% and
16.3\% of cases, respectively. Overall, 77\% of women reported an
improved quality of life and 94\% considered the follow-up during
pregnancy adequate. Removal was moderately painful for 58/166 (35\%) of
women. Patient's expectations regarding the treatment were exceeded in
the majority of cases (75.3\%). In a final step, we compared our results
to previous studies suggesting that clinical experience of the health
care specialists in charge may explain why the discrepancy of results.
Conclusion: Although some trials report high rates of non-compliant
patients, this could not be confirmed by our study. In contrast, most
women reported a positive experience and were motivated to continue the
treatment when they were continuously followed by experienced
clinicians.%
\end{abstract}%



\sloppy


\textbf{Patient's experience with Arabin cervical pessary during
pregnancy: a questionnaire survey}

\textbf{Viola Seravalli\textsuperscript{1}} \selectlanguage{ngerman}\textsuperscript{¶}\textbf{,
Noemi Strambi\textsuperscript{1}} \textsuperscript{¶}\textbf{,
Alessandra D'Arienzo\textsuperscript{1}, Francesco
Magni\textsuperscript{2}, Ludovico Bernardi\textsuperscript{2}, Anna
Morucchio\textsuperscript{2}, Mariarosaria Di
Tommaso\textsuperscript{1}.}

Department of Health Sciences, University of Florence, Italy

Department of Clinical and Experimental Biomedical Sciences, University
of Florence, Florence, Italy.

Corresponding author:

Viola Seravalli, MD

Email: viola.seravalli@unifi.it

Tel +393336268510

Largo Brambilla 3, 50134 Florence, Italy

\textsuperscript{¶} These authors equally contributed to this work

Running title: Patient's experience with cervical pessary

\textbf{Abstract}

\emph{Objective} To investigate women's experience with the cervical
pessary for prevention of preterm birth.

\emph{Design:} Retrospective questionnaire study.

\emph{Setting:~} Tertiary care hospital in~Italy.

\emph{Population:} 166 pregnant women treated with Arabin cervical
pessary within one center.

\emph{Methods} : A questionnaire was administered to all women after
delivery.

\emph{Main~outcome measures:} Data about patient's experience before the
insertion (adequacy of the information received), during treatment
(follow-up, impact on daily life, perceived discomfort, side effects)
and at the time of removal (pain, patient's expectation met regarding
the treatment) were analysed.

\emph{Results} : Information received before the insertion of Arabin
pessary was considered adequate in 163/166 (98.2\%). An increase of
vaginal discharge was experienced by 70/166 (42.2\%) women. Discomfort
or other side effects were reported in 13.8\% and 16.3\% of cases,
respectively. Overall, 77\% of women reported an improved quality of
life and 94\% considered the follow-up during pregnancy adequate.
Removal was moderately painful for 58/166 (35\%) of women. Patient's
expectations regarding the treatment were exceeded in the majority of
cases (75.3\%). In a final step, we compared our results to previous
studies suggesting that clinical experience of the health care
specialists in charge may explain why the discrepancy of results.

\emph{Conclusion} : Although some trials report high rates of
non-compliant patients, this could not be confirmed by our study. In
contrast, most women reported a positive experience and were motivated
to continue the treatment when they were continuously followed by
experienced clinicians.

\emph{Keywords} : Arabin pessary, preterm birth, patient's experience,
obstetrics, vaginal discharge.



