Comparative assessment of Arabin pessary and cervical cerclage in the management of cervical insufficiency

Abstract

Comparative assessment of Arabin pessary and cervical cerclage in the management of cervical insufficiency Caterina Pizzicaroli1 , Veronica Arciero1 , Ilaria Simonelli2 , Nicola Caporale3, *, Massimo Maria Salvatori1 , Doriana Scaldaferri1 , Silvio Tartaglia4 , Giovanni Larciprete1 1Department of Obstetrics and Gynecology, San Giovanni Calibita Fatebenefratelli Isola Tiberina Hospital, 00186 Rome, Italy 2 Service of Medical Statistics and Information Technology, Fatebenefratelli Foundation for Health Research and Education, AFaR Division, 00186 Rome, Italy 3Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli, IRCCS, 00168 Rome, Italy 4Department of Biomedicine and Prevention, University of Rome Tor Vergata, 00133 Rome, Italy *Correspondence: caporalenicola@gmail.com; nicola.caporale01@icatt.it (Nicola Caporale) DOI:10.31083/j.ceog4805179 This is an open access article under the CC BY 4.0 license (https://creativecommons.org/licenses/by/4.0/). Submitted: 11 April 2021 Revised: 9 June 2021 Accepted: 18 June 2021 Published: 15 October 2021 Background: One of the most important causes of preterm birth (PTB) is cervical insufficiency, which usually it's treated by performing a surgical cervical cerclage (CC). Currently, a valid alternative to surgical treatment is represented by the application of a non-invasive intravaginal silicon device called Arabin® pessary (AP). The aim of the study is to compare these two therapeutic approaches in terms of gestational and neonatal outcomes. Methods: In this observational cohort study, we retrospectively evaluated the pregnant women between 18 and 24 gestational weeks referred to the Department of Obstetrics and Gynecology of San Giovanni Calibita Fatebenefratelli Hospital of Rome from 2015 to 2017 with the diagnosis of threatened preterm birth. The 26 women were divided into groups according to the treatment received: cervical cerclage (Group-1, inpatient) and Arabin® pessary (Group-2, out-patient), both in combination with vaginal progesterone (PG). The primary outcome was the gestational age at delivery, and various secondary maternal and neonatal outcomes were considered. Results: The results do not show a statistically significant difference between the two groups, both in terms of gestational and neonatal outcomes. Considering surgical risks (anesthesia, blood loss), recovery-time and economic costs of CC, AP showed very interesting advantages resulting in more favorable cost-benefits relation. Conclusion: We confirmed once again that out-patient combination of AP and vaginal PG is a safe, noninvasive choice as treatment of PTB. Unfortunately, the small population doesn't allow to define this a noninferiority trial. Further larger randomized controlled studies are needed to reassure clinicians about the efficacy of this combined non-invasive approach. Keywords Cervical insufficiency; Cervical cerclage; Arabin pessary; Late abortion; Preterm birth; Shortened cervix