Introduction
Globally, preterm birth was reported with an incidence of 10.6% in
2014,1 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.2 Even within Europe, preterm birth rates ranged
between 4.9% in Lithuania and 11.4% in Hungary in
2015.3
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,4 by smoke-free legislation,5by the prevention of teenage pregnancies,6 by
promoting healthy diets,7 or possibly by the use of
medications such as aspirin8 or omega-3-fatty
acids.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.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 singleton13-15 and twin
pregnancies.16-22 It promotes an inclination of the
uterocervical angle as visualized by MRI or
clinically.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
position25,26 or in vitro by biomechanical
engineering.27
However, what has been completely neglected up to now is that a clinical
success also requires experience following a learning
curve.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).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.