\textbf{Introduction}

Globally, preterm birth was reported with an incidence of 10.6\% in
2014,\textsuperscript{1} with wide variations among continents and
countries in absolute numbers and rates of preterm births, and in
absolute and relative numbers of perinatal and neonatal
death.\textsuperscript{2} Even within Europe, preterm birth rates ranged
between 4.9\% in Lithuania and 11.4\% in Hungary in
2015.\textsuperscript{3}

Primary prevention of preterm birth would be most desirable, but it
demands the involvement of publicly funded and supported health concepts
without immediate benefit to individual health care specialists, by the
implementation of policies to reduce physical stress for pregnant
women,\textsuperscript{4} by smoke-free
legislation,\textsuperscript{5}by the prevention of teenage
pregnancies,\textsuperscript{6} by promoting healthy
diets,\textsuperscript{7} or possibly by the use of medications such as
aspirin\textsuperscript{8} or omega-3-fatty acids.\textsuperscript{9-11}

In contrast, secondary prevention of preterm birth describes treatment
concepts when first signs are already recognizable but expected to be
reversable. Thereby, a short cervical length (CL) measured by
transvaginal sonography is one of the earliest signs and sonographic
assessment of CL is therefore recommended to be applied in high-risk
patients or even for screening in whole populations. Cervical cerclage,
vaginal progesterone and a cervical pessary specially designed to
prevent preterm birth are present options that are discussed for
secondary prevention in singleton and twin pregnancies. The question
which method should be chosen does not solely depend on the methods
themselves but also whether these pregnant women are followed within
dedicated preterm birth clinics by experienced clinicians. Therefore, Di
Renzo et al. already demanded in 2017 clinical training for the
application of cerclage and cerclage pessaries within the European
guideline for Preterm Birth.\textsuperscript{12} However, adequate
practical training is neither described nor audited in many
observational or randomized controlled trials.

During the past decade, Arabin cervical pessary has been investigated in
different settings in both singleton\textsuperscript{13-15} and twin
pregnancies.\textsuperscript{16-22} It promotes an inclination of the
uterocervical angle as visualized by MRI or
clinically.\textsuperscript{23,24} This mechanism is supposed to reduce
the pressure on the lower uterine segment at the level of the internal
cervical os and the cervix as studied in vivo by a change in maternal
position\textsuperscript{25,26} or in vitro by biomechanical
engineering.\textsuperscript{27}

However, what has been completely neglected up to now is that a clinical
success also requires experience following a learning
curve.\textsuperscript{28} Up to now, there are incidental reports on
side effects of the cervical pessary, but women's views and satisfaction
rates have not yet been systematically investigated apart from the rates
of early removal or discharge within randomized controlled trials
(RCTs).\textsuperscript{13,17}

The discrepant rates of complaints, early removal, and success in
preventing preterm birth within both singleton and twin pregnancies
finally motivated us to investigate women's experience with the cervical
pessary within our own cohort of 10 years and to compare the results
with publications where the consideration of a learning curve was no
issue.

\textbf{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.\textsuperscript{29} This study was approved by the Institutional
Ethics Committee (\emph{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 \textless{} 0.05 was considered significant.

\textbf{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 (\selectlanguage{english}[?] 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.

\textbf{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,\textsuperscript{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.,\textsuperscript{15} 86.7\% in Saccone et
al.,\textsuperscript{14} and 73.3\% in Dugoff et
al.\textsuperscript{30}On 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.\textsuperscript{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.\textsuperscript{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.

\textbf{Conclusions}

Although some randomized trials report high rates of non-compliant
patients, this could not be confirmed by our data. In contrast, most
women treated with Arabin pessary for prevention of preterm birth
reported a positive experience, and the main side effect was vaginal
discharge. Women were motivated to continue with the treatment when they
were continuously followed by experienced clinicians.

Disclosure of Interest

The authors report no conflict of interest

Author contributions

VS: project development, data collection, data analysis, interpretation
of data, manuscript writing. NS: project development, data collection,
data analysis, manuscript editing. AD: data collection, manuscript
editing. FM: data collection, data analysis, manuscript editing. LB:
data analysis, manuscript editing. AM: project development, data
analysis, manuscript editing. MDT: project development, interpretation
of data, manuscript editing.

