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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, in-patient) 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, non-invasive 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.

Abstract Background Spontaneous pregnancy loss and implantation failure after assisted reproductive technologies (ART) are very common occurrences. Although 50–60% of all cases remains unexplained, various predisposing factors, including thrombophilias, have been identified. Thus, the potential benefit of a prophylaxis with low-molecular-weight heparins in improving outcomes has been often investigated over the years. However, the majority of studies are observational and results from randomized clinical trials (RCTs) are inconclusive, probably due to heterogeneity and limited sample size. To cover these unmet needs and to have further data mainly based on the real-life clinical management, we designed these multicenter registries. Methods OTTILIA (Observational sTudy on antiThrombotic prevention in thrombophILIA and pregnancy loss) and FIRST (recurrent Failures in assIsted Reproductive Techniques) registries are two prospective, multicenter, observational studies to evaluate pregnancy or ART outcomes in consecutive women with previous reproductive failures after spontaneous or assisted conception, respectively. All enrolled women are observed from their first visit after positive pregnancy test (OTTILIA) or before commencing a new ART cycle (FIRST) until the end of pregnancy or ART procedure (negative pregnancy test/end of pregnancy, if successful cycle), respectively. Data are collected by means of questionnaires and recorded in a central database. Follow-up investigations are performed during hospital stay, routine clinical follow-up visits or telephone interviews. Primary outcome is live birth rate in the OTTILIA register and clinical pregnancy rate in the FIRST. Discussion Although RCTs are the ‘gold standard’ for evaluating treatment outcomes, we believe that our registries represent a valid alternative in improving knowledge on mechanisms involved in reproductive failures and supporting future clinical decisions. Trial registration NCT 02385461, retrospectively registered 5 March 2015 (OTTILIA); NCT 02685800, registered 10 February 2016 (FIRST).