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.