Funding

\emph{No funding was received for this research}

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\textbf{Table 1) Mean characteristics of the study group of 166 women
treated with a cervical pessary for preterm birth by experienced
clinicians during an observation period of 10 years.}\selectlanguage{english}
\begin{longtable}[]{@{}ll@{}}
\toprule
\textbf{Characteristics} & \textbf{Mean} \selectlanguage{ngerman}± \textbf{SD}\tabularnewline
\midrule
\endhead
Age (years) & 34.6 \selectlanguage{ngerman}± 5.3\tabularnewline
Body mass index (kg/m2) & 22.3 \selectlanguage{ngerman}± 3.6\tabularnewline
& \textbf{N. (\%)}\tabularnewline
Ethnicity White Asian Black & 152 (91.6) 9 (5.4) 5 (3.0)\tabularnewline
Nulliparous & 97 (58.4)\tabularnewline
Parous & 69 (41.6)\tabularnewline
History of preterm birth & 23 (13.9)\tabularnewline
\vtop{\hbox{\strut Singleton pregnancy Multiple pregnancy: Twin
pregnancies}\hbox{\strut Triplet pregnancies}} & 118 (71\%) 48 (28.9) 43
(25.9) 5 (3.0)\tabularnewline
Spontaneous preterm birth \textless{}34 weeks in the index pregnancy:
Singleton pregnancy Twin pregnancies Triplet pregnancies & 26/118
(22.0\%) 16/43 (37.2\%) 4/5 (80.0\%)\tabularnewline
\bottomrule
\end{longtable}

\textbf{Table 2) Results of the questionnaire investigating maternal
views and experiences before, during and after treatment with cervical
pessary (n=166)}\selectlanguage{english}
\begin{longtable}[]{@{}lllll@{}}
\toprule
\begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
Related issues\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
Possible answers n (\%)\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
Possible answers n (\%)\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
Possible answers n (\%)\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
p-value*\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Adequate information before insertion\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Yes 163 (98.2\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
No 3 (1.8\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
\textless{} 0.001\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Information received before insertion regarding possible vaginal
discharge\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Yes 128 (77.1\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
No 38 (22.9\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
\textless{} 0.001\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Vaginal discharge during the treatment NRS (Mean \selectlanguage{ngerman}± SD)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Yes 70 (42.2\%) 5.3 \selectlanguage{ngerman}± 2.7\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
No 96 (57.8\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
0.05\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Any other side effect during the treatment\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Yes 27 (16.3\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
No 139 (83.7\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
\textless{} 0.001\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Change in daily life during the treatment\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Yes, positive 128 (77.1\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Yes, negative 11 (6.6\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
No 27 (16.3\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
\textless{} 0.001\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Discomfort during treatment\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Yes 23 (13.9\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
No 143 (86.1\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
\textless{} 0.001\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Adequate follow-up\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Yes 156 (94.0\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
No 4 (2.4\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
No response 6 (3.6\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
\textless{} 0.001\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Expectations regarding the treatment\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Better than I expected 125 (75.3\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Worse than I expected 17 (10.2\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
As I expected 24 (14.5\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
\textless{} 0.001\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Pain at removal NRS (Mean \selectlanguage{ngerman}± SD)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Yes 58 (34.9\%) 6.7 \selectlanguage{ngerman}± 2.1\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
No 108 (65.1\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
\textless{} 0.001\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
In a similar situation would you chose the pessary treatment again or
recommend it to a friend?\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
Yes 152 (91.6\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
No 14 (8.4\%)\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.19\columnwidth}\raggedright\strut
\textless{} 0.001\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}

* One proportion z-test or multinomial test employed. Null hypothesis
value set at 0.50 for dichotomous questions, and 0.33 for three-choice
questions.

NRS, numerical rating scale.

