Rationale and design of two prospective, multicenter, observational studies on reproductive outcome in women with recurrent failures after spontaneous or assisted conception: OTTILIA and FIRST registries.

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: NCT02385461 , retrospectively registered 5 March 2015 (OTTILIA); NCT02685800 , registered 10 February 2016 (FIRST).

Ultrasonographic evaluation of the second stage of labor. Predictive parameters for a successful vaginal delivery with or without neuraxial analgesia: a pilot study.

PURPOSE: The aim of the study was to evaluate the progression and rotation of the fetal head during the second stage of labor using translabial ultrasound and to compare ultrasonographic data obtained in nulliparous women both receiving and not receiving neuraxial analgesia. METHODS: The 49 patients enrolled in the study were divided into two groups according to receiving or not receiving neuraxial analgesia. Every half hour from full dilation to delivery, the ultrasonographic translabial parameters of Angle of Progression, Head Symphysis Distance, and Midline Angle were obtained and recorded by a single operator. Then, these records were compared between the two groups of patients. RESULTS: Patients that underwent neuraxial analgesia presented with increased duration of the second stage of labor, with mean values of Angle of Progression significantly higher and of Midline Angle significantly lower for each time interval studied compared to patients without analgesia. A borderline significant relationship was found between administration of neuraxial analgesia and Head Symphysis Distance. CONCLUSIONS: In this study, we demonstrated that combined spinal-epidural analgesia influences the duration of the second stage of labor and the initial progression and rotation of the fetal head through the birth canal, but not the kind of delivery. A correlation between Angle of Progression values and success in the application of a vacuum has been reported by other authors and confirmed in our study.