\textbf{Table 3) Results of the subjective experience stratified for
gestational age at deliver of either before or after 34 weeks of
gestation.}\selectlanguage{english}
\begin{longtable}[]{@{}llll@{}}
\toprule
\begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
\textless{} 34 weeks 50 n (\%)\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
[?] 34 weeks 116 n (\%)\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
p-value*\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Adequate information before insertion\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
47 (94.0\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
116 (100.0\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.03\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Information received before insertion regarding possible vaginal
discharge\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
37 (74.0\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
91 (78.4\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.56\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Vaginal discharge during the treatment\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
16 (32.0\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
54 (46.6\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.09\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Any other side effect during the treatment\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
10 (20.0\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
17 (14.7\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.49\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Positive changes in daily life during the treatment\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
29 (58.0\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
99 (85.3\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.007\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Discomfort during treatment\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
6 (12.0\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
17 (14.7\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.81\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Adequate follow up\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
43 (86.0\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
113 (97.4\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.07\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Experience was better than expected\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
25 (50.0\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
100 (86.2\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textless{} 0.001\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Pain at removal\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
13 (26.0\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
45 (38.8\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.16\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Would re-use Arabin pessary\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
38 (76.0\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
114 (98.3\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textless{}0.001\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}

* chi square test\selectlanguage{english}
\begin{longtable}[]{@{}lllllllllll@{}}
\toprule
\begin{minipage}[b]{0.09\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[b]{0.09\columnwidth}\raggedright\strut
\textbf{Our study}\strut
\end{minipage} & \begin{minipage}[b]{0.09\columnwidth}\raggedright\strut
\textbf{Goya et al.} \textbf{2012\textsuperscript{13}}\strut
\end{minipage} & \begin{minipage}[b]{0.09\columnwidth}\raggedright\strut
\textbf{Saccone et al. 2017\textsuperscript{14}}\strut
\end{minipage} & \begin{minipage}[b]{0.09\columnwidth}\raggedright\strut
\textbf{Goya et al. 2016\textsuperscript{17}}\strut
\end{minipage} & \begin{minipage}[b]{0.09\columnwidth}\raggedright\strut
\textbf{Dang et al. 2019\textsuperscript{19}}\strut
\end{minipage} & \begin{minipage}[b]{0.09\columnwidth}\raggedright\strut
\textbf{Liem et al.} \textbf{2013\textsuperscript{16}}\strut
\end{minipage} & \begin{minipage}[b]{0.09\columnwidth}\raggedright\strut
\textbf{Nicolaides et al.} \textbf{2016\textsuperscript{15}}\strut
\end{minipage} & \begin{minipage}[b]{0.09\columnwidth}\raggedright\strut
\textbf{Nicolaides et al.} \textbf{2016\textsuperscript{18}}\strut
\end{minipage} & \begin{minipage}[b]{0.09\columnwidth}\raggedright\strut
\textbf{Dugoff et al. 2018\textsuperscript{30}}\strut
\end{minipage} & \begin{minipage}[b]{0.09\columnwidth}\raggedright\strut
\textbf{Norman et al. 2021\textsuperscript{22}}\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
\textbf{Investigated device}\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Arabin pessary\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Arabin pessary\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Arabin pessary\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Arabin pessary\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Arabin pessary\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Arabin pessary\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Arabin pessary\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Arabin pessary\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Bioteque cup pessaries\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Arabin pessary\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
\textbf{Number of subjects with pessary placed (n)}\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
166\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
190\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
150\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
68\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
148\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
401\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
460\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
588\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
60\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
250\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
\textbf{Singleton/Twin pregnancies}\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Singletons and twins\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Singletons\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Singletons\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Twins\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Twins\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Twins\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Singletons\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Twins\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Singletons\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Twins\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
\textbf{Teaching/ Audit} \textbf{Details}\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
Yes \emph{The treatment was performed by three clinicians who had
received extensive training before}\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
Not specified\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
Yes \emph{The physicians had received practical training in the
placement of the device. Pessary insertion training consisted of a
didactic session and a hands-on session}.\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
Yes \emph{The central team in turn instructed the other centers in the
use of the} pessary\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
Yes \emph{Well-trained staff involved in pessary treatment}\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
No \emph{No specific training was provided}\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
Yes \emph{The research-team members who inserted the pessaries had
received practical training in the placement of the device.}\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
No \emph{Many research team doctors were involved in the insertion of
the pessary and they did not receive supervised training in doing
so}\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
Yes \emph{In addition to didactic and hands-on training, all staff was
required to demonstrate competence in pessary placement on a live
model}\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
\emph{Yes (only by video)} \emph{Inserting obstetricians watched a
training video on pessary insertion, were provided with written guidance
on pessary management, and (at their discretion) practised pessary
insertion on a model prior to first insertion.}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
\textbf{Vaginal discharge}\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
42.2\%\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
100\%\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
86.7\%\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
100\%\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
70\%\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
26\%\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
10.5\%\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
42.1\%\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
73.3\%\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Not specified\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
\textbf{Early removal due to discomfort/pain}\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
0.6\%\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
\textless{}1\% (one patient who needed removal and replacement of the
pessary)\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
0\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
Not specified\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
Not specified\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
\textless{}28 weeks: 30\% 28-32 weeks: 9\% 32 - 36 weeks: 0 32-36 weeks:
4\%\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
10.2\% of participants requested early removal for: -discomfort (5.4\%)
- vaginal discharge (4.1\%) - vaginal bleeding (0.7\%)\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
5\%\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
1.7\% expelled it during sexual intercourse 1.7\% requested pessary
removal due to apprehension regarding potential discomfort with sexual
intercourse\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
11.3\%\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
\textbf{Discomfort during treatment}\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
13.9\%\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
Mean pain score: 4 (scale 0--10) during pessary insertion\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
3.3\%\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
Mean pain score: 4 (scale 0--10) during pessary insertion\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
Discomfort (17\%) Pain 4\%\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
4\%\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
11.4\%\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
5.8\%\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
1.7\% removal for discomfort during sexual intercourse\strut
\end{minipage} & \begin{minipage}[t]{0.09\columnwidth}\raggedright\strut
11.3\%\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
\textbf{Pain during removal (mean score on a 0-10 scale)}\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
6.7\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
7\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Not specified\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
7\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Not specified\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Not specified\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Not specified\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Not specified\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Not specified\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Uncomfortable in 41.3\%\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
\textbf{Clinical results}\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
22\% of singleton and 37\% of twin pregnancies delivered before 34
weeks.\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Among women with CL[?]25 mm, spontaneous delivery \textless{} 34 weeks of
gestation and neonatal composite adverse outcomes were significantly
less frequent in the pessary group than in the expectant management
group\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Among women with asymptomatic short CL [?]25 mm, use of a cervical
pessary, compared with no pessary resulted in a lower rate of
spontaneous preterm birth at less than 34 weeks of gestation\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Cervical pessary associated with significant reduction of PTB
\textless{} 34w in twin pregnancies with short CL [?]25 mm\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
In women with twin pregnancies and cervical length \textless{}38 mm
cervical pessary and 400 mg vaginal progesterone resulted in similar
rates of PTB at \textless{} 34 weeks. The pessary reduced poor perinatal
outcomes. In women with CL \textless{}28 mm, pessary reduced PTB
\textless{}34 weeks and improved composite poor perinatal outcome.\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
No significant difference in total group but a 6-fold reduction of
composite poor perinatal outcome y in the pessary group in patients with
a CL\textless{} 38 mm between 16 and 20 weeks\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
No significant differences in preterm birth \textless{}34 weeks between
singleton pregnancies with pessary placed for short CL\textless{}25 mm
and the expectant management group.\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
No significant differences in preterm birth \textless{}34 weeks between
unselected twin pregnancies with pessary and the expectant management
group.\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Cervical pessary use was not associated with prevention of PTB in women
with a singleton pregnancy, short CL and no prior sPTB\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
Cervical pessary did not reduce preterm birth \textless{}34 weeks nor
composite adverse neonatal outcome in twin pregnancies with CL [?]35 mm
when compared to standard care\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}

\textbf{Table 4) Comparison of our results with those of other studies
in terms of side effects, experience and training of clinicians, and
clinical results.}

PTB, preterm birth. CL, cervical length

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